Stockwinners Market Radar for January 10, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
HOOD | Hot Stocks20:14 EST Cathie Wood's ARK Investment bought 319.3K shares of Robinhood on Monday
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TDOC | Hot Stocks20:13 EST Cathie Wood's ARK Investment bought 169.5K shares of Teladoc on Monday
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PATH | Hot Stocks20:11 EST Cathie Wood's ARK Investment bought 680K shares of UiPath on Monday
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COIN | Hot Stocks20:09 EST Cathie Wood's ARK Investment bought 143.5K shares of Coinbase on Monday
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AVTX | Hot Stocks20:01 EST Avalo Therapeutics names Stephen Smolinski as Chief Commercial Officer - Avalo Therapeutics announced the appointment of Stephen Smolinski as Chief Commercial Officer, effective January 3, 2022.
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SYRS | Hot Stocks19:58 EST Syros Pharmaceuticals updates on clinical development program - Earlier today, the company's CEO Nancy Simonian stated: ""2022 promises to be a transformative year as we continue to advance our studies of tamibarotene, SY-2101, and SY-5609. We are looking forward to three clinical data readouts this year as well as pivotal data from the SELECT-MDS-1 trial in late 2023 or early 2024. Additionally, in the second half of this year we expect to nominate our new development candidate from our CDK12 program, highlighting the productivity of our gene control discovery engine and our expertise in CDK inhibition. Together, we believe these upcoming milestones will provide insight into the clinical potential of our development-stage assets and lay the foundation for our long-term growth as we advance Syros into a fully integrated biopharmaceutical company. We are pleased with our recent interactions with the U.S. Food and Drug Administration on the Phase 3 clinical trial design of SY-2101, which we now expect to initiate in the first quarter of 2023. In addition, based on preclinical data that supports CDK7 inhibition's potential across a range of hematologic malignancies, we expect to start in the second half of this year a Phase 1 single agent study of SY-5609 in patients with relapsed blood cancers, including B-cell lymphomas, prior to moving into specific indications. We are excited to be the first company to advance a CDK7 inhibitor into hematology clinical development. The trial results have potential to benefit a broader patient population as well as demonstrate CDK7 inhibition as a novel approach for many difficult-to-treat hematologic cancers." The company also indicated that "based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into 2023."
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NVEI | Hot Stocks18:54 EST Nuvei integrates with Dapper Labs' Flow - Nuvei has announced it has "integrated with Flow, a Web3 platform designed for consumer-friendly blockchain applications. This is a significant milestone in accessible NFT purchasing and unique stablecoin processing on the blockchain, enabling a frictionless checkout experience, powered by Nuvei, for dapps built on Flow. Flow's next-generation, environmentally-friendly blockchain allows developers to build crypto- and crypto-enabled businesses, and users to create digital assets tradable on open markets. Nuvei brings an innovative and agile processing partner for those building on Flow by allowing users to pay with FUSD, the most prominent USD-based stablecoin on Flow."
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BRCN | Hot Stocks18:52 EST Burcon NutraScience CEO Johann Tergesen to step down - Burcon NutraScience announced that Johann Tergesen will be stepping down as President and CEO. Mr. Tergesen will remain CEO until either a successor is appointed by the Company's board of directors, or no later than February 28, 2022. To ensure an orderly transition, he will continue in an ongoing capacity as an advisor to the company and Burcon's board of directors. The company has engaged Kincannon & Reed, an executive search firm specialising in the food and agribusiness sectors, to assist in recruiting a new CEO.
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DXCM | Hot Stocks18:49 EST DexCom CEO: G7 CGM system is about 60% smaller than G6 - In an interview on CNBC's Mad Money, Kevin Sayer said DexCom can make an impact when people first get diagnosed with diabetes. He noted that the international market is a "key pillar" in the company's growth plans and expects the G7 CGM system to launch there.
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FCPT | Hot Stocks18:19 EST Four Corners Property Trust acquires VCA Animal Hospital property for $1.7M - Four Corners Property Trust announced the acquisition of a VCA Animal Hospital property for $1.7M. The property is located in a highly trafficked corridor in Michigan and is corporate-operated under a net lease with approximately 7 years of term remaining. The transaction was priced at a 7.0% going-in cash capitalization rate, exclusive of transaction costs.
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RIO WAB | Hot Stocks17:44 EST Rio Tinto orders Wabtec FLXdrive battery locomotives to cut emissions - Wabtec (WAB) and Rio Tinto (RIO) announced an order for four FLXdrive battery-electric locomotives to support sustainable operations of the mining company's rail network in the Pilbara region of Western Australia. The 100%, battery-powered locomotive will help Rio Tinto's effort to achieve a 50% reduction in Scope 1 and 2 carbon emissions by 2030. Rio Tinto ordered the newest version of the FLXdrive battery-electric locomotive, which features an energy capacity of 7 megawatt-hours. Based on the route from the mine to the port at Dampier in Western Australia and Rio Tinto's mainline rail operations, the FLXdrive is anticipated to reduce the company's fuel costs and emissions in percentage by double digits per train. Wabtec will deliver the FLXdrive battery locomotives to Rio Tinto in 2023. The mining company plans on using the locomotives in multiple applications including as a shunter in the railyard and ultimately in mainline service. In mainline operations, Rio Tinto currently uses three diesel-electric locomotives in a consist to pull trains with 240 cars hauling about 28,000 tons of iron ore. The FLXdrives will transition from the diesel locomotives in mainline service to form a hybrid consist, and recharge during the trip through regenerative braking and at charging stations. Wabtec's next generation energy-management software system will determine the optimal times to discharge and recharge the batteries along to route ensuring the most fuel-efficient operation of the entire locomotive consist during the trip.
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RIVN | Hot Stocks17:39 EST Rivian Automotive drops after WSJ reports COO left in December - Rivian dropped over $4.00 per share or approximately 5%, to around $77.20 per share, in after-hours trading on Monday, after the Wall Street Journal reported the company's chief operating officer, Rod Copes, had retired from the company in December.
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RCI | Hot Stocks17:32 EST Rogers Communications appoints Tony Staffieri as CEO - Rogers Communications announced that Tony Staffieri has been appointed president and CEO of the company effective immediately. The appointment follows a search by the Rogers board of directors that commenced on November 16 2021, when Staffieri was appointed interim CEO. Staffieri has also been appointed to the board of directors. "The appointment of Tony as President and CEO puts Rogers in a strong position as we prepare for the closing and integration of the Shaw transaction in the first half of 2022," said Edward Rogers, chairman of the board. "This is a pivotal point in the company's history and the Board has full confidence in Tony's ability to lead Rogers as we move forward."
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PFE | Hot Stocks17:25 EST Pfizer awarded $442.13M Army contract modification for Paxlovid - Pfizer was awarded a $442.13M modification to a contract to produce 835,000 Paxlovid oral antiviral therapeutic treatments for administration, vendor-managed inventory and distribution activities. Work will be performed in New York, New York, with an estimated completion date of March 31, 2023. Fiscal 2022 research, development, test and evaluation, Army funds in the amount of $442.13M were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.
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RIO | Hot Stocks17:23 EST Rio Tinto buys first battery-electric trains for Pilbara - Rio Tinto announces that it "has agreed to purchase four battery-electric trains for use in the Pilbara region of Western Australia as part of the company's strategy to reduce its carbon emissions by 50 per cent by 2030. Rio Tinto purchased the four 7MWh FLXdrive battery-electric locomotives from Wabtec Corporation with production due to commence in the United States in 2023 ahead of initial trials in the Pilbara in early 2024. The locomotives, used to carry ore from the company's mines to its ports, will be recharged at purpose-built charging stations at the port or mine. They will also be capable of generating additional energy while in transit through a regenerative braking system which takes energy from the train and uses it to recharge the onboard batteries."
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NBEV | Hot Stocks17:21 EST NewAge CEO Brent Willis to resign, effective immediately - On January 10, NewAge filed a Form 8-K with the U.S. SEC announcing that the NewAge Board of Directors and the CEO, Brent Willis, have agreed that Willis will resign as CEO, Director, and employee, effective immediately.
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CIVB | Hot Stocks17:07 EST Civista Bancshares to acquire Comunibanc Corp. for $50.2M - Civista Bancshares and Comunibanc Corp., the parent company of The Henry County Bank announced the signing of a definitive merger agreement pursuant to which Civista will acquire Comunibanc. Based on financial data as of September 30, 2021, the combined company would have total assets of approximately $3.3B, total net loans of approximately $2.1B and total deposits of approximately $2.7B. The acquisition of Comunibanc will add seven branches in Henry and Wood Counties in Northwest Ohio and approximately $276M in low-cost core deposits. As of September 30, 2021, Comunibanc also reported total assets of $329M and total loans of $165M. This acquisition will allow Civista to bring its commercial lending platform to Comunibanc's markets and deploy Comunibanc's excess liquidity position with its 60% loan-to-deposit ratio. With the Northwest Ohio market, the Toledo MSA is the fifth largest market in Ohio with over $17B in deposits and is the second fastest growing major Ohio MSA. Subject to the terms of the merger agreement, which has been unanimously approved by the boards of directors of both companies, each share of Comunibanc common stock will receive 1.1888 shares of Civista common stock and $30.13 in cash. This implies a deal value of approximately $50.2M in the aggregate or $60.59 per Comunibanc share based on the closing price of Civista's common stock on January 7, 2022 of $25.62. Civista and Comunibanc anticipate that the transaction will qualify as a tax-free reorganization for the portion of the merger consideration exchanged for Civista common stock. The transaction is expected to close in the second quarter of 2022, subject to the required approval of the Comunibanc shareholders, receipt of all required regulatory approvals and fulfillment of other customary closing conditions. Under terms of the merger agreement, the directors of Comunibanc have agreed to vote all Comunibanc shares that they own in favor of the merger. In addition, after closing one of the Comunibanc directors will join the Civista Bank board of directors. In preparation for the merger, extensive due diligence was performed over a multi-week period. Under the proposed merger terms, the acquisition of Comunibanc is expected to be 10% accretive to Civista's EPS in 2023 and thereafter. In addition, any tangible book value dilution created in the transaction is expected to be earned back in approximately 2.9 years after closing. Post-closing, Civista's capital ratios are expected to continue to exceed "well-capitalized" regulatory standards.
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GBNH | Hot Stocks17:02 EST Greenbrook TMS COO Roerto Drassinover steps down - Greenbrook TMS Inc. announced that Roberto Drassinower will be stepping down from his role as Chief Operating Officer of the company, effective immediately, but will continue to provide advisory services to the company pursuant to the terms of a consulting agreement with the company. Drassinower commented: "I am excited to continue supporting Greenbrook and Bill Leonard in our growth strategy for the business while being able to take time to spend with my family."
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ZIVO | Hot Stocks17:01 EST Zivo Bioscience names Chairman John Payne as President and CEO - Zivo Bioscience announces that Chairman of the Board John Payne has been named President and CEO of the company. Payne succeeds Andrew Dahl. Payne has served as a member of the ZIVO Board of Directors since July 2013 and as Chairman since December 2019.
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OR | Hot Stocks17:01 EST Osisko Gold earns roughly 19,830 attributable gold equivalent ounces in Q4 - Osisko Gold Royalties Ltd provided an update on its fourth quarter 2021 deliveries, sales and cash margins, as well as a recap of certain asset advancements over the course of 2021 that will continue to provide meaningful catalysts in 2022. Osisko earned approximately 19,830 attributable gold equivalent ounces in the fourth quarter of 2021, for a total of approximately 80,000 GEOs in 2021, in line with its annual guidance of 78,000 - 82,000 GEOs. These figures exclude 3,042 GEOs earned in the fourth quarter (and 9,210 GEOs earned in 2021) from the Renard diamond stream. Osisko recorded preliminary revenues of C$50.7 million during the fourth quarter and preliminary cost of sales (excluding depletion) of C$3.7 million resulting in a cash margin of approximately C$47.0 million, a quarterly record from the royalty and stream interests. Osisko's cash margin was approximately 93% during the fourth quarter of 2021 (97% excluding the Renard diamond stream).
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CNP | Hot Stocks16:54 EST CenterPoint Energy completes sale of gas distribution businesses - CenterPoint Energy "announced that it has successfully completed the previously announced sale of its natural gas distribution utilities in Arkansas and Oklahoma to Summit Utilities, Inc. The assets include approximately 17,000 miles of main pipeline in Arkansas, Oklahoma and Texarkana, serving more than 500,000 residential and business customers. The transaction received all necessary federal and state regulatory approvals, including from the Arkansas Public Service Commission, Oklahoma Corporation Commission and Federal Energy Regulatory Commission. Summit will immediately assume responsibility for serving CenterPoint Energy's former customers in Arkansas, Oklahoma and Texarkana."
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BKD | Hot Stocks16:51 EST Brookdale Senior Living reports December-end occupancy 74.5% - Brookdale Senior Living reported its consolidated occupancy for December 2021 at 74.5% vs. 74.3% in November, stating: "December was the 10th consecutive month of weighted average occupancy growth and it was also the first December since 2012 to deliver sequential occupancy growth. Fourth quarter weighted average occupancy increased 100 bps, compared to third quarter."
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SANA | Hot Stocks16:36 EST Sana Biotechnology, Iaso and Innovent Biologics enter license agreement - Sana Biotechnology, Iaso Biotherapeutics and Innovent Biologics (IVBXF) jointly announced that the companies entered into an agreement pursuant to which Sana obtained from Iaso Bio and Innovent non-exclusive commercial rights to a clinically validated fully-human BCMA CAR construct for use in certain in vivo gene therapy and ex vivo hypoimmune cell therapy applications. Iaso Bio and Innovent will receive an upfront payment and are entitled to receive up to approximately $204M in potential development and regulatory milestone payments across up to six products, as well as royalties. B cell maturation antigen, or BCMA, has been validated as a target for autologous CAR T therapy in relapsed and/or refractory multiple myeloma, or RRMM. The BCMA CAR licensed from Iaso Bio and Innovent to Sana is a key part of an autologous BCMA-directed CAR T cell therapy product that has shown promising clinical safety and efficacy data in China. The latest data from the phase 1/2 clinical study was jointly presented by Iaso Bio and Innovent at the 63rd American Society of Hematology Annual Meeting in Atlanta. CT103A demonstrated an overall response rate of 94.9%, a minimal residual disease, or MRD, negativity rate of 93.7%, and a complete response/stringent complete response rate of 58.2% in 79 RRMM patients. CT103A also demonstrated activity in patients who had previously received CAR T therapy: among 13 such patients, the ORR was 76.9%, with 61.5% of those patients achieving very good partial response or better and 46.2% achieving CR/sCR. In February 2021, CT103A was granted Breakthrough Therapy Designation by China's National Medical Products Administration for the treatment of RRMM.
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STAG | Hot Stocks16:35 EST STAG Industrial announces CEO succession plan, new CFO - STAG Industrial announced that pursuant to ongoing management succession planning by the board, the company expects that on July 1, Benjamin Butcher, the company's current chairman and CEO, will become executive chairman and that William Crooker, the company's current president, will be appointed CEO and join the board. The company further announced that its board appointed Matts Pinard to the role of executive VP, CFO and Treasurer. Crooker, the company's CFO and Treasurer until Pinard's appointment, will continue in his role as president until assuming additional duties in July pursuant to the succession plan.
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UNFI | Hot Stocks16:34 EST United Natural Foods names Matt Echols chief corporate affairs officer - United Natural Foods, Inc. announced that Matt Echols has been appointed to the newly created position of Chief Corporate Affairs Officer with oversight of the Company's Corporate Communications and Engagement, Public Policy, Government Relations, and Environmental, Social and Governance teams. Echols, who most recently has served as Global Vice President for Public Affairs, Communications and Sustainability at The Coca-Cola Company, will join UNFI on March 1, 2022 and will report to Sandy Douglas, UNFI's Chief Executive Officer. "As we continue our journey to improve the way we serve existing and future customers, we know we need stronger and fully integrated capabilities across Environmental, Social and Governance (ESG), Communications, and Public Policy. This new role reflects our belief in the value created for UNFI's customers, suppliers, associates and other stakeholders through these critical areas," said Mr. Douglas. "Matt is a seasoned senior executive with the business acumen and subject matter expertise to lead our integrated approach. He will be a valuable member of our executive leadership team."
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ALLO CLLS | Hot Stocks16:33 EST Allogene Therapeutics says FDA lifts hold on clinical trials - Cellectis (CLLS) stated that its licensed partner, Allogene Therapeutics (ALLO) announced that the U.S. FDA has lifted the hold on its clinical trials. The FDA had placed a clinical hold on all five of Allogene's clinical trials on October 7, 2021 following a report of a chromosomal abnormality detected in ALLO-501A CAR+ T-cells from a single patient enrolled in Allogene's ALPHA2 study. Allogene reported that the investigations concluded that the chromosomal abnormality was unrelated to TALEN gene editing or Allogene's manufacturing process and had no clinical significance. The abnormality was not detected in any manufactured AlloCAR T product or in any other patient treated with the same ALLO-501A lot. The abnormality occurred in the patient after the cell product was administered. It involved regions of the T cell receptor and immunoglobulin genes known to undergo rearrangement as part of the natural T cell or B cell maturation process. Allogene also announced that following the lift of the clinical holds and pending final discussions with the FDA, Allogene intends to initiate a Phase 2 pivotal trial of ALLO-501A in relapsed/refractory large B-cell lymphoma mid-year 2022. Allogene's allogeneic CAR-T programs utilize Cellectis' technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries. Allogene has an exclusive license to Cellectis' technologies for ALLO-715, ALLO-605 (both directed at BCMA) and ALLO-316 (directed at CD70) and holds development and commercial rights for these investigational product candidates.
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ESGR AHL | Hot Stocks16:33 EST Enstar Group announces $3.12B LPT transaction with Aspen - Enstar Group Limited (ESGR) announced that one of its wholly owned subsidiaries has reached an agreement for a ground-up loss portfolio transfer with Aspen Insurance Holdings Limited (AHL) for its 2019 and prior business. In the LPT transaction, Enstar's subsidiary will reinsure losses incurred on or prior to December 31, 2019 on Aspen's diverse mix of property, liability and specialty lines across the U.S., U.K. and other jurisdictions. Enstar will assume net loss reserves of $3.12B inn the LPT transaction, which is subject to a limit of $3.57B. The existing adverse development cover between the parties that closed in June 2020, under which Enstar assumed $770M of loss reserves, will be absorbed into this LPT. Completion of the transaction is subject to regulatory approvals and satisfaction of various other closing conditions, during which time the ADC will remain in place. Premium and reserves under the LPT will be adjusted at closing for claims paid on and after the October 1, 2021 effective date. The transaction is expected to close in the first half of 2022.
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FTI | Hot Stocks16:32 EST TechnipFMC announces sale of stake in Technip Energies - TechnipFMC plc announced the sale of 9M Technip Energies N.V. shares through private sale transactions. The sale price of the Shares in the Sale is set at EUR 13.15 per Share, yielding total gross proceeds of EUR 118.4M. Upon completion of the Sale, representing approximately 5% of Technip Energies' issued and outstanding share capital, TechnipFMC retains a direct stake of approximately 7% of Technip Energies' share capital.
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FUSN AZN | Hot Stocks16:31 EST Fusion announces nomination of therapy candidate into IND-enabling studies - Fusion Pharmaceuticals Inc. (FUSN) announced nomination of the first targeted alpha therapy candidate under the company's collaboration agreement with AstraZeneca (AZN). Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion's Fast-Clear linker technology to radiolabel an AstraZeneca-owned bispecific antibody with the alpha-emitting isotope, actinium-225. "Fusion is at the forefront developing a new wave of cancer therapies using alpha-emitting medical isotopes and various targeting vehicles," said John Valliant, Ph.D. "One of the pillars of our platform is to create next-generation immunoconjugates, and we are excited to be working with AstraZeneca to pursue a novel radioimmunoconjugate for oncology. We had strong alignment among our joint development committee to move this novel TAT forward into a planned Phase 1 study and we look forward to sharing more information as we approach the investigational new drug application (IND) filing." Under the terms of the previously announced collaboration agreement, Fusion will be operationally responsible for preclinical development through first-in-human studies, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development. IND enabling studies are ongoing.
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INTC MU | Hot Stocks16:27 EST Intel jumps 5% to $58.15 after naming new CFO
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IMNM | Hot Stocks16:25 EST Immunome receives clinical hold letter from FDA in response to IMM-BCP-01 IND - Immunome, Inc. announced an update regarding its Investigational New Drug submission for IMM-BCP-01, a three-antibody cocktail, for the treatment of SARS-CoV-2. The company received a clinical hold letter from the U.S. Food and Drug Administration in response to its recently submitted IND requesting further information related to the preparation and administration of IMM-BCP-01 at clinical sites. The company has already initiated the requisite work and expects to provide the requested information quickly. Unrelated, the FDA also provided in the same letter valuable guidance on the clinical protocol for IMM-BCP-01, including patient selection criteria.
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EFC | Hot Stocks16:23 EST Ellington Financial makes equity investment in Sheridan Capital - Sheridan Capital and Ellington Financial jointly announced a strategic partnership whereby EFC made an equity investment in Sheridan Capital, a player in originating commercial real estate bridge loans. "We believe that cementing our partnership with EFC will allow us to continue to provide unique and creative loan products to the market," said Aaron Kurlansky, Principal of Sheridan Capital. "In a competitive sector, we differentiate ourselves by streamlining the loan process and providing dependable products for virtually all asset classes and loan sizes." Laurence Penn, Chief Executive Officer and President of Ellington Financial, added, "We have been investing with the principals of Sheridan Capital for more than a decade. Over that wide range of market environments, Sheridan has continued to provide us with a steady stream of attractive commercial real estate debt investments, all while scaling its business. Meanwhile, Sheridan has built an outstanding reputation as offering efficient and flexible financing solutions to commercial real estate owners. With this strategic partnership, I look forward to continuing to grow the business together."
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BARK | Hot Stocks16:21 EST Bark executive chairman Matt Meeker to become CEO - BARK, Inc. announced that Matt Meeker, Co-Founder and Executive Chairman of BARK, will become Chief Executive Officer, effective immediately. Mr. Meeker had served as Chief Executive Officer of BARK for nine years following its inception in 2011. The incumbent Chief Executive Officer, Manish Joneja, has informed the Board of Directors of his desire to resign in order to remain closer to his family in Seattle and will serve as an advisor to the company through April 2022 to ensure a smooth transition.
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FTI | Hot Stocks16:19 EST TechnipFMC announces voluntary delisting from Euronext Paris - TechnipFMC announced that following a comprehensive review of its strategic objectives, it is proceeding with the voluntary delisting of its shares from Euronext Paris. Following the partial spin-off of Technip Energies and the progressive selldown of the company's remaining ownership stake, the Company has refocused as a pure-play technology and services provider to the traditional and new energies industries. It now has its principal place of business in Houston. These actions have led the Board of Directors to conclude that a single listing on the New York Stock Exchange is more consistent with the company's strategic refocus and shareholder base, and allows the company to better align with its most appropriate peer set. In addition, the company expects that the savings in costs, administrative requirements, and managerial time required to maintain a dual listing can be redirected to other initiatives that contribute to shareholder value. The delisting has been approved by the Board of Directors of Euronext Paris SA and the company's shares will remain listed on the NYSE under the symbol "FTI".
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CNS | Hot Stocks16:19 EST Cohen & Steers reports preliminary AUM $106.6B as of December 31, 2021 - Cohen & Steers reported preliminary assets under management of $106.6B as of December 31, 2021, an increase of $6.4B from assets under management at November 30, 2021. The increase was due to net inflows of $1.5B and market appreciation of $6.1B, partially offset by distributions of $1.2B.
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TRGP | Hot Stocks16:19 EST Targa Resources to repurchase interests in development company JV for $925M - Targa Resources announced that it has executed agreements to repurchase interests in its development company joint ventures from investment vehicles affiliated with Stonepeak for approximately $925M. Targa had approximately $3.2B of available liquidity at December 31, 2021 and intends to fund the DevCo acquisition using available liquidity. The acquisition will close on January 14, 2022. Pro forma, Targa will own a 75% interest in its Grand Prix NGL Pipeline, 100% of its Train 6 fractionator in Mont Belvieu, TX, and a 25% equity interest in the Gulf Coast Express Pipeline. Targa will benefit from a full year of Adjusted EBITDA and cash flows associated with the acquired DevCo JV assets in 2022.
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HRB | Hot Stocks16:18 EST H&R Block appoints Dara Redler Chief Legal Officer - H&R Block announced that Dara Redler is joining the company as Chief Legal Officer, as current General Counsel and Chief Administrative Officer Tom Gerke announces his retirement after serving the company for the past 10 years. Redler previously served as General Counsel and Corporate Secretary for Tilray (TLRY).
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MU INTC | Hot Stocks16:18 EST Micron CFO David Zinsner resigns, Sumit Sadana named interim CFO - Micron (MU) announced that David Zinsner, executive vice president and CFO, has resigned from the company. Zinsner started at Micron in February 2018 and is departing to join Intel (INTC) as its CFO. A formal search for a new CFO has actively commenced. Micron has appointed Executive Vice President and Chief Business Officer Sumit Sadana to the additional role of interim CFO with immediate effect through the transition period. Micron's financial guidance for the second quarter of fiscal 2022 remains unchanged.
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CPHC | Hot Stocks16:17 EST Canterbury Park reinstates dividend at 7c per share - Canterbury Park Holding announced that pursuant to its dividend policy, the Company's Board of Directors has approved the reinstatement of a quarterly cash dividend. Following this action, the Board of Directors has declared a quarterly cash dividend of 7c per share to be paid on January 28 to stockholders of record as of January 18. "Since the start of the COVID-19 pandemic in early 2020, our team has worked diligently to ensure their safety and the safety of our guests in the face of constantly changing health regulations, all while continuing to focus on delivering a great customer experience. As a result, our business weathered the challenges and has benefitted from a steady recovery," said Randy Sampson, Canterbury Park Chairman of the Board, President and CEO. "We have also seen consistent progress with the ongoing development of Canterbury Commons and the land surrounding our facility. With our building momentum and visibility into our ability to generate consistent free cash flow, we are pleased to be in the position to return capital to our loyal shareholders through the resumption of our quarterly dividend."
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DLTH | Hot Stocks16:17 EST Duluth Holdings reports Holiday period sales up 6.4% y/y - Duluth Holdings announced net sales results for the nine-week period from November 1, 2021 through January 2, 2022. Net sales increased 6.4% to $224.3 million compared to $210.9 million in the 2020 Holiday Period and increased 5.4% when compared to the same period in 2019. Retail net sales increased $21.7 million, or 37.8%, to $79.0 million compared to $57.3 million in the 2020 Holiday Period nd decreased 4.5% when compared to the same period in 2019. Direct net sales decreased 5.4% to $145.3 million compared to $153.5 million in the 2020 Holiday Period and increased 11.7% when compared to the same period in 2019. President and CEO, Sam Sato commented, "Our Holiday Period results reflect strength in our product offering, marketing effectiveness and customer demand despite facing continued supply chain headwinds. Our Holiday Period sales growth of 6.4% was achieved with excellent gross margin performance and we are pleased to reaffirm our fiscal 2021 outlook."
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INTC | Hot Stocks16:16 EST Intel appoints David Zinsner CFO - Intel Corporation (INTC) announced that David Zinsner has been appointed as the company's executive VP and CFO, effective Jan. 17. Zinsner has more than 20 years of financial and operational experience in semiconductors and manufacturing, including most recently as executive VP and CFO at Micron Technology (MU). As previously announced, current CFO George Davis will retire from Intel in May and will remain with the company in an advisory role until then to ensure a seamless transition.
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KKR BLK | Hot Stocks16:16 EST KKR names Ryan Stork as COO - KKR & Co. (KKR) announced that Ryan Stork has joined KKR as a Partner and COO. Stork is joining KKR from BlackRock (BLK) where he held multiple leadership roles for more than 20 years, including most recently as Deputy COO.
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TLOFF TSLA | Hot Stocks16:12 EST Talon Metals announces nickel supply agreement with Tesla - Talon Metals Corp. (TLOFF), through its U.S. subsidiary Talon Nickel, announced it has entered into an agreement with Tesla (TSLA) for the supply and purchase of nickel concentrate to be produced from the Tamarack Nickel Project in Aitkin County, Minnesota. "The execution of the agreement follows an extensive and detailed due diligence period performed by Tesla and lengthy negotiations between the parties," Talon stated. Under the terms set out in the agreement, Tesla has committed to purchase 75,000 metric tonnes of nickel in concentrate, representing a portion of the metals projected to be produced from the Tamarack Nickel Project. Tesla also has a preferential right under the agreement to negotiate the purchase of additional nickel concentrate over and above the initial 75,000 metric tonne commitment. "The Talon team has taken an innovative approach to the discovery, development and production of battery materials, including to permanently store carbon as part of mine operations and the investigation of the novel extraction of battery materials. Responsible sourcing of battery materials has long been a focus for Tesla, and this project has the promise to accelerate the production of sustainable energy products in North America," said Drew Baglino, SVP of Powertrain and Energy Engineering at Tesla. Reference Link
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GBDC | Hot Stocks16:11 EST Golub Capital announces $867.7M in new middle-market originations in Q1 - Golub Capital announced that it originated $867.7M in new middle-market investment commitments during the three months ended December 31, 2021. Approximately 88% of the new middle-market investment commitments were one stop loans, 4% were senior secured loans and 8% were equity and other securities. Of the new middle-market investment commitments, $765.7M funded at close. Total investments at fair value are estimated to have increased by approximately 5.1%, or $251.9M, during the three months ended December 31, 2021 after factoring in debt repayments, sales of securities, net fundings on revolvers and net change in unrealized gains (losses).
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ECOR | Hot Stocks16:10 EST electroCore announces publication of PREMIUM II trial data in Cephalalgia - electroCore announced the publication of a peer-reviewed paper, entitled "Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial" in Cephalalgia, the official journal of the International Headache Society, or IHS. The paper reports the results of a randomized, double-blind, sham-controlled trial conducted at twenty-seven sites across the United States. Originally designed and powered to randomize 400 patients, the study was closed early due to COVID-19 after enrolling 231 subjects. The results of the study showed a decrease in the number of monthly headache days of 4.6 vs. -3.0 for sham with 44.87% of subjects in the gammaCore group having greater than a 50% reduction in the number of migraine days per month compared with 26.81% for the sham group. Quality of life, as measured by the HIT-6, improved by -4.9 points vs. -2.3 for sham. In the subpopulation of patients diagnosed with migraine with aura, the number of headache days decreased by 5.5 days in the nVNS group compared with 2.7 in the sham group, a therapeutic gain of greater than 100% compared to sham. These findings are consistent with previous reports on the mechanisms of action that suggest nVNS may be particularly effective in patients with migraine with aura.
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ALGM | Hot Stocks16:08 EST Allegro MicroSystems announces CFO Walsh to retire, Derek D'Antilio succeeds - Allegro MicroSystems announced that Paul Walsh, current Senior Vice President Chief Financial Officer, CFO, and Treasurer, will be retiring. He will be succeeded by Derek D'Antilio, who was selected after an extensive search and will be joining the Allegro management team effective January 10. Mr. Walsh will remain in an advisory capacity until February 4, to ensure a smooth and orderly transition of responsibilities. Mr. D'Antilio will report to Ravi Vig, President and Chief Executive Officer, and will oversee the company's global finance team. He joins Allegro with more than 20 years of financial and operating experience in semiconductor and high technology companies and is an accomplished CFO who brings a broad range of financial experience, including a background with global public companies in corporate finance, strategic planning, M&A, capital raising efforts and investor relations.
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FFIV MSFT | Hot Stocks16:08 EST F5 Networks adds Microsoft's James Phillips to board - F5 Networks (FFIV) announced the appointment of James Phillips, President, Digital Transformation Platform Group at Microsoft (MSFT), to its board of directors. In his current role, Phillips leads Microsoft's Digital Transformation Platform Group, a product development organization with more than 15,000 global team members. His team builds and operates Microsoft's business applications and services; and the application, integration, data and intelligence platforms beneath them - collectively powering the digital transformation initiatives of some of the world's largest organizations. His product portfolio includes Dynamics 365, Power Platform, Azure AI Platform, Azure Data Platform, and the Azure IoT Platform.
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LMNR | Hot Stocks16:07 EST Limoneira sees fresh lemon volumes 4.5M-5M cartons for FY22 - The COVID-19 pandemic continues to affect the Company's food service business and industry logistics on a global basis. The Company believes it will experience improving results in fiscal year 2022 compared to fiscal year 2021 due to its stronger position in retail food and club grocery and growing brokered fruit revenues. As food service and export markets recover, the Company expects lemon prices to increase in fiscal year 2022 compared to fiscal year 2021. The Company expects fresh lemon volumes to be in the range of 4.5 million to 5.0 million cartons for fiscal year 2022. Avocado volumes are expected to be in the range of 5.0 million to 6.0 million pounds for fiscal year 2022. The Company expects to receive $80 million from Harvest at Limoneira during the next five fiscal years, beginning in fiscal year 2022.
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RNG | Hot Stocks16:06 EST RingCentral names Mo Katibeh as new COO - RingCentra announced that Mo Katibeh, former Chief Product Officer and Chief Marketing Officer for AT&T Business, will join the company as Chief Operating Officer, reporting to founder, chairman and CEO Vlad Shmunis. Katibeh will be responsible for RingCentral's products, sales, marketing, and customer experience.
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BCAB BMY | Hot Stocks16:06 EST BioAtla, Bristol-Myers announce clinical collaboration - BioAtla (BCAB) announced that it has entered into a clinical collaboration with Bristol Myers Squibb (BMY) to investigate BioAtla's two lead CAB-ADC candidates, BA3011 and BA3021, in combination with Bristol Myers Squibb's anti-PD-1 therapy Opdivo. Under the terms of the agreement, BioAtla and Bristol Myers Squibb will collaborate on clinical trials of separate combination therapies using two of BioAtla's Conditionally Active Biologic Antibody Drug Conjugates, BA3011 and BA3021, each in combination with Opdvio. BioAtla will serve as the study sponsor and will be responsible for costs associated with the trial execution. Bristol Myers Squibb will provide Opdivo clinical drug supply for the study.
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NBSE PHAT | Hot Stocks16:06 EST NeuBase Therapeutics appoints Todd Branning as CFO - NeuBase Therapeutics (NBSE) announced the appointment of Todd Branning as CFO. Branning has more than 25 years of experience with corporate finance and accounting, tax, financial planning and analysis, and investor relations for several publicly traded pharmaceutical companies. Prior to joining NeuBase, Branning was CFO of Phathom Pharmaceuticals (PHAT)
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AMGN | Hot Stocks16:03 EST Amgen, BioLabs LA: Karma Biotechnologies receives second Amgen Golden Ticket - Amgen and BioLabs LA at the Lundquist Institute announced that Karma Biotechnologies has been awarded the second Amgen Golden Ticket in Southern California. Karma Biotechnologies will receive one year of lab space at BioLabs LA at the Lundquist Institute as well as additional facility benefits and connections to Amgen's scientific and business leaders.
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SSKN | Hot Stocks16:03 EST Strata Skin Sciences to acquire TheraClear System assets for $1M - Strata Skin Sciences announced that it has entered into a definitive agreement to acquire assets related to Theravant Corporation's TheraClear System. Theravant develops and markets a novel, FDA-cleared, system for the in-office treatment of many common forms of acne. This acquisition enables Strata 's expansion into the acne treatment market. Under the terms of the transaction, Strata will acquire substantially all of the assets, owned or controlled by Theravant, relating to its acne treatment for an upfront payment of approximately $1M; comprised of $500,000 in cash and $500,000 in common stock. Additionally, the agreement includes certain milestone-based payments.
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MDT | Hot Stocks16:01 EST Medtronic: Micra AV Transcatheter Pacing System approved in Japan - Medtronic announced it has received approval from Japan's Ministry of Health, Labor and Welfare for the sale and reimbursement of the Micra AV Transcatheter Pacing System, and the company will launch the product this month. This approval expands the number of patients in Japan - one of the largest markets in the world - who are eligible to receive the Micra TPS, the world's smallest pacemaker. The Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart are impaired. The Micra TPS is the first-ever leadless pacemaker; its first version was approved in Japan in 2017 for patients who only require single-chamber pacing.
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TFC | Hot Stocks15:01 EST Truist Financial names Denise DeMaio as chief audit officer - Truist Financial appointed Denise DeMaio as chief audit officer, effective Feb. 28. DeMaio will report directly to the Truist Board of Directors' Audit Committee and administratively to CEO Bill Rogers. She succeeds Dale Jeanes, who is retiring after 20 years successfully leading this key function and more than 33 years of distinguished service to Truist and BB&T. DeMaio, who will be based in Charlotte, North Carolina, will lead Truist's internal audit function and provide counsel to senior management on emerging risk trends from the vantage points of governance, processes, technologies and reporting.
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TXG | Hot Stocks14:54 EST 10X Genomics saw headwinds to business in December from omicron surge - Says saw typical year-end budget flush within biopharma. Says was less impacted overall by omicron, which was offset by some cases of budget extension into 2022. Says doesn't see a budget flush so much from the academic customers given the impact of omicron. Says saw headwinds to business in December from omicron surge, resulting from decreased activity in Northeast region, particular with academic customers. Says case counts are "still high" in January. Says gets to see a meaningful change from the situation in December. Says still seeing risks with supply chain related to global logistics and the sourcing of key components. Comments taken from JPMorgan Healthcare conference.
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GM... | Hot Stocks14:05 EST General Motors launches expanded My GM Rewards loyalty program, rewards card - General Motors (GM) announced it has launched the new My GM Rewards loyalty program for Chevrolet, Buick, GMC, and Cadillac customers, featuring three membership tiers and new ways to redeem, calling it "the most comprehensive Automotive Loyalty program for members." The company said today also marks the launch of the new My GM Rewards Card, in collaboration with Marcus by Goldman Sachs (GS) and Mastercard (MA). My GM Rewards originally launched in 2018 and today more than 6 million GM customers are part of My GM Rewards, the company stated. The expanded program allows members to earn and redeem points toward buying or leasing a new GM vehicle, as well as for parts, accessories, paid Certified Service, and select OnStar and Connected Services plans, GM said. Julie Heisel, director of GM Rewards and GM Card, said, "The new My GM Rewards is a big win for our customers with more ways to earn and redeem points, including premium tiers of membership with exclusive offers and opportunities."
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EADSY | Hot Stocks13:51 EST Airbus signs purchase deal with Azorra for 22 A220 aircraft - Airbus said it has signed a purchase agreement with Azorra for twenty-two A220 Family aircraft including twenty A220-300s and two ACJ TwoTwenty aircraft. Azorra is a Fort Lauderdale, Florida, USA, based aircraft lessor focused on executive, regional and mid-size aircraft. Azorra's purchase is the latest endorsement for the A220 Family aircraft and reaffirms the strong market demand for Airbus' newest single-aisle aircraft. "The A220 is ideally suited for Azorra's growing portfolio. We are excited to partner with Airbus on this popular, next generation aircraft. We look forward to offering its superior economics and environmental efficiency to our customers," said John Evans, CEO of Azorra. "We are also thrilled with the opportunity to expand Azorra's executive jet leasing business with the new ACJ TwoTwenty. Azorra's new partnership with Airbus and unique ability to offer fleet transition solutions for airlines and executive jet leases to business aviation customers are key differentiators that bring significant value to our customers."
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EADSY | Hot Stocks13:50 EST Airbus delivered 611 commercial aircraft in 2021 - Airbus said it delivered 611 commercial aircraft to 88 customers in 2021. "Our commercial aircraft achievements in 2021 reflect the focus and resilience of our Airbus teams, customers, suppliers and stakeholders across the globe who pulled together to deliver remarkable results. The year saw significant orders from airlines worldwide, signaling confidence in the sustainable growth of air travel post-COVID" said Guillaume Faury, Airbus Chief Executive Officer. "While uncertainties remain, we are on track to lift production through 2022 to meet our customers' requirements. At the same time we are preparing the future of aviation, transforming our industrial capabilities and implementing the roadmap for decarbonisation." Approximately 25% of commercial aircraft in 2021 were delivered using the established "e-delivery" process, allowing customers to receive their aircraft with minimal need for their teams to travel. In 2021, Airbus doubled its gross order intake compared to 2020 with 771 new sales across all programmes and market segments demonstrating the strength of the company's full product range and signaling renewed market confidence. The A220 won 64 firm gross new orders and several high profile commitments from some of the world's leading carriers. The A320neo Family won 661 gross new orders. In the widebody segment, Airbus won 46 gross new orders including 30 A330s and 16 A350s of which 11 were for the newly launched A350F which also won an additional 11 commitments. In number of aircraft units, Airbus recorded a gross book to bill ratio above one. At the end of 2021, Airbus' backlog stood at 7,082 aircraft.
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EADSY | Hot Stocks13:50 EST Airbus delivered 611 commercial aircraft in 2021
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KR... | Hot Stocks13:47 EST Kroger Health achieves administration of 10 millionth dose of Covid-19 vaccine - Kroger Health announced that it achieved the administration of its 10 millionth dose of COVID-19 vaccine. "As Kroger Health reaches the critical milestone of administering our 10 millionth dose of the COVID-19 vaccine, we lift up our amazing associates across Kroger Health's pharmacies and clinics who continue to inspire through their dedication to providing best-in-class patient care. Our commitment to filling patient prescriptions as well as vaccinating patients the past two years is remarkable as the healthcare industry faces significant challenges. We are tremendously encouraged by our team's ability to continue helping America heal and recover from the impacts of the pandemic," said Colleen Lindholz, president of Kroger Health.
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SYY | Hot Stocks13:26 EST Sysco CEO: Omicron has 'zero' impact on long-term agenda
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SYY | Hot Stocks13:25 EST Sysco to talk more about omicron impact on earnings call in February
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SYY | Hot Stocks13:25 EST Sysco 'noticing,' 'experiencing' impact from omicron, says CEO Hourican - Comments taken from the ICR Conference 2022.
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AAPL | Hot Stocks13:10 EST Apple says it has paid $260B to app developers since 2008 launch - Apple said that its services in 2021 "helped deliver innovative apps, powerful content, and transformative experiences that enrich users' lives around the world in more ways than ever before." "Apple's world-class portfolio of services proved essential in 2021, as people worldwide sought new ways to keep entertained, informed, connected, and inspired," said Eddy Cue, Apple's senior vice president of Services. "With over 745 million paid subscriptions, Apple continues to connect the world's developers, artists, and storytellers with users across more than a billion devices, delivering powerful tools, content, and experiences that enrich their lives in profound ways every day." "Apps and games have become the essential source for the world's most innovative and timely entertainment," the tech giant added. "The efforts, innovation, and creativity of the developers who leverage Apple technology to build these incredible experiences, coupled with the power of the App Store's global platform to connect businesses of all sizes with over 600M people each week across 175 countries, has led to developers selling digital goods and services earning more than $260B since the App Store launched in 2008. This significant number sets a new yearly record for App Store developer earnings while representing just a small fraction of the overall commerce the App Store facilitates, serving as one meaningful marker of how the ecosystem continues to create opportunities and drive economic expansion for entrepreneurs around the world. This holiday season alone, App Store customers spent more than ever before between Christmas Eve and New Year's Eve, driving double-digit growth from last year." Reference Link
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MKSI | Hot Stocks13:01 EST MKS Instruments withdraws from Photonics West 2022 - MKS Instruments announced that it has withdrawn from exhibiting at Photonics West 2022 in San Francisco. "The health and safety of our employees and customers is our top priority, and given the rapid rise in COVID-19 cases, we have made the difficult decision to withdraw from exhibiting at Photonics West 2022," said John Lee, President and CEO of MKS. "We want to extend our thanks to the SPIE team for their work during these uncertain times, and we look forward to returning in 2023."
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RACE | Hot Stocks12:58 EST Ferrari unveils new organizational structure - Ferrari presented a new organizational structure, consistent with its strategic objectives to "nurture the exclusivity of the Brand, enrich product excellence, stay true to its racing DNA and focus on the achievement of carbon neutrality by 2030." "We want to push the boundaries further in all areas by harnessing technology in a unique Ferrari way" - stated Ferrari CEO Benedetto Vigna - "Our new organization will enhance our agility, essential to seizing the opportunities ahead of us in this fast evolving environment." More specifically, the following functions will now report directly into the CEO: Product Development and Research & Development, optimizing the decision making processes within these functions that are crucial to the creation of Ferrari cars and the unique and exclusive experience associated with them. Gianmaria Fulgenzi is appointed Chief Product Development Officer - he has worked for Ferrari since 2002 holding various senior roles in product development, manufacturing and more recently Gestione Sportiva, where he was Head of Supply Chain. Ernesto Lasalandra is appointed Chief Research & Development Officer - he joins Ferrari from STMicroelectronics, where he was Group VP R&D General Manager, building on over 20 years of experience within the hi-tech innovation world. Philippe Krief, already working in Ferrari, will be his Deputy building on over 35 years of experience in the automotive sector; Digital & Data, accelerating the digital transformation process throughout the Company, ensuring more data driven and digitally focused processes. Silvia Gabrielli who has worked for Ferrari since 2019 and previously in Microsoft and other global players in the digital domain, is appointed Chief Digital & Data Officer; Technologies & Infrastructures, strengthening the collaboration and alignment between development and manufacturing of our cars, and ensuring the utmost collaboration throughout the entire process. Davide Abate, previously Head of Technologies and who has worked for Ferrari since 2012, is appointed Chief Technologies & Infrastructures Officer; Purchasing & Quality, enhancing strategic partnerships to continue to raise the bar in terms of excellence. Angelo Pesci is appointed Chief Purchasing & Quality Officer - he joins Ferrari bringing over 20 years of experience in Financial Planning, Supply Chain and Product Planning, Services and Operations in STMicroelectronics.
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AXTI | Hot Stocks12:49 EST AXT Inc. announces formal application for subsidiary IPO on STAR Market - AXT, Inc. announced that its wafer manufacturing subsidiary in China, Beijing Tongmei Xtal Technology Co., Ltd., or "Tongmei," has submitted to the Shanghai Stock Exchange, and the Shanghai Stock Exchange has accepted for review, a formal application to list Tongmei's shares in an initial public offering on the Shanghai Stock Exchange's Sci-Tech innovAtion boaRd, otherwise known as the "STAR Market." The company said: "The process of going public on the STAR Market includes several periods of review and, therefore, is a lengthy process. Tongmei does not expect to complete the IPO until the second half of 2022. The process of going public on the STAR Market is complicated and we have little or no experience in taking a company public in China. There can be no assurance that this process will be completed. The listing of Tongmei on the STAR Market will not change the status of AXT as a U.S. public company." "This is a significant achievement and an important milestone for AXT. We founded Tongmei back in 1998. Since then, it has grown into a company that is engaged in the research, development, production and sale of InP substrates, GaAs substrates, germanium substrates, PBN and other high-purity materials, which we believe makes it an attractive offering on the STAR Market. With success in our addressed markets, strong customer traction, and a number of new applications coming to market this year and beyond, we have significant momentum building in our business. If completed, the IPO will provide proceeds that will be invested in Tongmei to enable us to expand capacity to capture high-volume opportunities across our portfolio and develop new products to drive incremental growth and value from market expansion in 5G, data center expansion, telecommunications modernization, healthcare monitoring, microLEDs, and more," added CEO Morris Young.
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GFF | Hot Stocks12:10 EST Voss Capital urge Griffon shareholders to vote for board nominees - Voss Capital issued a public letter to Griffon Corp.'s shareholders and published its proxy website www.renovategriffon.com. The letter read, in part, "Voss Capital is a Houston-based investment partnership that has made a significant investment in Griffon Corp. We have nominated two directors whose mission, if elected, would be to work alongside the other members of Griffon's Board of Directors to improve value for all Griffon shareholders. We discovered Griffon by looking at companies related to our high conviction thesis on home remodeling and immediately saw opportunities for value creation. Griffon has a collection of attractive businesses whose valuation is being depressed due to an outdated conglomerate structure and one of the worst corporate governance profiles in the entire public market prior to our engagement with the Board. We have a history of successfully working with company boards to unlock value. While we do not normally launch proxy contests, in Griffon's case we felt compelled to do so, as management and the Board have refused to acknowledge the need for change at the Company. We are writing to you today to outline our plan for value creation and demonstrate the urgent need for true independent oversight in the Boardroom. Our five-step plan for the Company, as set forth below, would unlock tremendous value for shareholders if appropriately and promptly implemented. In fact, we believe approximately $50 per share could be created for investors following its execution. We urge you to compare the prospects of our five-step plan with the value-destructive status quo under the watch of the current Board and management which has yielded only an 8% total return over the past five years, 61% underperformance versus the proxy peer group, and 171% underperformance versus the peer group under Ron Kramer's tenure. Voss nominees Charlie Diao and Levi Winn are committed, if elected, to overseeing this plan and ensuring that shareholders are prioritized while overseeing Griffon's management team. You can only vote for our nominees on the enclosed BLUE proxy card. If you have already voted a white card from Griffon, a later-dated vote on the BLUE card will revoke your prior vote. Only your latest dated card counts...Griffon's counterarguments are weak and unsupported by relevant data. They say they have performed well and cite a 3-year TSR that begins right after a ~60% drop in the stock in the middle of 2018. This is the rare interval they can point to because the TSR has badly lagged peers for any period longer than three years. They say they have already begun refreshing the Board and feign a desire to clean up their act, but their proposed half-baked measures only kick the can down the road. They say we haven't owned the stock very long. This is true, but it doesn't take much time to see the obvious problems with the Company's governance and the opportunity for value creation. Furthermore, far from being short-term oriented, we have held some core positions in our portfolio for over seven years. The Company cannot justify its outdated conglomerate structure, and we already know from our conversations that the Board cannot defend the executive compensation in any coherent fashion. Our modus operandi and message to the Griffon board is straightforward - if you fulfill your fiduciary duty to maximize shareholder value, you will have our support. If you do not, we will exercise our rights as shareholders to hold you accountable."
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SONY... | Hot Stocks12:05 EST Sony says 'Among Us' leads PS4, PS5 downloads in December in U.S., Canada, EU - Sony (SONY) said on its PlayStation blog that the top-downloaded PlayStation 5 game in the U.S., Canada, and EU in December was Innersloth's "Among Us," followed by "Spider-Man: Miles Morales" in the U.S. and Canada and EA's (EA) "FIFA 22" in the EU. Other top-downloaded PS5 games in both regions included Activision's (ATVI) "Call of Duty: Vanguard," Ubisoft's (UBSFY) "Assassin's Creed Valhalla," and Take-Two's "NBA 2K22." "Among Us" also ranked at the top of PlayStation 4 downloads in both regions for the month. Reference Link
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ONVO | Hot Stocks12:02 EST Organovo files counterclaims in patent lawsuit by Cellink - Organovo Holdings released its first detailed response to the lawsuit Cellink filed against it in Delaware court in 2021. The company said, "At issue in this lawsuit is whether Cellink is infringing Organovo patents. Organovo, as one of the earliest and most prominent 3D bioprinting companies, has built a strong and foundational patent portfolio in the space. Organovo believes that Cellink, as a newer company with limited patent filings, has moved forward without regard to its patents and now is at risk of owing significant license fees and royalties to Organovo. Organovo is accusing Cellink of infringing several of Organovo's patents, and thus Organovo filed counterclaims to the Delaware suit on Friday, January 7, 2022, and asserted an additional patent against Cellink. With trial set for April 2023, Organovo looks forward to a speedy outcome to the case, with the possibility to gain a damages award that might be tripled if Cellink is determined to have willfully infringed Organovo's patents."
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GME | Hot Stocks12:00 EST GameStop falls -11.1% - GameStop is down -11.1%, or -$15.64 to $124.98.
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BRDS | Hot Stocks12:00 EST Bird Global falls -15.5% - Bird Global is down -15.5%, or -90c to $4.90.
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CURV | Hot Stocks12:00 EST Torrid falls -15.9% - Torrid is down -15.9%, or -$1.70 to $9.00.
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SOXS | Hot Stocks12:00 EST Direxion Daily Semiconductor Bear 3X Shares rises 8.4% - Direxion Daily Semiconductor Bear 3X Shares is up 8.4%, or 32c to $4.12.
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BPT | Hot Stocks12:00 EST BP Prudhoe Bay rises 10.0% - BP Prudhoe Bay is up 10.0%, or 48c to $5.26.
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CNF | Hot Stocks12:00 EST CNFinance rises 11.2% - CNFinance is up 11.2%, or 49c to $4.85.
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SRPT | Hot Stocks11:10 EST Sarepta trading resumes
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WKME HIRE | Hot Stocks11:01 EST WalkMe appoints Chelsea Pyrzenski as chief people officer - WalkMe (WKME) announced the appointment of Chelsea Pyrzenski as Chief People Officer. Pyrzenski will lead WalkMe's efforts in attracting, developing, and retaining top talent as well as oversee Diversity, Equity and Inclusion, and Environmental, Social and Governance programs. Pyrzenski joins WalkMe from HireRight (HIRE), where she served as Chief Human Resources Officer.
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SRPT | Hot Stocks10:51 EST Sarepta says SRP-9001 show 'statistically significant' functional improvements - Sarepta Therapeutics announced topline results from Part 2 of Study SRP-9001-102, an ongoing, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy and tolerability of a single dose of SRP-9001 in 41 patients with Duchenne muscular dystrophy, 21 of whom were in the placebo crossover cohort. SRP-9001 is an investigational gene transfer therapy intended to deliver its micro-dystrophin-encoding gene to muscle tissue for the targeted production of the micro-dystrophin protein. Results were presented today at the 40th Annual J.P. Morgan Healthcare Conference. SRP-9001-treated participants from the placebo crossover group scored a statistically significant 2.0 points higher on the mean North Star Ambulatory Assessment at 48 weeks compared to propensity-score weighted external controls. Mean NSAA scores from these Part 2 participants improved 1.3 points from baseline for the SRP-9001 treated group and the NSAA scores in the external control group declined 0.7 points from baseline. Additional results will be shared at a future medical congress. The safety profile of patients treated in Part 2 of Study 102 is consistent with that seen in Part 1. There were no treatment-related serious adverse events, no deaths and no study discontinuations due to an adverse event. The most common treatment-related adverse event in patients treated in Part 2 was vomiting, similar to Part 1. For patients treated in Part 1, no new safety signals emerged after two years of follow up. Study 102 remains ongoing and all participants continue to be monitored for safety in addition to longer-term assessments of functional outcomes.
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ABMD | Hot Stocks10:33 EST Abiomed announces Impella product approvals in three countries - Abiomed announced that regulators in three countries have granted approvals to Impella surgical products. In the United States, the Food and Drug Administration has granted an Early Feasibility Study Investigational Device Exemption to Impella Bridge-to-Recovery. In Asia, Impella 5.5 with SmartAssist has received approval from Japan's Pharmaceuticals and Medical Devices Agency and Hong Kong's Medical Device Division. The company added: "Impella 5.5 with SmartAssist is a game-changing technology for patients in Japan and Hong Kong. It is a minimally invasive, forward flow, fully unloading heart pump designed by and for heart surgeons with direct or axillary insertion. It received FDA post-market approval two years ago. Since then, it has been used to treat more than 4,000 US patients for indications that include AMI cardiogenic shock, cardiomyopathy and post-cardiotomy cardiogenic shock. Historically, the cardiogenic shock survival rate has been approximately 50%. Impella 5.5 with SmartAssist patients have a 74% survival to explant, with 59% of surviving patients achieving native heart recovery."
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BIIB | Hot Stocks10:29 EST Biogen CEO says Aduhelm Phase 3 data under review at 'top journal' - Biogen CEO Michel Vounatsos is quoted as having said at the JPMorgan healthcare conference that 220 sites are now treating patients with Aduhelm and that Aduhelm's Phase 3 data is under review at a "top journal," according to Bloomberg headlines from the event.
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BIIB | Hot Stocks10:28 EST HHS Secretary orders review of Biogen's Aduhelm after price cut - The Department of Health and Human Services Secretary Xavier Becerra said in a statement: "Today I'm instructing the Centers for Medicare and Medicaid Services to reassess the recommendation for the 2022 Medicare Part B premium, given the dramatic price change of the Alzheimer's drug, Aduhelm. With the 50% price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation." Shares of Biogen reversed earlier losses and are now up 1% to $234.37. Reference Link
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SRPT | Hot Stocks10:23 EST Sarepta trading halted, news pending
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AZYO | Hot Stocks10:06 EST Aziyo Biologics Inc (Class A Stock) trading resumes
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HAYW | Hot Stocks10:04 EST Hayward acquires Water Works Technologies Group, terms not disclosed - Hayward Holdings announced the acquisition of Water Works Technologies Groupm a manufacturer of water features including water bowls and sheer waterfalls with LED lighting options. This acquisition follows the recent acquisitions of two internet of things technology businesses, SmartPower and SmartValve. Together, these acquisitions further extend Hayward's leading position in smart, IoT-enabled technologies designed to bring greater control and ambiance to the pool while simplifying ease of use and cost of ownership. Water Works manufactures a variety of water bowls in both resin and glass in an assortment of colors and finishes as well as Sheer Waterfalls. These high-end water features all have color illumination through LED lighting options which allow Smart app coordination with other pool, spa or landscape lighting colors and shows.
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PATH | Hot Stocks10:02 EST UiPath, Avison Young partner for automation-power real estate experiences - Avison Young and UiPath announced a partnership to deliver the real estate experience of the future. Avison Young will deploy UiPath enterprise automation software to increase the power of its predictive analytics and real estate data, providing brokers and client-facing professionals with faster, more valuable insights on properties to inform client solutions. The company will strategically deploy UiPath robots to free staff of routine, time-intensive tasks, with the long-term vision of providing a robot for every team member.
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CECE | Hot Stocks10:02 EST CECO Environmental to acquire industrial flow control company GRC - CECO Environmental Corp. announced it has agreed to acquire industrial flow control company GRC. The acquisition will be integrated into the company's Effox-Flextor-Mader, Inc. joint venture with Chartwell Investments Entrepreneur & Founder Capital, LLC, the company said in a statement. The transaction is expected to close by April 2022, subject to customary closing conditions, and will be financed with a mix of cash, debt, and equity from the joint venture.
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CAH | Hot Stocks10:00 EST Cardinal Health falls -10.2% - Cardinal Health is down -10.2%, or -$5.51 to $48.73.
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OMI | Hot Stocks10:00 EST Owens & Minor falls -11.2% - Owens & Minor is down -11.2%, or -$5.05 to $40.03.
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CURV | Hot Stocks10:00 EST Torrid falls -16.4% - Torrid is down -16.4%, or -$1.76 to $8.94.
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CNF | Hot Stocks10:00 EST CNFinance rises 7.3% - CNFinance is up 7.3%, or 32c to $4.68.
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BPT | Hot Stocks10:00 EST BP Prudhoe Bay rises 7.6% - BP Prudhoe Bay is up 7.6%, or 36c to $5.14.
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DENN | Hot Stocks10:00 EST Denny's announces partnership with REEF - Denny's announced that the company will partner with REEF, the largest operator of virtual restaurants, logistics, and proximity hubs in North America, to provide new delivery options from virtual kitchens in metropolitan trade areas. The company is actively coordinating with REEF on the launch of initial test market locations which will be a matter of a future announcement. Through this partnership, Denny's plans to expand its footprint across the U.S. and also be a key player in REEF's platform for breakfast offerings.
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CPSR | Hot Stocks10:00 EST Capstar Special Purpose Acquisition Corp. rises 18.7% - Capstar Special Purpose Acquisition Corp. is up 18.7%, or $1.82 to $11.55.
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AZYO | Hot Stocks09:56 EST Aziyo Biologics Inc (Class A Stock) trading halted, volatility trading pause
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PEN SWAV | Hot Stocks09:53 EST Penumbra says not in talks with ShockWave Medical on business combination - In a regulatory filing earlier, Penumbra (PEN) announced that, while it is Penumbra's practice not to comment on rumors or market speculation, the company issued the following statement in response to certain media reports published prior to a large industry conference: "Penumbra is not in discussions with Shockwave Medical to pursue a business combination or similar transaction". Previously, Bloomberg, citing people familiar with the matter, has reported that the companies were discussing a potential tie-up. In early Monday trading, shares of ShockWave Medical (SWAV) are up 5% to $178.24.
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SI | Hot Stocks09:47 EST Silvergate Capital falls -6.6% - Silvergate Capital is down -6.6%, or -$8.47 to $120.02.
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CAH | Hot Stocks09:47 EST Cardinal Health falls -7.8% - Cardinal Health is down -7.8%, or -$4.24 to $50.01.
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CURV | Hot Stocks09:47 EST Torrid falls -15.9% - Torrid is down -15.9%, or -$1.70 to $9.00.
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ZTO | Hot Stocks09:47 EST ZTO Express rises 6.3% - ZTO Express is up 6.3%, or $1.76 to $29.89.
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LOCL | Hot Stocks09:47 EST Local Bounti rises 7.5% - Local Bounti is up 7.5%, or 38c to $5.43.
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CPSR | Hot Stocks09:47 EST Capstar Special Purpose Acquisition Corp. rises 24.5% - Capstar Special Purpose Acquisition Corp. is up 24.5%, or $2.38 to $12.11.
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UBCP | Hot Stocks09:46 EST United Bancorp trading resumes
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IMMX | Hot Stocks09:40 EST Immix Biopharma Inc trading resumes
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UBCP | Hot Stocks09:40 EST United Bancorp trading halted, volatility trading pause
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DISCB | Hot Stocks09:38 EST Discovery Communications trading resumes
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IMMX | Hot Stocks09:38 EST Immix Biopharma Inc trading halted, volatility trading pause
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JWEL | Hot Stocks09:36 EST Jowell Global announces strategic partnership with China Ants Alliance - Jowell Global announced it has established strategic partnership with China Ants Alliance in relation to self-owned brand products, to bring high quality, affordable and trustworthy retail brands to millions of families. Zhiwei Xu, chief executive officer and chairman of Jowell Global, commented: "The retail industry in China is evolving rapidly as new business model, technology and applications emerge. To stand out among the vast product varieties, make meaningful impact and commercialize in the new ecosystem has become an unprecedented challenge to the retailers." Mr. Xu continued, "China Ants Alliance is dedicated to serve mid-and-small sized retailers to strengthen their competitiveness by collaborating self-owned brands, joint procurement, big data, and business school programs. By far, its network covers 95 members across 28 provinces and municipalities in China, reaching total RMB90 billion annual sales by its members. Going forward, Jowell Global and China Ants Alliance will leverage each other's distribution channels to enhance targeted sales and marketing. We will further integrate our online, offline, big data, logistics, services platform, to bring high quality international and domestic products to millions of families through self-owned, celebrities, and international brands."
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WRAP | Hot Stocks09:35 EST Wrap Technologies receives order for BolaWrap 150 Remote Restraint devices - Wrap Technologies announced the first order for its BolaWrap 150 Remote Restraint devices through the Arizona Municipal Risk Retention Pool funding program announced on December 16, 2021. The order was placed following the announcement that the AMRRP Board of Trustees voted unanimously to approve funding to assist its member police agencies statewide in procuring BolaWrap devices for active-duty police officers. The AMRRP represents over 60 rural agencies with more than 1,800 police officers. AMRRP will fund 50% of the purchase price of the BolaWrap and the associated accessories, to help equip police officers that work for its member agencies. The agency order is for full deployment to all active-duty officers including devices, cassettes, and holsters. The Company expects to ship the order in the first quarter of 2022.
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TCBI | Hot Stocks09:35 EST Texas Capital announces launch of Texas Capital Securities - Texas Capital Bancshares announced the launch of Texas Capital Securities, its affiliated broker dealer. Texas Capital Securities is a member of Financial Industry Regulatory Authority, FINRA, and Securities Investment Protection Corporation, SIPC, and is registered with the U.S. Securities and Exchange Commission, SEC, the Texas State Securities Board and other state securities regulators. "With the launch of Texas Capital Securities, we are now able to serve our clients through the entirety of their lifecycles," said Rob Holmes, president and CEO of Texas Capital Bank. "As outlined in our strategic update, Texas Capital Securities enables a suite of investment banking products, offerings, and solutions that will complement and enhance our robust banking, treasury and private wealth capabilities. We are focused on building deep client relationships with the best companies, and today's announcement represents an important step in realizing our strategy to create the flagship financial services firm based in Texas."
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DISCB | Hot Stocks09:35 EST Discovery Communications trading halted, volatility trading pause
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QUOT | Hot Stocks09:34 EST Engaged Capital warns Quotient board of potential legal action - Engaged Capital, the owner of 6.5% of the outstanding shares of Quotient Technology (QUOT), sent a letter to the Company's Board of Directors. The letter read, Engaged Capital is one of the largest stockholders of Quotient Technology, with ownership of approximately 6.5% of the Company's outstanding shares. We are writing today as a follow-up to our prior letter to the Board of Directors of the Company, dated December 15, 2021, which is attached hereto as Exhibit A for your convenience. It has come to our attention from multiple credible sources that Chairman and CEO Steven Boal, with the support of Lead Independent Director Jody Gessow and Chair of the Nominating and Corporate Governance Committee Robert McDonald, is having conversations with third parties regarding selling up to 19.9% of the Company's outstanding shares in the form of convertible preferred securities to then use the proceeds to repurchase shares of common stock of the Company. This is clearly a self-serving act in an attempt to secure votes ahead of a likely proxy contest at the 2022 Annual Meeting of Stockholders, where Messrs. Boal and McDonald are the two directors up for re-election. Other than vote buying, this would be an inexplicable business decision given the highly dilutive effect of an equity capital raise when the stock is trading near all-time lows. Such a transaction would epitomize the blatant vote-buying schemes that run contrary to the duties of care, loyalty and good faith owed by directors, which we explicitly cautioned the Board against entering in the December 15th Letter. In that letter, and during a phone call the same day with Messrs. Gessow and McDonald, we strongly suggested the Board hire its own independent legal counsel and investment bankers as it was clear to us from discussions with people close to the Company that certain members of the Board and management have diverging interests from the Board as a whole. The insights we have gleaned over the last few weeks with regards to Mr. Boal's actions only strengthen our concerns and accelerate the need for the independent directors in the boardroom to become more involved with the Company's governance before it is too late - sacrificing stockholders' interests for the benefit of certain individuals would result in drastic consequences and expose the entire Board to liability, not to mention the damage it would have on each and every director's reputation. Further, we also encourage the independent directors to educate themselves on the toxic culture at Quotient that has led to the Company's chronic and persistent underperformance by speaking with some of the many former executives that have departed over the last few years. We remind you that the tax benefits preservation plan, dated as of November 11, 2021, adopted by the Board generally prohibits stockholders from acquiring 4.9% or more of the Company's outstanding shares of common stock. We submitted a books and records request in accordance with Delaware law back on December 3, 2021 in connection with our concerns that the NOL Pill was adopted to insulate the current Board and to deter or gain an unfair advantage in any potential proxy contest - unfortunately the Company has still not produced any materials in response to our request more than a month later. To then turn around and sell up to 19.9% of the Company in the form of convertible preferred stock would be a clear-cut entrenchment maneuver and breach of the Board's fiduciary duties to stockholders. To be clear, if the Board proceeds with such a transaction, we will commence legal action immediately against the Company and each director individually. We will also seek an injunction to prevent any newly issued shares from being voted while the action is pending and otherwise exhaust all legal remedies to ensure that stockholders' rights are protected at Quotient."
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ALHC | Hot Stocks09:34 EST Alignment Healthcare announces preliminary inpatient utilization for Q4 - Alignment Healthcare announced that its inpatient utilization in the fourth quarter of 2021 was about 5% lower than expected, even amid COVID-19. "This further validates that our AVA health platform and differentiated care delivery model are working," said John Kao, founder and CEO, Alignment Healthcare. "Delivering high-quality care at lower costs allows Alignment to provide consistent value to its members year in and year out. We are able to do well by doing good by improving the health and well-being of our members." Additionally, its health plan membership is at 92,700 as of Jan. 1, 2022, following its annual enrollment period. The growth represents an approximately 16% increase compared to its January 2021 health plan membership. For 2022, Alignment serves 38 counties across four states, representing 7 million seniors, and offers more than 40 health plans.
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KNDI | Hot Stocks09:33 EST Kandi Technologies enters framework agreement with Hunan Hengrun - Kandi Technologies announced that it signed a framework agreement with Hunan Hengrun Automobile to jointly produce battery-swap enabled pure electric vehicles. According to the agreement, Kandi and Hengrun will use their respective capabilities to jointly produce battery-swappable pure electric vehicles. The specific division of labor and cooperation content will be clarified in a separate agreement. The vehicles will be sold under the "Henghe" brand name. Hu Xiaoming, Chairman of the Board of Directors of Kandi, said: "Kandi is pleased to partner with Hengrun. We are a pioneer of EV battery swapping in China. Our accumulated experience of building over 50,000 electric vehicles combined with our dozens of battery-swap patents gives us a strong competitive advantage in this initiative. By utilizing our battery swap expertise and Hengrun's vehicle production expertise, together we expect to create meaningful new benefits for customers and thus promote the development of the China's EV industry."
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HQY | Hot Stocks09:32 EST HealthEquity announces HSA sales estimates for FY21 - HealthEquity announced estimates of HSAs, HSA assets and total accounts for its fiscal year ending on January 31, 2022, reflecting record new openings and custodial asset growth. Estimated HSAs are expected to be approximately 7.2M by January 31, 2022, up from 5.8M a year earlier; Estimated HSA assets are expected to be approximately $19.8B, up from $14.3B at the end of the prior fiscal year with approximately 35% invested compared to 29% at the end of fiscal year 2021, excluding the potential impact from market volatility for the remainder of the month of January 2022; Estimated total accounts are expected to be approximately 14.4M compared to 12.8M at the end of fiscal year 2021, not including suspended commuter accounts; Based upon current economic indicators and rate environment, HealthEquity estimates the yield on HSA cash assets to be at or above 1.55% for fiscal year 2023.; and The Company estimates that it will end its fiscal 2022 year with approximately 120,000 employer clients and 185 network partners consisting of integrated health and retirement plan partners, brokers and benefit advisors. Commenting on the results, Jon Kessler, President and CEO said, "Team Purple and our growing partner ecosystem are on track to deliver approximately 850,000 new organic HSAs this year, up a remarkable 24% from a year ago. Combined with new HSAs from Further and Fifth Third Bank, we will have welcomed nearly 1.6 million new HSA members to HealthEquity and added over $5 billion in HSA assets to our platform during fiscal 2022. More clients and partners are using our proprietary platform to connect health and wealth than ever before."
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IMAC | Hot Stocks09:30 EST IMAC announces expansion in St. Louis area - IMAC announces the relocation and expansion of the Ozzie Smith IMAC Regeneration Center Webster Groves clinic. The clinic opens a new 3,400-square foot space in the Webster Groves Clock Building that is located one block from the center's former location. "IMAC assembled an experienced team of healthcare providers to complement Dr. Whalen's decade of service to the Webster Groves community. I have had the pleasure of caring for patients in the St. Louis community for over 33 years and this team is second to none," said Doug Bouldin, APRN, Founding Partner of the Ozzie Smith IMAC Regeneration Center. "This move reflects our quality of care delivery and we appreciate hosting our services in a modern facility to complement our longstanding Chesterfield clinic."
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SEER | Hot Stocks09:30 EST Seer, Discovery Life Sciences, SCIEX announce proteogenomics consortium - Seer, SCIEX, and Discovery Life Sciences announced they have signed an agreement to form the Proteogenomics Consortium, a collaboration that will enable genomics customers to more easily add deep, unbiased proteomics data to their discovery, translational and clinical studies. Through this multi-year effort, Discovery will establish, expand, and offer deep, unbiased proteomics capabilities to their existing genomics customers using the Seer Proteograph Product Suite and the SCIEX ZenoTOF 7600 platform. This will create a capacity for more than one billion peptides each year to be analyzed and cataloged, allowing the discovery of new protein variants and novel biomarkers, potentially leading to therapeutic breakthroughs. Seer and SCIEX will contribute industry-leading proprietary proteomics technologies and instrumentation, and Discovery will provide its significant scale and expertise in genomics services and biospecimens, to provide services that support population-scale plasma proteogenomic projects. Seer's Proteograph Product Suite includes proprietary engineered nanoparticles, consumables, an automation instrument, and software that enables deep, unbiased proteomics studies with an unprecedented combination of speed, scale, depth, and breadth of data. It accurately surveys thousands of proteins and millions of peptides with precision. The SCIEX ZenoTOF 7600 system is a high-resolution, accurate mass system combining the power of Zeno trap pulsing with electron activated dissolution (EAD) fragmentation technology to uncover structural information, previously inaccessible, and drive the limits of quantification achievable with accurate mass. Discovery will expand their existing biomarker discovery platform as part of their proteomics strategy, expanding the technology platforms available to their worldwide customer base. Their unique service-oriented scientific team will deliver reliable scientific insight for proteogenomic studies.
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TC | Hot Stocks09:30 EST TuanChe establishes EV business unit - Beijing-based automotive marketplace, TuanChe Limited, recently announced the establishment of an electric vehicle business unit as part of its efforts to enter the EV manufacturing sector by working with a diverse team of EV designers, R&D engineers and manufacturing executives. Guided by market research reports and trending data, the company plans to leverage its strong distribution network across more than 240 cities in China to bridge the gap in digital marketing for its EV brands, while tapping into the potential of its new business model.
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FIVE | Hot Stocks09:29 EST Five Below reports holiday period SSS up 7.7% - The company announced that net sales for the Holiday Period increased by 20.6% to $870.9M from $722.3M in the comparable nine-week period from November 1, 2020 through January 2, 2021. Comparable sales for the Holiday Period increased by 7.7%.
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NURO EHTH | Hot Stocks09:29 EST NeuroMetrix names Damkier as VP, Clinical Partnerships - NeuroMetrix (NURO) announced that it has appointed Brandi Damkier as Vice President, VP, Clinical Partnerships. "Damkier will be responsible for expanding the Company's DPNCheck clinical partnerships and advancing the Company's footprint in the value-based healthcare market," the company said. Damkier was most recently at eHealth (EHTH), where she held the position of Director, Value Based Provider Partnerships.
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SFET | Hot Stocks09:28 EST Safe-T consumer privacy solution surpasses 10,000-subscriber milestone - Safe-T Group announced that it has reached a monthly recurring revenue milestone for its recently introduced privacy solution for Apple mobile devices via the App Store, which is now serving more than 10,000 subscribers worldwide. 2021 witnessed growing demand from consumers looking for effective solutions to keep their identities private, strengthening their online safety and anonymity. Seeking to provide consumers with an alternative to existing, often slow and unreliable VPN technology, the Company's new privacy solution was launched in early 2021 through a phased product introduction program. Since its launch, the consumer privacy product has recorded significant subscriber revenue growth, averaging over 50%, quarter-over-quarter. The Company ended 2021 with more than 10,000 paid subscribers, with significant presence in the United States. Recently, the Company has seen strong interest in its solution from users in countries that are invoking more restrictive policies for online activity. To capitalize on the growing interest for enhanced consumer privacy, the Company intends to ramp-up global marketing of the product through the first half of 2022 and launching its availability on Android mobile devices and personal computers.
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BRLT | Hot Stocks09:27 EST Brilliant Earth, Tacori launch exclusive bridal collection - Brilliant Earth announced the debut of a new exclusive bridal collection in partnership with Tacori, which launched today. "The exclusive collection consists of six engagement rings and four wedding bands inspired by the delicate and feminine details of a wedding gown and defined by hidden accents and Tacori's timeless, distinctive aesthetic," the company said. "We are excited to kick off the new year with a deeper partnership with Tacori. Each of these pieces exemplifies our commitment to providing our customers with design individuality, expert craftsmanship, and sustainable fine jewelry," notes Co-Founder and CEO of Brilliant Earth, Beth Gerstein.
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PRGS | Hot Stocks09:27 EST BAYOOTEC cuts frontend development time by 15% with Progress - Progress announced that BAYOOTEC, a full-service software provider based in the DACH region, is using Progress Kendo UI JavaScript component libraries to quickly build and easily customize functional, visually appealing applications for their clients. BAYOOTEC, the enterprise software division of BAYOONET AG, helps more than 800 organizations digitalize and streamline their operations by creating custom solutions that fill the missing link between their different technology tools and data sources. BAYOOTEC needed a comprehensive UI toolbox that would deliver an exceptionally intuitive and easy-to-use interface for their customers.
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NGM | Hot Stocks09:26 EST NGM Biopharmaceuticals sees topline data readout from Phase 2 trial in Q4 - NGM Bio said in a statement that it enters 2022 with a diverse pipeline of seven disclosed programs, including four programs in Phase 2 trials and a wholly-owned oncology portfolio. Anticipated milestones in 2022 include: Topline data readout from the Phase 2 CATALINA trial of NGM621 in patients with geographic atrophy expected in the fourth quarter of 2022; Phase 1a data readout from the ongoing trial of NGM707 monotherapy in patients with advanced solid tumors expected in the second half of 2022; Additional data readouts from the Phase 1a/1b trial of NGM120 expected in the second half of 2022; Initiation of Phase 1 trial for NGM831 expected in the first quarter of 2022; Initiation of Phase 1 trial for NGM438 expected in the second quarter of 2022
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CLSK | Hot Stocks09:26 EST CleanSpark Joins Valkyrie Investments to discuss sustainable bitcoin mining - CleanSpark announced that CEO Zach Bradford will participate in a Valkyrie Investments webinar on sustainable bitcoin mining Thursday, January 13. The event is the first of Valkyrie's new Spotlights webinar series. Bradford will be joined by Kristy-Leigh Minehan.
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XSPA | Hot Stocks09:25 EST XpresSpa announces acquisition of HyperPointe for $5.5M in cash, $1M in stock - XpresSpa Group announced it had entered into an agreement to acquire all of the equity interests of GCG Connect, LLC d/b/a HyperPointe for $5.5M in cash, $1M in common stock, along with potential additional earn-out payments of up to $7.5M over a three-year timeframe based upon future performance, which may be satisfied in cash or company common stock or a combination subject to various terms and conditions. Based upon preliminary and unaudited results, HyperPointe generated $5.5M in revenue and $1.2M in EBITDA during 2021. The transaction is subject to customary closing conditions and is expected to close during the first quarter of 2022.
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GNPX AZN | Hot Stocks09:25 EST Genprex to accelerate opening of Acclaim-1 clinical trial sites - Genprex (GNPX) announced a plan to accelerate the opening of clinical trial sites for the Acclaim-1 clinical trial which combines the company's lead product candidate, Reqorsa Immunogene Therapy with AstraZeneca's (AZN) Tagrisso, as a potential innovative treatment for non-small cell lung cancer. Under a collaboration agreement with a large network of integrated, community-based oncology practices, the opening of four clinical trial sites to enroll patients in the Phase 1 portion of Genprex's Acclaim-1 clinical trial is underway, with an expectation of opening additional sites in the Phase 2 portion of the study.
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NOTV | Hot Stocks09:24 EST Inotiv announces acquisition of Integrated Laboratory Systems for $56M - Inotiv announced that the company has completed the purchase of Integrated Laboratory Systems, a portfolio company of Sier Capital Partners. ILS is a contract research organization specializing in genetic toxicology, in vivo and in vitro toxicology, pathology, molecular biology, bioinformatics and computational toxicology services. Transaction consideration totaled $56M, consisting of: $38M in cash and 429,118 Inotiv common shares having a value of $18M based on the volume weighted average closing price of Company shares as reported by NASDAQ for the twenty trading-day period ending on January 6, 2022. ILS operates in two leased facilities with a total of 50,000 square feet, including a vivarium that is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, and recognized revenue of approximately $20M in 2021.
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DCT | Hot Stocks09:24 EST Duck Creek Technologies expands partnership with Precisely - Duck Creek Technologies announced that Precisely has launched a new integration with Duck Creek Policy, the tenth such integration between Precisely and the Duck Creek Platform to date.
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GNPX | Hot Stocks09:24 EST Genprex to accelerate opening of Acclaim-1 clinical trial sites - Genprex announced a plan to accelerate the opening of clinical trial sites for the Acclaim-1 clinical trial which combines the company's lead product candidate, Reqorsa Immunogene Therapy with AstraZeneca's (AZN) Tagrisso, as a potential innovative treatment for non-small cell lung cancer. Under a collaboration agreement with a large network of integrated, community-based oncology practices, the opening of four clinical trial sites to enroll patients in the Phase 1 portion of Genprex's Acclaim-1 clinical trial is underway, with an expectation of opening additional sites in the Phase 2 portion of the study.
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CLOV | Hot Stocks09:23 EST Clover Health reports Medicare Advantage membership growth of over 25% - Clover Health announced Medicare Advantage membership growth of over 25% versus the beginning of 2021, outpacing the overall industry growth average of approximately 10% year-over-year. Clover began January 2022 already above its previously indicated 2022 average MA membership guidance of 82,000 lives, the company said in a statement.
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GNUS | Hot Stocks09:22 EST ChizComm founders announce exit from Genius Brands - ChizComm Ltd. And ChizComm Beacon Media founders Harold and Jennifer Chizick made the following statement about their exit from Genius Brands, ChizComm and ChizComm Beacon Media. "We are extremely disappointed to be leaving Genius Brands and ChizComm after less than a year of being with Genius Brands. However, our vision on how to best grow the Company does not align well with Genius Brands. Last week, Genius Brands imposed organizational changes that reduced our role in the Company and was a breach of our agreement with Genius Brands. Efforts to resolve this matter in an amicable fashion have been unsuccessful. We believe that we have been terminated on a without cause basis and now have no choice but to depart the Company and explore options for how to recoup the considerable sums remaining due to us. ChizComm staff is at the heart of everything we do. We want to thank this phenomenal team - past and present - that have contributed to building a great organization that prioritizes integrity, drive and passion. And to the ChizComm client base, it has been an honor working in partnership to unlock opportunities and drive growth. Stay tuned for what we do next."
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XENE NBIX | Hot Stocks09:21 EST Xenon outlines key milestones for 2022 - Xenon Pharmaceuticals (XENE) outlined its key milestones for 2022. Ian Mortimer, Xenon's President and Chief Executive Officer stated, "We are entering 2022 with an immense amount of positive momentum, building upon the strong efficacy data from our XEN1101 Phase 2b X-TOLE clinical trial announced in the fourth quarter of 2021. We have set clear business objectives for 2022, with a high priority placed on conducting an end-of-Phase 2 meeting with the FDA in the second quarter of 2022, finalizing our XEN1101 clinical development plans, and initiating our XEN1101 Phase 3 program in the second half of 2022 in adult patients with focal epilepsy. In addition, we are evaluating XEN1101 as a treatment for major depressive disorder, both in an investigator-led study with collaborators at Mount Sinai that is currently underway and in a company-sponsored Phase 2 clinical trial that is expected to begin in the first half of this year." Highlights and Anticipated Milestones: XEN1101: The X-TOLE open-label extension, which has been extended to three years, is expected to continue to generate important long-term data for XEN1101. Xenon is also evaluating other potential epilepsy indications for the future development of XEN1101. In addition, Xenon is collaborating with the Icahn School of Medicine at Mount Sinai to conduct an investigator-sponsored Phase 2 trial of XEN1101 for the treatment of MDD. XEN496: Xenon anticipates that the EPIK study will be completed in the first half of 2023. NBI-921352: Xenon has an ongoing collaboration with Neurocrine Biosciences (NBIX) to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a selective Nav1.6 sodium channel inhibitor. Neurocrine Biosciences is conducting a Phase 2 clinical trial evaluating NBI-921352 in adult patients with focal onset seizures, with data expected in 2023.
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BAESY | Hot Stocks09:20 EST BAE Systems in new support, sustainment, readiness pact with Norwegian Army - BAE Systems has signed a new support, sustainment, and readiness agreement with the Norwegian Army for its fleet of 144 CV90 Infantry Fighting Vehicles, securing a new contract model to support the availability and continuous modernization of the fleet. The seven-year agreement with the Norwegian Defence Logistics Organisation governs the purchase of components and equipment, as well as management and engineering work. It includes maintenance of the System Integration Lab, which ensures that both the customer and BAE Systems can monitor vehicles' current conditions and state of readiness to optimize vehicle performance and capabilities across the fleet."We are pleased to sign this contract to further secure the CV90 fleet for the future, both for ongoing sustainment and incremental capability upgrades," said Maj. Gen. Lars Christian Aamodt, head of the Norwegian Defence Logistics Organisation. "We have today one of the world's most modern Infantry Fighting Vehicles able to advance combined arms with air and sea systems. With this contract we aim to stay in this position for many years to come."
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LWSCF | Hot Stocks09:20 EST Sienna Senior Living says 40 0f 83 residences are in outbreak - Sienna Senior Living provided an update on its operations and announced the appointment of Paul Boniferro to its Board of Directors. In recent weeks, the Omicron variant has impacted Canadians from coast to coast and further highlighted the challenges faced by the healthcare sector across the country. COVID-19/Omicron Update - As of January 7, 2022, 40 of Sienna's 83 owned or managed residences are in outbreak, with active cases of COVID-19 at 32 long-term care and 8 retirement residences. Of these residences, 23 residences have five or less active COVID-19 cases among its residents, including 10 residences with no active COVID-19 cases. An outbreak is defined as two or more confirmed cases of COVID-19 at a residence. Supported by the added protection of booster shots, the majority of residents' and team members' symptoms with respect to the new Omicron variant appear to be mild or moderate. Sienna continues to have stringent precautions in place to manage the impact of Omicron at its residences. Vaccinations - Approximately 90% of Sienna's residents and approximately 42% of Sienna's team members have received their booster dose of a COVID-19 vaccine, according to the most recent data available. In addition, the roll-out of fourth vaccine doses has commenced for eligible residents at Sienna's long-term care residences and Sienna's vaccination task force is supporting the efforts to get third and fourth doses of the vaccine to team members and residents as quickly and efficiently as possible. Staffing - The Company is actively managing staffing pressures as a result of an increased number of team members being required to self-isolate due to the high transmissibility of the Omicron variant. As a result, Sienna anticipates elevated agency staffing needs and continued cost pressures from higher agency labour costs. The Company continues to receive support from government funding in relation to incremental pandemic-related costs. Sienna's sales and marketing efforts continued their momentum in recent months, resulting in high lead generation and sustained occupancy increases with same property average occupancy reaching 85.3% in December 2021, its highest level in nearly two years. Throughout the fourth quarter of 2021, average same property occupancy levels improved each month and rent collection levels remained high.
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XSPA | Hot Stocks09:18 EST XpresSpa announces inducement grant under Nasdaq Listing Rule - XpresSpa announced that a majority of the independent members of its Board of Directors granted an equity award to Ezra Ernst, who was previously affiliated with GCG Connect and who was offered employment with the Company in connection with XpresSpa's acquisition of the equity interests of HyperPointe, as an inducement material to such new employee entering into employment with the Company. The equity award was approved on January 7, 2022, in accordance with Nasdaq Listing Rule 5635(c)(4). The employee will receive stock options to purchase 1,000,000 shares of XpresSpa common stock. The stock options will be issued upon the closing of the acquisition of HyperPointe and employee's hire date in connection therewith and all stock options included within the equity inducement award will have an exercise price equal to the closing price of XpresSpa common stock on the Grant Date.
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DENN | Hot Stocks09:18 EST Denny's sees FY21 adjusted EBITDA $84M-$86M - Sees total general and administrative expenses between $67 million and $69 million, including approximately $13.5 million related to share-based compensation.
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DENN | Hot Stocks09:17 EST Denny's reiterates FY21 outlook
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DSS | Hot Stocks09:17 EST Document Security retains blockchain, digital assets law firm - DSS announced its USX Holdings Company subsidiary has engaged a "leading blockchain, digital assets, and custody law practice in connection with its broker-dealer and alternative trading system as it prepares to launch an innovative marketplace for trading digital assets based on actively traded U.S. equity securities," the company said. USX Holdings, in conjunction with its legal team, will file regulatory submissions and registration statements for digital assets to be traded on the proprietary trading platform. USX Holdings is also applying for money transmitter and virtual currency activity licenses in several states to offer trading in cryptocurrencies. "We look forward to working with our legal team as we move forward on our plans to launch a digital asset exchange targeting corporate issuers, retail traders and investors, crypto hedge funds, proprietary trading firms, and other financial intermediaries. Working with the top law firm in the blockchain space will enable us to accelerate our rollout of this groundbreaking initiative," stated Jason Grady, COO of DSS. "The transformative potential of digital securities is extremely exciting, and we plan to be a major player in the space as we pursue the massive opportunity in the US for a secondary market in securities tokens."
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DENN | Hot Stocks09:17 EST Denny's reports preliminary Q4 domestic systemwide comp sales up 49%
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NNDM | Hot Stocks09:17 EST Nano Dimension develops nano-particle conductive ink with XTPL - Nano Dimension announced a collaboration with XTPL to develop new nano-particle based conductive ink. Nano Dimension and XTPL will focus on the development of new nano-particle conductive ink for AME applications, enabling high conductivity and high-performance material suitable for 3D electronic printing technology for ultra-precise delivery of nanomaterials.
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BMEA | Hot Stocks09:15 EST Biomea Fusion announces 2022 clinical development plans - Biomea Fusion announced that in 2022 it plans to initiate clinical studies to dose its irreversible covalent menin inhibitor, BMF-219, in up to seven different cancer indications as well as in diabetes. Biomea is also confirming the preclinical development timeline of its second program, which the company is on track to announce in the first half of 2022 with an Investigational New Drug application planned within 12 months of candidate selection. "The preclinical profile of BMF-219 is highly compelling due both to its strong control of the menin pathway and very favorable safety profile. I am excited for Biomea to explore the clinical potential of this first-in-class and first-in-human irreversible menin inhibitor in multiple tumor types. We now know that the menin pathway is central to multiple cancer types. Targeting menin with a covalent binder is a very innovative approach and oncologists are eager to utilize BMF-219 for these patients who have limited therapeutic options," said Steve Morris, MD, Independent Medical Oncologist and Leukemia/Lymphoma Expert, Retired Faculty Member, Yale University School of Medicine and St. Jude Children's Research Hospital; who performed basic and translational research regarding menin-driven leukemias and cared for patients with these malignancies during his 30-year career in academic medicine.
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ADPT | Hot Stocks09:15 EST Adaptive Biotechnologies announces CFO Cohen to resign - Adaptive announced that Chad Cohen, chief financial officer, will be resigning from his role, effective on or about February 15, 2022, following the filing of Adaptive Biotechnologies' Annual Report on Form 10-K for the year ended December 31, 2021. Adaptive Biotechnologies' principal accounting officer, Kyle Piskel, will serve as interim CFO after Cohen's resignation. Adaptive Biotechnologies has initiated a search for a permanent CFO with the capabilities and qualifications to help accelerate the development and commercialization of products resulting from the insights provided by its proprietary immune medicine platform. Cohen will continue to work with Adaptive Biotechnologies and Piskel in a consulting capacity to ensure a smooth transition
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ARI | Hot Stocks09:14 EST Apollo Commercial appoints Anastasia Mironova as CFO - Apollo Commercial Real Estate Finance announced the Board of Directors appointed Anastasia Mironova to the positions of CFO, Secretary and Treasurer of the Company. "We are excited to welcome Anastasia to ARI, where she will bring a deep knowledge and understanding of our industry after spending more than 15 years in public accounting, focused on the commercial real estate finance sector," said Stuart Rothstein, CEO and President of the company. Prior to Mironova's start, Rothstein will serve as interim CFO, Secretary and Treasurer from the period in between the departure of Jai Agarwal at the end of January and Mironova's start date, which is expected to be at the beginning of the second quarter of 2021.
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SCPS | Hot Stocks09:14 EST Scopus BioPharma provides update following annual meeting of stockholders - Scopus BioPharma announced that it has filed an amendment to the Current Report on Form 8-K that was filed by the Company on December 27, 2021 with the U.S. Securities and Exchange Commission disclosing the certified voting results of the Annual Meeting of Stockholders. In addition, Scopus announced that three Scopus directors are challenging the results of the Annual Meeting as Morris Laster, M.D. and his three daughters may only own - and have been entitled to vote - 6,000 shares, less than 0.10% of their purported ownership position. Joshua Lamstein, Chairman of Scopus, stated, "The Company would like to thank its stockholders for their support at the Annual Meeting. The combination of the Lasters' own sworn statements in legal proceedings and the litigation by an affiliate of HCFP have called into question the Lasters' purported ownership position, including whether the Lasters ever owned any of the Disputed Shares, and the validity of the results of the Annual Meeting. The Company is committed to doing everything in its power to protect the interests of its actual stockholders from the nefarious and self-interested actions of the Lasters, whose only holding in Scopus may turn out to be 6,000 shares."
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CDMO | Hot Stocks09:12 EST Avid announces official opening of second downstream processing suite - Avid Bioservices announced the official opening of the second downstream processing suite within the company's existing Myford North facility. This new downstream processing suite was constructed as the first phase of the company's two-part Myford facility expansion. Avid has completed its validation of equipment and is now actively scheduling new business into the suite. The second phase of Avid's Myford facility expansion, for which construction has been initiated, is designed to further expand capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites within Myford South. Combined, the company estimates that the first and second phases of its Myford expansion will result in a total revenue generating capacity of up to approximately $270 million for the mammalian cell business annually. Avid also recently announced plans for a strategic expansion into the cell and gene therapy market through the construction of a world-class, purpose-built 53,000 square foot viral vector development and CGMP manufacturing facility. It is anticipated that total annual revenue generating capacity will increase to approximately $350 million with the addition of the viral vector business.
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UPLD | Hot Stocks09:11 EST Upland Software acquires Objectif Lune for $29M - Upland Software announced that it has acquired Objectif Lune, an enterprise software company in document composition and business communication automation. The purchase price paid for Objectif Lune and related entities was $29M in cash at closing, paid out of cash on hand, and a $5.3M cash holdback payable in twelve months. Upland expects the acquisition to generate annual revenue of at least $13M, including at least $12M of recurring revenue, and will be subject to reductions for deferred revenue discount as a result of GAAP purchase accounting currently estimated at $4M for the remainder of 2022 and $1M for 2023. The price paid for the acquisition is within Upland's target range of 5-8x pro forma adjusted EBITDA and it is expected that Objectif Lune will generate at least $5.2M in adjusted EBITDA annually once fully integrated. The acquisition will be immediately accretive to Upland's adjusted EBITDA per share contributing at least $300,000 of adjusted EBITDA in the quarter ended March 31 and at least $2.6M of adjusted EBITDA for the full year 2022 ramping up quarterly as the acquisition is integrated into model across the calendar year.
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VERU | Hot Stocks09:11 EST Veru announces FDA grant of fast track designation for enobosarm - Veru announced that the U.S. Food and Drug Administration has granted Fast Track designation to the Phase 3 registration program for the investigation of enobosarm, a selective androgen receptor targeting agonist, for the treatment of androgen receptor positive, estrogen receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have shown previous disease progression on a nonsteroidal AI, fulvestrant, and CDK 4/6 inhibitor therapy, and who have AR% nuclei staining greater than or equal to40% in breast cancer tissue. "We are very pleased that enobosarm has received Fast Track designation from the FDA, a distinction that underscores the urgent need for new, novel, targeted therapies for this important patient population suffering from this aggressive disease," said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc. "We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation."
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FDMT | Hot Stocks09:10 EST 4D Molecular announcse FDA fast track designation granted to 4D-125 - 4D Molecular Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track Designation for 4D-125 for treatment of patients with inherited retinal dystrophies due to defects in the RPGR gene, including X-linked Retinitis Pigmentosa. 4D-125 is a targeted and evolved R100-based product candidate, which was invented at 4DMT for efficient intravitreal delivery, and is designed to deliver a functional copy of the RPGR gene to photoreceptors in the retina.
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CPRX | Hot Stocks09:10 EST Catalyst Pharmaceuticals announces court of appeals denial of Jacobus petition - Catalyst Pharmaceuticals reported that the 11th Circuit Court of Appeals has denied Jacobus Pharmaceutical Company Inc.'s petition for rehearing of the 11th Circuit's prior ruling to overturn the U.S. Food and Drug Administration approval of Ruzurgi for pediatric patients with Lambert-Eaton myasthenic syndrome based on the orphan drug exclusivity of FIRDAPSE. Catalyst expects that the mandate to the District Court with instructions to enter summary judgment for Catalyst will be issued in the near future.
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ENJY | Hot Stocks09:09 EST Enjoy Technology appoints Vineet Gambhir as Chief People Officer - Enjoy Technology announced the appointment of Vineet Gambhir as Chief People Officer, effective January 7. Gambhir is an experienced leader in people development for high-growth businesses, with more than 20 years of human resources experience at transformative technology companies. As Chief People Officer, Mr. Gambhir will be responsible for overseeing the Company's people function and driving Enjoy's human capital strategy. He will lead Enjoy's strategic initiative to enhance its recruiting, onboarding and training processes as the Company scales its talent acquisition and development programs on a global basis to support its growth. Mr. Gambhir will join Enjoy's Enterprise Leadership Team and will report directly to CEO Ron Johnson.
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DZSI | Hot Stocks09:09 EST DZS added 105 new customers, 29 new broadband solutions in 2021 - DZS announced a summary of strategic growth milestones achieved in 2021, including the addition of 105 new customers across the Americas, Asia and Europe/Middle-East/Africa, EMEA, as well as dozens of active fixed and mobile technology proof of concepts, POCs, and customer trials around the world. DZS introduced 29 new technology solutions in 2021 spanning its Broadband Connectivity, Connected Home & Business, Mobile & Optical Edge, and Network & Experience Software platforms. "2021 was a transformational year for DZS as we successfully completed our people, product and system rationalization, consolidated & streamlined manufacturing, improved our strategic alignment with valued technology partners and began to capitalize on the global communications infrastructure upgrade cycle that we expect will continue throughout 2022," said Charlie Vogt, President and CEO, DZS. "We are in the midst of a super-cycle, spurred by pandemic-related appreciation of hyper-connectivity, geopolitical security concerns, and unparalleled global stimulus programs. DZS is better positioned than ever to meet and exceed the requirements of our extensive customer base as well as the numerous service provider targets that we are pursuing.
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TMUS... | Hot Stocks09:08 EST T-Mobile acquires Octopus Interactive, terms undisclosed - T-Mobile (TMUS) announced the acquisition of Octopus Interactive, a network of interactive video screens inside Uber (UBER) and Lyft (LYFT) vehicles. Octopus Interactive helps brands reach audiences through video ads presented on screens inside rideshare vehicles. Octopus's rideshare network enables brands to execute geotargeted campaigns across a range of engaged consumers.
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AGRX | Hot Stocks09:08 EST Agile Therapeutics, Afaxys partner to expand access to Twirla system - Agile Therapeutics announced a new alliance with Afaxys Pharma, LLC to promote Twirla transdermal system. Every year, more than 31 million Americans rely on community and public health centers to get essential care. This agreement expands access of Twirla in the U.S. family planning community and for the patients who rely on healthcare in this setting. As a trusted expert in community and public health, Afaxys is a leading provider of innovative contraceptive options, which will now include Twirla, an effective, low-dose contraceptive option in a non-daily, non-invasive patch.
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DNLI... | Hot Stocks09:08 EST Denali Therapeutics announces program progress, expected milestones - Denali Therapeutics (DNLI) announced program progress and expected milestones for 2022. Denali's 2022 Outlook: Expected progress and key milestones in 2022 across Denali's therapeutic portfolio are summarized below. DNL310: Phase 2/3 trial for MPS II to begin patient dosing in 1H 2022. BIIB122/DNL151: Late-stage trials in Parkinson's disease. Denali and Biogen (BIIB) are collaborating to co-develop and co-commercialize Denali's small molecule inhibitors of leucine-rich repeat kinase 2 for Parkinson's disease. Based on the strength of the Phase 1/1b data, start-up activities are ongoing for two late-stage trials of BIIB122 in PD for which Biogen will lead operational execution. SAR443820/DNL788 and SAR443122/DNL758: Phase 2 trials in neurodegenerative and peripheral inflammatory diseases. Denali and Sanofi (SNY) are collaborating on the development of small molecules that inhibit receptor interacting serine/threonine protein kinase 1. Sanofi decided to initiate a Phase 2 trial named HIMALAYA, in participants with amyotrophic lateral sclerosis. DNL343: Phase 1b safety and biomarker data in ALS expected in mid 2022. DNL919: Advancing into first-in-human trials with safety and biomarker data expected in 2H 2022. DNL593: Advancing into first-in-human trials. Oligonucleotide TV: First nonhuman primate data further validates TV platform for brain delivery of oligonucleotides. DNL126: Announcing first preclinical biomarker data supporting development in MPS IIIA and further validating the Enzyme Transport Vehicle. Bispecific ATV:HER2: Expanding the TV platform with potential applications in oncology.
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JETMF | Hot Stocks09:07 EST Global Crossing Airlines projects strong demand in 1Q22 - Global Crossing Airlines Group provided an update on its operations for the fourth quarter of 2021 and a preview of Q1 2022. "Q4 was an excellent quarter with over 1,400 block hours sold (of which half was in December) versus 378 block hours in Q3 2021. Our government business remained strong, and we added several new clients with football bowl game flying and continued expansion of our Havana flying. We continue to be very excited about the enthusiasm for our product offering and our growing portfolio of customers. Our operations during the fourth quarter again demonstrated the validity of our business case," said Ed Wegel, Chair and CEO of GlobalX. Looking ahead, GlobalX projects strong demand and increased block hours in the first quarter of 2022. In addition to the delivery of two additional passenger aircraft in the first quarter, GlobalX's first two A321 freighters will enter conversion in January and February, on time for a Q3 delivery. In the fourth quarter of 2021, GlobalX sold 85% of its available capacity and expects to continue to sell capacity at that rate in 2022. Expected capacity in Q1 2022 will increase by 41% over Q4 2021 and expected capacity in Q4 2022 is projected to be 2.3 times greater than available capacity in Q4 2021. Commenting on the results, Mr. Wegel stated: "Our growth continues, and we are being offered additional aircraft at very advantageous lease rates and terms. Our business case remains strong, and we will start our cargo certification with the FAA this quarter with converted A321 freighters being delivered in the third quarter of 2022." As a reminder, there will be a Zoom webinar today at 2:00PM Eastern Time with Management to discuss these results and more.
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WH | Hot Stocks09:06 EST Wyndham Hotels & Resorts enters Poland - Wyndham Hotels & Resorts continues to expand its global footprint with its entry into Poland with the 205-room upscale Wyndham Wroclaw Old Town. Managed by Mogotel Hotel Group, a leading hotel operator in the Baltics, the property is expected to open early next month and will be located in the heart of Wroclaw's city center.
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ALLO | Hot Stocks09:06 EST Allogene announces removal of FDA clinical hold across AlloCAR T trials - Allogene Therapeutics announced that the U.S. Food and Drug Administration has removed the clinical hold on all of the Company's AlloCAR T clinical trials. Allogene previously announced on October 7, 2021 that the FDA had placed a hold on all five of the Company's AlloCAR T clinical trials based on a report of a chromosomal abnormality detected post-AlloCAR T administration in a single patient treated with ALLO-501A in the ALPHA2 study. Investigations concluded that the chromosomal abnormality was unrelated to TALEN gene editing or Allogene's manufacturing process and had no clinical significance. The abnormality was not detected in any manufactured AlloCAR T product or in any other patient treated with the same ALLO-501A lot. The abnormality occurred in the patient after the cell product was administered. It involved regions of the T cell receptor and immunoglobulin genes known to undergo rearrangement as part of the T cell or B cell maturation process. Allogene will be working with clinical trial investigators to resume study activities across AlloCAR T development programs as quickly as possible. Pending final discussions with the FDA, the Company also plans to initiate its pivotal Phase 2 trial of ALLO-501A in relapsed/refractory Large B Cell Lymphoma mid-year 2022.
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MDWT | Hot Stocks09:05 EST Midwest Holding announces strategic asset management initiative with ORIX Corp. - Midwest Holding announced the closing of a majority ownership sale of a consolidated reinsurance facility to a subsidiary of ORIX Corporation. Under the terms of the agreement, a subsidiary of ORIX USA purchased approximately 70% of Seneca Incorporated Cell, LLC 2020-01, a Midwest consolidated reinsurance cell. Midwest established SRC1 in early 2020 as the first reinsurance cell of Seneca Re, a Vermont domiciled captive reinsurance company. SRC1 has reinsured premium from its sister insurance company and Midwest subsidiary, American Life & Security Corp. ORIX Advisers, LLC, another subsidiary of ORIX USA, will be the manager of the assets underlying SRC1's reinsurance obligations going forward, replacing Midwest's asset management arm, 1505 Capital. Midwest will report the transaction in its 2021 financial statements. The transaction closed on December 30, 2021. In addition, Midwest has also established a new warehouse vehicle, SRC3, to be available for reinsurance transactions.
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PETS | Hot Stocks09:05 EST PetMed Express appoints Mark Moseley as CTO, Dan Pingree as CMO - PetMed Express announced the addition of three new executives to the company. These key hires are an integral part of PetMeds digital transformation, with each new leader providing a unique skill set to help accelerate growth in the Company's e-commerce business. PetMeds' newest executive hires: Mark Moseley, Chief Technology and Information Officer: Mark joins PetMeds after a successful career at language-learning leader Rosetta Stone, where he spent 17 years driving every aspect of the company's technology and operations. Dan Pingree, Chief Marketing Officer: Dan has a diverse set of digital retailing experiences, including seven years as the Chief Marketing Officer at Moosejaw Mountaineering. Jacqueline Smith, Vice President of People: Jacqueline was previously Vice President of HR at Anju Software, leading the company's global human resources operations.
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MDGL BMY | Hot Stocks09:04 EST Madrigal appoints Dominic Labriola as chief data, analytics officer - Madrigal Pharmaceuticals announced that Dr. Dominic Labriola has joined Madrigal as Senior Vice President and Chief Data and Analytics Officer. Dr. Labriola spent more than 20 years at Bristol Myers Squibb as Head of Global Biometric Sciences where he was responsible for the team overseeing the company's NASH program among many other programs.
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XELA | Hot Stocks09:03 EST Exela Technologies announces DMR, DrySign growth in Q4 - Exela Technologies announced that its Digital Mailroom, DMR, and DrySign offerings within the Digital Assets Group, DAG, delivered another strong quarter of new customers and users in the fourth quarter of 2021. DMR achieved customer growth of 44% while DrySign user growth reached 135% against prior quarter. "DrySign had a particularly strong quarter as the uptake in SMBs and individual users accelerated to exceed internal estimates," the company said. Growth also accelerated across new geographies and the company is positioned for further expansion into the two largest markets in the EU, France and Germany, this quarter. During Q4 2021, Exela launched Remote Notarization, an online notarization solution. While RON works as a standalone product, it also integrates with DMR and DrySign. The Company continues to onboard notaries daily for RON. "We are very encouraged by the growth trends in our digital assets group. Enterprise and SMB customers alike continue to embrace DMR and DrySign as the world continues to adapt to a highly remote, online way of operating. We look forward to seeing the benefit of network effects as user growth continues to accelerate," said Exela's president, Suresh Yannamani.
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ME | Hot Stocks09:02 EST 23andMe receives FDA clearance for direct-to-consumer genetic test - 23andMe Holding received FDA clearance for a genetic health risk report on a hereditary prostate cancer marker. This is the Company's third cancer risk report clearance, following the FDA's prior authorization for 23andMe's BRCA1/BRCA2 Genetic Health Risk report and its clearance for MUTYH-Associated Polyposis, a hereditary colorectal cancer syndrome. These two reports along with the new Hereditary Prostate Cancer report have been included by the FDA in a single "Cancer Predisposition Risk Assessment System" regulation. These three 23andMe reports are the only direct-to-consumer genetic health risk reports for inherited cancers that have been authorized by the FDA for use without prescription.
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EPC WMT | Hot Stocks09:02 EST Edgewell Personal Care's Billie Inc. to launch at Walmart locations - Billie Inc. announces it will launch at Walmart (WMT) locations nationwide, the first retail destination for the brand. Billie's best-selling and award-winning shave products are available on Walmart.com and rolling out to over 4,000 U.S. Walmart stores in February. Walmart customers will be able to purchase a range of Billie's products, including their hero product, the Billie Starter Kit, that has received over ten thousand five-star reviews online, quickly building its reputation as "the internet's favorite razor", and a new addition to the product line: Lavender Whipped Shaving Cream. Billie is owned by Edgewell Personal Care Company (EPC).
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NMRD | Hot Stocks09:01 EST Nemaura Medical appoints Arash Ghadar to COO - Nemaura Medical announces the appointment of Dr. Arash Ghadar as Chief Operating Officer. Prior to joining Nemaura, Dr. Ghadar spent a decade as the Technical Director of Datalink Electronics in Loughborough, England where he managed the design team as an autonomous entity within Datalink.
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GBT | Hot Stocks09:00 EST Global Blood Therapeutics announces availability of Oxbryta tablets - Global Blood Therapeutics announced Oxbryta tablets for oral suspension, a new dispersible, once-daily tablet dosage form recently approved by the U.S. Food and Drug Administration, is now available through GBT's specialty pharmacy partner network in the United States. On December 17, 2021, the FDA approved Oxbryta tablets for the treatment of sickle cell disease in children ages 4 to less than 12 years - expanding the previously approved use of Oxbryta to treat SCD in patients ages 12 years and older in the U.S. The FDA also approved Oxbryta tablets for oral suspension, the new dispersible tablet dosage form suitable for patients ages 4 to less than 12 years. Oxbryta is the first and only approved medicine that directly targets sickle hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD. Oxbryta is now available by prescription in two dosage forms for patients 4 years and older based on the patient's age, weight, and ability to swallow tablets: 500 mg tablets and 300 mg tablets for oral suspension. The 300 mg dispersible tablets for oral suspension are available in bottles of 60 and 90 tablets. The dispersible tablets include grape flavoring and are intended to be dispersed in room-temperature clear drinks for ease of swallowing making Oxbryta easier to take for patients who have difficulty swallowing whole tablets, particularly younger children.
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FATE | Hot Stocks08:59 EST Fate Therapeutics announces FDA clearance for FT536 - Fate Therapeutics announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug application for FT536, an off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor NK cell product candidate. FT536 is derived from a clonal master induced pluripotent stem cell line engineered with four functional elements, including a novel CAR that uniquely targets the alpha3 domain of the major histocompatibility complex class I related proteins A and B. MICA and MICB are stress proteins that are expressed at high levels on many solid tumors. The Company plans to initiate clinical investigation of FT536 as a monotherapy and in combination with tumor-targeting monoclonal antibody therapy for the treatment of multiple solid tumor indications. FT536 also incorporates a novel high-affinity 158V, non-cleavable CD16 Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; an IL-15 receptor fusion that augments NK cell activity; and the deletion of the CD38 gene, which promotes persistence and function in high oxidative stress environments such as the suppressive tumor microenvironment. The multi-center Phase 1 clinical trial of FT536 is designed to determine the maximum tolerated dose of FT536 and assess its safety and clinical activity as monotherapy and in combination with one of an array of five monoclonal antibodies for the treatment of advanced solid tumors. Eligible tumor types include advanced non-small cell lung cancer, colorectal cancer, head and neck cancer, gastric cancer, breast cancer, ovarian cancer, and pancreatic cancer. The Phase 1 clinical protocol allows for administration of FT536 initially in up to two, 30-day cycles, with each cycle consisting of three days of conditioning chemotherapy and three weekly doses of FT536. Patients with clinical benefit may be re-treated with up to two additional cycles. Furthermore, for those patients that achieve initial clinical response, additional treatment with FT536 may be administered following disease progression. The off-the-shelf treatment regimen is designed to be administered in the outpatient setting. The expression of MICA and MICB proteins, which is induced by cellular stress, damage or transformation, has been reported for many solid tumor types. Cytotoxic lymphocytes, such as NK cells and CD8+ T cells, can recognize and bind the membrane-distal alpha1 and alpha2 domains of MICA/B, activating a potent cytotoxic response. However, cancer cells frequently evade immune cell recognition by proteolytic shedding of the alpha1 and alpha2 domains of MICA/B. A recent publication in Science (DOI:10.1126/science.aao0505) by Kai W. Wucherpfennig, M.D., Ph.D., Chair of the Department of Cancer Immunology and Virology at the Dana-Farber Cancer Institute and co-leader of the Cancer Immunology Program at Dana-Farber / Harvard Cancer Center, demonstrated that antibody targeting of the MICA/B alpha3 domains specifically prevents MICA/B shedding and restores NK cell-mediated immunity. Additionally, in a more recent publication in Cancer Immunology Research, Dr. Wucherpfennig also demonstrated that cancers with B2M and JAK1 inactivating mutations resulting in loss of MHC Class I expression can be effectively targeted with MICA/B alpha3 domain-specific antibodies to restore NK cell-mediated immunity against solid tumors resistant to cytotoxic T cells. The Company's FT536 program is supported by an exclusive license from the Dana-Farber Cancer Institute to intellectual property covering novel antibody fragments binding MICA/B for iPSC-derived cellular therapeutics.
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BNGO | Hot Stocks08:58 EST Bionano Genomics announces publication of interim readout from trial on OGM - Bionano Genomics announced the publication of the first readout from the ongoing clinical trial designed to support establishing optical genome mapping, OGM, as part of standard of care, SOC, in diagnosis of genetic disease for postnatal patients. This publication reports on the postnatal genetic disease diagnostic arm of Bionano's study to evaluate OGM as an alternative to SOC workflows in four key clinical areas: prenatal and postnatal genetic diseases, hematologic malignancies and solid tumors. Study Design: The study is an Institutional Review Board-approved, multicenter, double-blinded trial with 202 clinical research subjects analyzed in a total of 331 sample runs. All samples had been previously tested with traditional methods like karyotyping, fluorescence in situ hybridization and chromosomal microarray. The samples were from cases with a genetic diagnosis, cases without a genetic diagnosis and controls. Key Findings: This publication describes OGM performance metrics like first pass success rate and reproducibility from site-to-site, operator-to-operator and run-to-run for the first time ever and for the largest number of samples investigated with OGM to date. Key findings for the technical endpoints were reported as follows: Concordance with SOC - 97.7%; Partially concordant with SOC - 2.3%; Concordance with SOC for pathogenic variant calls - 100%; Concordance with CMA - 100%; First-pass success rate for OGM - 94%; Reproducibility of analytical QC from site-to-site - 98.8%; and Reproducibility of pathogenic variant calls from site-to-site - 100%. Key Takeaways: The authors concluded that a single approach, like OGM, can allow genetic laboratories to provide rapid results with a cost-effective solution, which can benefit both the lab and the affected individuals.
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MDXG | Hot Stocks08:55 EST MiMedx outlines key strategic milestones for 2022 - Achieve annual growth target across the Company's vibrant commercial business: Expand the Company's international footprint with the initial launch of EPIFIX in Japan; Commence Phase 3 KOA program, with two clinical trials; Implement rigorous Current Good Manufacturing Practice standards throughout entire supply chain as a key market differentiator; Continue to advance the scientific body of evidence substantiating clinical efficacy, economic viability and underlying mechanism of action for our PURION processed placental tissue platform through additional peer-reviewed publications, including rigorous scientific research and clinical studies; Launch two new, organic products in the U.S.: AMNIOEFFECT and Placental Collagen Matrix, facilitating expansion into additional areas of significant unmet clinical need.
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ENSC | Hot Stocks08:55 EST Ensysce Biosciences announces first cohort dosing in BE study of TAAP opioid - Ensysce Biosciences announced the initiation and first dosing in the Bioequivalence, BE, trial of the novel Trypsin Activated Abuse Protected, TAAP, Opioid, PF614. The BE study follows the successful completion of the multi-ascending twice daily dosing study of PF614 and will compare PF614 versus OxyContin in subjects in both fasted and fed states. This data will be critical to understand future prescribing criteria for PF614. If successful, upon completion of the BE study the Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval. This pathway allows reference to available safety and clinical data from an approved product, and the BE data established by this study will move PF614 closer to registration. Commenting on the Company's progress, Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, stated, "As we enter 2022 with strong progress across our clinical stage pipeline, we are looking forward to the data from this BE study in the second quarter of the year to position PF614 as our first commercial candidate. We believe that we have the foundation in place to realize our mission of bringing a unique pipeline of products onto the market and helping the millions who experience severe pain."
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CXW | Hot Stocks08:54 EST CoreCivic awarded contract with the State of Arizon at La Palma - CoreCivic announced that it has been awarded a new contract with the State of Arizona for up to 2,706 adult male inmates on behalf of the Arizona Department of Corrections, Rehabilitation & Reentry at the Company's 3,060-bed La Palma Correctional Center in Eloy, Arizona. The new management contract has an initial term of five years, with one extension option for up to five years thereafter upon mutual agreement. The Company and ADCRR are currently working on a ramp plan that is expected to begin late in the first or early in the second quarter of 2022. Upon full utilization of the new contract the Company expects to generate approximately $75 million to $85 million in annualized revenue.
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EYPT | Hot Stocks08:53 EST EyePoint Pharmaceuticals announces 2022 clinical plans - EyePoint Pharmaceuticals announced its 2022 clinical pipeline plans and highlighted recent corporate achievements driven by its lead pipeline candidate, EYP-1901, a potential six-month intravitreal treatment targeting wet age-related macular degeneration, wet AMD. Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals said, "As we look ahead to 2022, EyePoint is focused on pipeline growth and expansion, with the ultimate goal of improving the lives of patients with serious eye disorders and bringing innovative products to patients in the United States and around the world. We look forward to continued advancement of our programs through clinical development, while also positioning our commercial franchises, DEXYCU and YUTIQ, to breakeven in 2022." 2022 Clinical Plans: Updated eight-month data from the Phase 1 DAVIO study of EYP-1901 for wet AMD has 7 of 17 patients out to eight months rescue free and continued positive safety profile. Initiate a randomized, controlled Phase 2 study of EYP-1901 for wet AMD in Q3 2022. Initiate a randomized, controlled Phase 2 study of EYP-1901 in diabetic retinopathy in 2H 2022. Continue investment in clinical and R&D organization to support pipeline expansion and growth. Corporate: Q4 2021 customer demand of approximately 650 units of YUTIQ and 13,800 units for DEXYCU, compared to approximately 560 units and 13,100 units, respectively for Q3 2021. Approximately $210M in cash and investments at December 31, 2021 including over $230 million in proceeds from two successful follow-on offerings during the year.
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CTSDF | Hot Stocks08:53 EST Converge Technology acquires Paragon Development Systems - Converge Technology Solutions is pleased to announce it has acquired PDS Holding Company, a Delaware corporation, and its wholly-owned subsidiaries, including Paragon Development Systems, a Wisconsin-based organization focused on fueling digital transformation. Converge acquired PDS from Mason Wells, a private equity firm based in Milwaukee, Wisconsin. With incredible expertise supporting Enterprise Solutions, Managed Services, and true Digital Workplace platforms, Paragon Development Systems works synergistically to leverage the strength of its solution architects and engineering teams to design the right solutions to drive successful strategic outcomes. PDS offers solutions ranging from cloud and security to servers and infrastructure to virtualized work environments and remote work. PDS serves clients in three distinct markets (healthcare, public sector, and corporate), advising and assisting with unique information technology needs in upgrading and modernizing core business technology infrastructure on the continuing journey of innovation and digital transformation.
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SLDB | Hot Stocks08:51 EST Solid Biosciences outlines strategic priorities for 2022 - Solid Biosciences provided an update on its 2022 strategic priorities and other business initiatives. Highlights from the presentation to be given at the J.P. Morgan Healthcare Conference include: SGT-001: Following implementation of the updated risk mitigation strategy, the Company dosed a 9th patient in the IGNITE DMD Phase I/II clinical trial for SGT-001 in November 2021 using the company's second-generation manufacturing process. Solid plans to continue dosing patients in IGNITE DMD in 2022 as well as share additional expression, functional, pulmonary and patient reported outcomes data from the trial in the first half of this year. SGT-003: Solid will present additional data on SGT-003 demonstrating increased protein expression and more targeted biodistribution compared to AAV9. The company also intends to initiate IND-enabling studies in 2022 to support an IND submission in early 2023. Platform Technologies: The company will introduce and present data on development programs for two Platform Technologies, Novel Capsids and Dual Gene Expression. These programs are part of the company's ongoing research efforts to develop innovative technologies that Solid believes may hold potential to translate into meaningful treatments and drive the company's future pipeline expansion. The company is also announcing that the Chair of its Board of Directors, Ian Smith, has been named Executive Chair.
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AMED | Hot Stocks08:49 EST Amedisys announces Kusserow will retire as CEO, appoints Gerard as successor - Amedisys announced that Chairman and Chief Executive Officer, CEO, Paul Kusserow will retire as CEO on April 15th, 2022. Upon his retirement as CEO, Kusserow will continue to serve as Chairman of the Board of Directors, and current President and Chief Operating Officer , Chris Gerard, will assume the role of President and CEO and join the Board of Directors following the succession planning process that began in early 2021.
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RARE | Hot Stocks08:48 EST Ultragenyx reports cash balance of $1B as of Dec. 31 - Cash, cash equivalents, and available-for-sale investments were approximately $1.0 billion as of December 31, 2021.
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ADN | Hot Stocks08:48 EST Advent Technologies enters distribution, service agreement with Calscan - Advent Technologies announced it has signed a distribution and service agreement with Calscan Solutions, an Alberta, Canada industrial service company focused in the oil field industry with a number of products, including methane emissions mitigation instrumentation & controls, as well as services.
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ASND | Hot Stocks08:47 EST Ascendis provides update on Vision 3x3 roadmap, planned 2022 milestones - Ascendis Pharma announced that the Company will today provide an update on its Vision 3x3 and planned 2022 key milestones at the 40th Annual J.P. Morgan Healthcare Conference. Pipeline Updates: TransCon hGH: In mid-October, the Company commercially launched in the U.S. TransCon hGH under the brand name SKYTROFA. During the fourth quarter, 369 SKYTROFA prescriptions were written by 139 targeted prescribers, which includes 42% repeat prescribers. During the second quarter of 2022, the Company plans to submit a protocol to the FDA for TransCon hGH in Turner Syndrome subjects. Ascendis is targeting completion of enrollment in foresiGHt, a global Phase 3 trial evaluating the safety and efficacy of TransCon hGH in adult patients with growth hormone deficiency during the second quarter of 2022. TransCon PTH: During the first quarter of 2022, top-line results are expected from PaTHway trial in North America and Europe. If the Phase 3 PaTHway Trial results are positive, Ascendis plans to submit a New Drug Application to the FDA in the third quarter of 2022 followed by a MAA submission to the EMA in the fourth quarter of 2022. Top-line results from PaTHway Japan, a single-arm Phase 3 trial of TransCon PTH in a minimum of 12-Japanese subjects with HP are expected in the third quarter of 2022. Initiation of a pediatric HP program is planned for the fourth quarter of 2022. TransCon CNP: Top-line data from the ACcomplisH Trial, a Phase 2 randomized, double-blind, placebo-controlled clinical trial in North America, Europe, and Oceania in subjects with achondroplasia are expected in the fourth quarter of 2022. During the second quarter of 2022, the Company plans to file an Investigational New Drug application or similar for the ACcomplisH Infants Trial in subjects with achondroplasia. TransCon TLR7/8 Agonist: Enrollment continues in transcendIT-101. Top-line data from monotherapy and combo-therapy dose escalation expected in the third quarter of 2022. TransCon IL-2 beta/gamma: Top-line monotherapy data from the IL-eliee Trial are expected in the fourth quarter of 2022 and the company expects to dose the first patient in the combo-therapy and dose escalation arm of the IL-eliee Trial in the first quarter of 2022. TransCon TLR7/8 Agonist and TransCon IL-2 beta/gamma Combinations: During the fourth quarter of 2022, the Company plans to submit an IND or similar for Phase 2 cohort expansion for TransCon TLR7/8 Agonist and TransCon IL-2 beta/gamma.
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IOVA | Hot Stocks08:46 EST Iovance appoints Raj Puri as EVP, regulatory strategy, translational medicine - Iovance Biotherapeutics announced that Raj K. Puri, M.D., Ph.D., will join the Company as Executive Vice President, Regulatory Strategy and Translational Medicine. Dr. Puri will begin his employment with the Company toward the end of the first quarter of 2022. For more than 19 years, Dr. Puri has served as the director of the Division of Cellular and Gene Therapies in the Office of Tissues and Advanced Therapies at the United States Food and Drug Administration in its Center for Biologics Evaluation and Research. He is also a Chief of Tumor Vaccines and Biotechnology Branch within DCGT.
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SACH | Hot Stocks08:45 EST Sachem Capital appoints Nicholas Marcello as VP, finance and operations - Sachem Capital announces the promotion of Nicholas Marcello to Vice President, Finance and Operations, effective immediately, in connection with the planned retirement of Peter Cuozzo as Executive Vice President and Chief Operating Officer, effective January 14, 2022. Mr. Marcello joined Sachem Capital Corp. in September 2020 as Director of Finance and will assume a leadership role in business operations. He will continue to have oversight of the company's financial reporting, capital markets activities, tax compliance, and investments
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ORIC | Hot Stocks08:41 EST Oric Pharmaceuticals expects cash to fund operations into first half of 2024 - As of December 31, 2021, cash, cash equivalents and investments totaled $280.8M.
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NVAX | Hot Stocks08:41 EST Novavax, SII file for EUA of Novavax' COVID-19 vaccine in South Africa - Novavax and Serum Institute of India announced a regulatory submission to the South African Health Products Regulatory Agency for emergency use authorization of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. If authorized, the vaccine, known as NVX-CoV2373, will be manufactured by and commercialized by SII in South Africa under the brand name Covovax.
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VTSI | Hot Stocks08:40 EST VirTra receives orders from two foreign countries totaling $2.7M - VirTra has received two foreign country orders totaling $2.7M: one for $1.6M and another for $1.1M. Both orders are for simulators, software, content and associated training tools. Both purchase orders include the delivery of multiple simulators, Threat-Fire real-world consequence devices, drop-in weapon recoil kits, and other integrated tools designed for enhanced realism needed for effective training. The orders include installation and training courses to facilitate the operation of each simulator and its accessories. The first order is planned to be delivered in early 2022 and the second order is expected to be delivered in spring 2022. Neither of these orders are related to the recent standing offer awarded to VirTra by the government of Canada.
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RUBY | Hot Stocks08:40 EST Rubius Therapeutics reports anticipated 2022 catalysts - "In 2021, Rubius Therapeutics demonstrated strong execution in advancing our clinical oncology pipeline and showing preclinical proof of concept of our tolerance induction approach in autoimmunity that could extend well beyond type 1 diabetes to other T cell-mediated diseases," said Pablo J. Cagnoni, M.D., president and chief executive officer, of Rubius Therapeutics. "With the initial clinical results from the Phase 1 clinical trial of RTX-240 in patients with advanced solid tumors reported in March 2021, we provided clinical validation of the RED PLATFORM and increased our likelihood of success across our entire oncology pipeline of Red Cell Therapeutics. With multiple data milestones on the horizon in 2022, we are on the cusp of potentially further validating the RED PLATFORM and benefiting an even greater number of patients." Anticipated 2022 Catalysts and Operational Objectives: Present additional clinical results from the Phase 1 arm of the RTX-240 Phase 1/2 clinical trial in advanced solid tumors and the Phase 1 arm in relapsed/refractory acute myeloid leukemia during the first quarter of 2022; Initiate RTX-240 Phase 2 expansion cohorts in select solid tumor types during the first quarter of 2022; Report initial clinical results from the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers during the second half of 2022; Present initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in combination with pembrolizumab in patients with advanced solid tumors during the second half of 2022; Scale to 200L bioreactors by mid-2022 to support potential pivotal trial and eventual commercialization.
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ORIC | Hot Stocks08:39 EST Oric Pharmaceuticals provides update, key upcoming milestones - ORIC Pharmaceuticals provided program updates and announced upcoming key milestones that are expected to substantially broaden and advance the company's clinical pipeline. Program Updates and Milestones: ORIC-101: Glucocorticoid Receptor Antagonist: The company expects to provide an update on two Phase 1b trials in the first half of 2022. ORIC-533: CD73 Inhibitor: Based on strong mechanistic rationale and compelling preclinical single agent activity in bone marrow cells from patients with multiple myeloma, the company has initiated a Phase 1b trial as a single agent in multiple myeloma and expects to report initial data in the first half of 2023. ORIC-114: EGFR/HER2 Inhibitor - The company expects to report initial Phase 1b data in the first half of 2023. ORIC-944: PRC2 Inhibitor - The company plans to pursue a single agent clinical development plan in metastatic prostate cancer and expects to report initial Phase 1b data in the first half of 2023. Anticipated Program Milestones: ORIC anticipates the following upcoming milestones: ORIC-101: Updates from two Phase 1b combination trials in 1H 2022; ORIC-533: Initial Phase 1b data in 1H 2023; ORIC-114: Initial Phase 1b data in 1H 2023; ORIC-944: Initial Phase 1b data in 1H 2023; and New program and/or indication to be announced in 2022.
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MYO | Hot Stocks08:39 EST Myomo updates reimbursement for its MyoPro device by large private payer - Myomo provided an update on reimbursement for its MyoPro device by a large private payer that was denying pre-authorized claims after delivery of devices to patients. For the three and nine months ended September 30 revenue from patients insured by this payer represented 32% and 30% of total revenues, respectively. As of today, approximately 90% of the claims that were denied with dates of service in September and October 2021 have been paid, either in whole or in part, and none of the appeals submitted to the payer have been denied. Although pre-authorized claims filed with dates of service after November 10, 2021 - the date on which the Company disclosed this issue - continue to be denied by this payer, Myomo's interactions with the payer lead the Company to believe that these post-service denials are an internal processing issue within the payer's operations, which the payer intends to resolve. This payer continues to pre-authorize new devices for patients. At present, the Company does not intend to change its revenue recognition practice as it relates to this payer; however, the Company cannot provide any assurance that future events will not change this determination for any revenues recorded in or subsequent to the fourth quarter of 2021 with respect to this payer
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MVST | Hot Stocks08:38 EST FPT, Microvast under hood of new IVECO BUS electric crossway - FPT Industrial, with its partner Microvast Holdings will provide the complete battery system for the new Crossway Low Entry city and intercity bus produced by IVECO BUS, also a brand of Iveco Group and a leading manufacturer of buses and coaches. The contract award was achieved based on the 2019 agreement that encompasses an industrial and commercial cooperation between Microvast and FPT Industrial, with the latter leading the development of mechanical and thermal integration and industrialisation of high-voltage battery packs for commercial vehicles. For the IVECO BUS Crossway Low Entry Electric, Microvast designed and FPT Industrial industrialised, validated, and certified a high energy density battery pack that ranges from 400 to 466 kWh, depending on operative mission requirements. This new generation battery pack will set an industry standard in terms of energy density and charging capacity and will provide the Crossway LE Electric with up to ten years of battery life. This marks an important step forward in a shared "electrification journey". The IVECO BUS Crossway LE Electric project complements that of the new IVECO e-Daily, which will be launched at the end of 2022. The new electric Daily will be equipped with a modular battery concept with 1 to 3 batteries ranging from 37 to 111 kWh, pioneering the cooperation between Microvast and FPT Industrial in this first application that aims to set the zero-emission standard in the cab-chassis segment.
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WE | Hot Stocks08:37 EST WeWork provides preliminary December sales results - WeWork announced preliminary sales results for December 2021. Preliminary consolidated gross desk sales were 66,000 in December 2021, up from 43,000 in October 2021 and 55,000 in November 2021. Preliminary consolidated new desk sales were 33,000 in December 2021, up from 25,000 in October 2021 and 30,000 in November 2021. Preliminary consolidated physical occupancy rate was 63% in December, a seven percentage point improvement from 56% physical occupancy at the end of Q3 2021. Preliminary All Access memberships increased to 45,000 in December 2021, an increase from 32,000 at the end of Q3 2021 and 41,000 in November 2021. These All Access memberships represent an additional six percentage points of occupancy.
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GILD MRK | Hot Stocks08:37 EST Gilead in trial pact with Merck to evaluate Trodelvy -Keytruda combo in NSCLC - Gilead Sciences (GILD) announced it has entered into two clinical trial collaboration and supply agreements with Merck (MRK) to evaluate the combination of Gilead's Trop-2 targeting antibody-drug conjugate, ADC, Trodelvy, sacituzumab govitecan-hziy, and Merck's anti-PD-1 therapy KEYTRUDA, pembrolizumab, in first-line metastatic non-small cell lung cancer NSCLC. As part of the collaboration, Merck will sponsor a global Phase 3 clinical trial of Trodelvy in combination with KEYTRUDA as a first-line treatment for patients with metastatic NSCLC. Additionally, the companies recently established an agreement whereby Gilead will sponsor a Phase 2 signal-seeking study evaluating combinations that include pembrolizumab in first-line NSCLC. "We're excited to broaden our clinical collaborations with Merck to investigate Trodelvy in combination with KEYTRUDA in another cancer where there is tremendous need for novel combinations to help improve patient outcomes," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "This partnership builds on our ambition of providing alternatives to traditional chemotherapy with Trodelvy containing regimens across some of the most difficult-to-treat cancers." These agreements follow a collaboration, established in October 2021, to investigate Trodelvy in combination with KEYTRUDA as first-line treatment for people with locally advanced or metastatic triple-negative breast cancer, TNBC. The use of Trodelvy for the treatment of NSCLC and the use of Trodelvy in combination with KEYTRUDA for any use is investigational, and the safety and efficacy for these uses have not been established or approved by regulatory agency globally.
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SAND | Hot Stocks08:36 EST Sandstorm Gold sold 67,500 attributable gold equivalent ounces in 2021 - Sandstorm Gold is pleased to report that the company sold approximately 67,500 attributable gold equivalent ounces and realized preliminary revenue of C$114.8M for the full 2021 year, both representing a record for the company. During the year, Sandstorm realized preliminary total sales, royalties, and income from other interests of C$120.7M. During the three months ended December 31, 2021, the company sold approximately 16,600 attributable gold equivalent ounces and realized preliminary revenue of C$29.8M. Preliminary cost of sales, excluding depletion for the three month period was C$3.7M resulting in cash operating margins of approximately $1,570 per attributable gold equivalent ounce.
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BNTX | Hot Stocks08:36 EST BioNTech, Crescendo Biologics announce global collaboration - BioNTech and Crescendo Biologics announced that they have entered a multi-target discovery collaboration to develop novel immunotherapies for the treatment of patients with cancer and other diseases. The initial term of the discovery collaboration is three years. Crescendo will contribute its platform to deliver fully human heavy-chain antibody domains against targets nominated by BioNTech. "Crescendo's platform provides excellent properties for exploiting novel targets and target combinations which we believe has great potential for the development of multi-specific mRNA and engineered cell-based therapies in a variety of disease areas," said Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We are excited to begin working with Crescendo to further strengthen and expand our multimodal immunotherapy portfolio and deliver breakthrough precision medicines for patients." Under the terms of the agreement, Crescendo will receive $40M upfront, including a cash payment and an equity investment from BioNTech, as well as research funding for the period of the collaboration. BioNTech will be responsible for global development and hold exclusive worldwide commercialization rights on any products arising from the collaboration. Crescendo will be eligible to receive development, regulatory and commercial milestones up to a total of more than $750M, in addition to tiered royalties on global net sales.
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SRZN | Hot Stocks08:35 EST Surrozen announces key 2022 milestones - Surrozen announced key development goals and acceleration of its research pipeline as the company transitions to a clinical-stage biotechnology company. Recent Highlights:Lead Product Candidates: SZN-1326 for Moderate to Severe Ulcerative Colitis and SZN-043 for Severe Alcoholic Hepatitis: SZN-1326 is the first development candidate designed using Surrozen's SWAP technology and targets the Wnt signaling pathway in the intestinal epithelium. In preclinical animal models of acute and chronic colitis, SZN-1326 has been shown to activate Wnt signaling in the intestine, stimulate intestinal epithelial regeneration, reduce inflammation and reduce disease activity. Surrozen is developing SZN-1326 for moderate to severe inflammatory bowel disease. SZN-043 is the first development candidate designed using Surrozen's SWEETS technology. In preclinical animal models of liver injury and fibrosis, SZN-043 has been shown to selectively activate Wnt signaling in the liver, stimulate hepatocyte proliferation and reduce fibrosis. Surrozen is developing SZN-043 for severe liver diseases, including severe alcoholic hepatitis. Following the recent completion of IND-enabling GLP toxicology studies, Surrozen expects to initiate Phase 1 clinical trials of both SZN-1326 and SZN-043 in healthy volunteers in the third quarter of 2022. Research Pipeline: SZN-413 for Retinopathies, Including Wet AMD and Diabetic Retinopathy: Fzd4-mediated Wnt signaling is known to play a critical role in retinal vascular integrity and function. Data with Fzd4-specific Surrozen Wnt modulating tool molecules has shown that selectively activating Wnt signaling can rescue a disease phenotype in a norrin knockout model. Surrozen recently nominated SZN-413, a mono Fzd4 bispecific antibody, as a development candidate for the treatment of retinal vascular associated diseases, including wet age-related macular degeneration and diabetic retinopathies. Recent data evaluating SZN-413 in preclinical models of retinopathy demonstrated: Stimulated Wnt signaling in retinal vascular endothelial cells; Increased tight junction protein expression in retinal vascular endothelial cells; Significantly reduced avascular area and pathological neovascular tuft formation in an oxygen-induced retinopathy mouse model; Lacrimal Gland; Tear-producing glands rely on Wnt signaling for maintenance of function. Restoration of gland function through activation of Wnt signaling is a potential therapeutic approach to treat dry eye, including dry eye associated with Sjogren's Disease. Preclinical data demonstrated that Surrozen Wnt-modulating molecules: Stimulated Wnt signaling in the lacrimal gland; Increased tear production within two days in a mouse IL-1a lacrimal gland injury model. Lung: Recent discoveries of Wnt-responsive progenitor cells in the lung suggest a potential role for Wnt in diseases such as idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease. Preclinical data demonstrated that Surrozen Wnt-modulating molecules: Activated Wnt signaling in the lung; Expands Alveolar AT2 cell organoids; Reduced injury and improved fibrosis in an acute bleomycin mouse model.
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BLBX | Hot Stocks08:35 EST Blacboxstocks announces $2.5M stock repurchase plan - Blackboxstocks announced that the company's board of directors has approved a stock repurchase program for up to $2.5M of the company's common stock. The repurchase plan will expire on December 31. The timing and actual number of shares repurchased will depend on a variety of factors including but not limited to share price, trading volume, general business and market conditions as well as other potential investment opportunities. The repurchase program will be executed consistent with the company's capital allocation strategy, which will continue to prioritize aggressive investments to grow the business.
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ENPH | Hot Stocks08:34 EST Enphase Energy expands battery storage in New York - Enphase Energy announced that Enphase installers in New York have seen increased deployments of the Enphase Energy System, powered by IQ Microinverters and IQ Batteries. "We want to give our customers unprecedented control over their home energy and offer them peace of mind when it's needed most," said Michael Lawton, CEO at Element Energy, an Enphase Gold installer. "The Enphase Energy System offers first-class monitoring, safety, reliability, and the option to grow with our customers as their needs change."
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CARA | Hot Stocks08:33 EST Cara says Difelikefalin Phase 3 trial meets primary, secondary endpoints - Cara Therapeutics announced that its licensing partner Maruishi Pharmaceutical Co., Ltd., and its sublicensee Kissei Pharmaceutical Co., Ltd., confirmed the primary endpoint was achieved in a Japanese Phase 3 clinical study of difelikefalin injection for the treatment of pruritus in hemodialysis patients. In the Phase 3 study, 178 patients were administered difelikefalin or placebo for 6 weeks followed by an open-label extension period of difelikefalin administration for 52 weeks. The primary endpoint, change in itch Numerical Rating Scale score, and the secondary endpoint, change in itching scores of Shiratori severity criteria, were significantly improved from baseline compared to the placebo group. Difelikefalin was well-tolerated. KORSUVA injection was approved by the U.S. Food and Drug Administration in August 2021 for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Cara's U.S. commercial partner Vifor Pharma is on track to launch KORSUVA injection in the U.S. early in the second quarter of 2022. In addition, the Marketing Authorization Application for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients is undergoing review with the European Medicines Agency.
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SABR | Hot Stocks08:33 EST Sabre, Aviatur announce new multi-year preferred GDS agreement - Sabre and Aviatur, Colombia's leading travel agency and one of the largest in Latin America, announced a new multi-year preferred GDS agreement to support the agency's growth plans, transform its business, and increase efficiencies. This new 11-year GDS agreement with Aviatur Travel Agency will help propel their future in the travel & tourism, technology and hospitality industries.
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SPTN | Hot Stocks08:33 EST SpartanNash appoints Amy McClellan as chief marketing officer - SpartanNash announced Amy McClellan has been promoted to senior VP and chief marketing officer, effective immediately. McClellan will lead the marketing function and report to SpartanNash president and CEO Tony Sarsam. McClellan joined SpartanNash in 2019 when the company acquired Martin's Super Markets.
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NLTX MRK | Hot Stocks08:32 EST Neoleukin Therapeutics announces clinical collaboration with Merck - Neoleukin Therapeutics announced a clinical trial collaboration and supply agreement with Merck. The agreement will allow for the evaluation of safety and efficacy of Neoleukin's NL-201, a de novo protein designed to mimic the therapeutic activity of natural cytokines IL-2 and IL-15, in combination with Merck's anti-PD-1 therapy KEYTRUDA in an ongoing Phase 1 trial. Neoleukin will evaluate NL-201 plus pembrolizumab as part of the company's ongoing Phase 1 trial in patients with advanced, relapsed or refractory solid tumors. Up to 132 patients will be enrolled in the combination arm of the study. The trial is assessing safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.
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CBZ | Hot Stocks08:32 EST CBIZ acquires Marks Paneth, terms not disclosed - CBIZ announced that it has acquired the non-attest assets of Marks Paneth LLP, effective January 1, 2022. Concurrent with this transaction, Mayer Hoffman McCann P.C., a national independent CPA firm that works closely with CBIZ, announced the acquisition of the attest assets of Marks Paneth LLP. The transaction is expected to add approximately $138M of revenue to CBIZ in 2022. Eliminating the impact of the transaction related costs and first year integration costs, the contribution to earnings per share in 2022 is expected to be approximately 10c, growing to a range of 20c-25c by 2025, after all remaining transition related integration costs are addressed. On a GAAP reported basis the transaction is expected to have minimal impact on earnings per share in 2022, but is expected to be significantly accretive after first year transaction and integration costs are incurred. Eliminating the impact of transaction costs and first year integration costs, EBITDA in 2022 is expected to be within a range of 11%-12% of revenue, growing to a range of 16%-18% of revenue by 2025.
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VATE | Hot Stocks08:31 EST INNOVATE Corp. announces launch of 21 newly constructed broadcast stations - INNOVATE announced that its Spectrum segment, HC2 Broadcasting Holdings has successfully completed the construction of 21 new broadcast stations, adding 12 new designated market areas to Broadcasting's already extensive coverage area. The 21 stations are now fully operational and on air. Broadcasting is a wholly owned subsidiary of INNOVATE Corp. Broadcasting operates an industry-leading portfolio of 248 broadcast stations in over 106 U.S. TV markets and Puerto Rico, including 34 of the top 35 markets. Broadcasting had previously announced plans to complete the construction of 24 stations, and remains on track, with timely completion of the remaining three stations expected by the end of the first quarter of 2022.
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CRNC NIO | Hot Stocks08:30 EST Cerence powers AI Assistant in Nio's ES8 - Cerence announced that NIO will deploy Cerence conversational AI in its ES8 full-size SUV as the carmaker expands to Norway.
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KNSA | Hot Stocks08:30 EST Kiniksa provides anticipated 2022 milestones - Kiniksa Pharmaceuticals provided a corporate update and announced anticipated milestones for 2022. Portfolio Update: ARCALYST: Kiniksa expects to provide full-year 2022 ARCALYST net revenue guidance with its fourth quarter and full-year 2021 financial results. Mavrilimumab: As previously reported, the Phase 3 portion of the Phase 2/3 trial of mavrilimumab in COVID-19-related acute respiratory distress syndrome did not meet its primary efficacy endpoint; Kiniksa continues to believe in the potential broad utility of mavrilimumab and is evaluating next steps for the molecule. Vixarelimab: Kiniksa expects data from the Phase 2b dose-ranging clinical trial of once-monthly subcutaneous vixarelimab in prurigo nodularis in the second half of 2022. KPL-404: Kiniksa is enrolling and dosing patients in a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to enable potential development in a spectrum of autoimmune diseases believed to be mediated by the CD40-CD154 pathway.
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KNSA | Hot Stocks08:29 EST Kiniksa expects cash to fund operations into 2024 - Kiniksa's year-end 2021 cash, cash equivalents and short-term investments of approximately $182M.
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SEER | Hot Stocks08:29 EST Seer announces broad commercial release of Proteograph product suite - Seer announced Broad Commercial Release of its Proteograph Product Suite and the launch of its Centers of Excellence program. The Proteograph Product Suite provides unprecedented access to the proteome in an unbiased way, and at a scale comparable to what next-generation sequencing has provided in genomics. The solution leverages proprietary engineered nanoparticles to create a first-of-its-kind product that enables unbiased, deep, and rapid proteomics at scale. Seer has already received multiple Broad Release orders for the Proteograph Product Suite.
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TARA | Hot Stocks08:28 EST Protara Therapeutics appoints Jathin Bandaria as CMO - Protara Therapeutics announced the appointment of Jathin Bandari, M.D., as Chief Medical Officer. Dr. Bandari is a practicing urologic oncologist, recently serving at the University of Rochester where he specialized in both minimally invasive urologic oncology and advanced open pelvic retroperitoneal cancer surgery, and where he maintains a faculty appointment. Dr. Bandari joined Protara in April 2020 as Vice President, Head of Clinical Development, and most recently was Interim Chief Medical Officer.
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PSN JBLU | Hot Stocks08:26 EST Parsons awarded $12M contract to support terminal development for JetBlue - Parsons (PSN) announced that the company was awarded a contract by new client JetBlue Airways (JBLU) to deliver program management services for the development of Terminal 5 at Fort Lauderdale/Hollywood International Airport, FLL. JetBlue Airways has been selected to manage the construction of Terminal 5 on behalf of the Broward County Aviation Department. The $12.6M program management contract will assist JetBlue in implementing the design and building of a new five-gate, $300M passenger terminal at FLL. "Fort Lauderdale/Hollywood International airport is one of the fastest-recovering U.S. airports, with passenger traffic approaching 2019 pre-pandemic levels. As we continue a return to air travel, it is critical for airports and airlines alike to prepare for passenger and service expansion," said Peter Torrellas, president, connected communities, for Parsons.
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AVCNF | Hot Stocks08:26 EST Avicanna appoints Stephen Kim as CLO, general counsel - Avicanna USA is pleased to announce the appointment of Stephen Kim as the Avicanna's Chief Legal Officer & General Counsel. Prior to joining Avicanna, Mr. Kim held various roles of progressive responsibility at global biotechnology and pharmaceutical companies including Bayer Inc., Celgene Corporation, and Indivior Inc., and also held roles as an associate with leading US and International law firms in New York City and Toronto.
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BLI | Hot Stocks08:24 EST Berkeley Lights, Aanika Biosciences announce partnership - Berkeley Lights announced a strategic partnership that will "enable faster identification of outbreak sources, reduce incidents of fresh produce contamination and minimize the impact of food borne illness related recalls," the company said. In this partnership, Aanika will use Berkeley Lights' screening service to identify and optimize functional, antimicrobial peptides capable of killing harmful bacteria. In addition, the Beacon Optofluidic Platform will be leveraged to find peptides that are toxic to bacteria to create a new antibacterial tag that will then be applied to their bacterial spore-based barcoding technology to protect the food supply chain.
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OMIC | Hot Stocks08:23 EST Singular Genomics partners with New England Biolabs - Singular Genomics Systems announced a partnership with New England Biolabs to validate its NEBNext kits, a product line for both DNA and RNA sample prep, with the G4 sequencing platform. High-quality, high-yield library preparation is a critical first step towards optimizing NGS workflows. NEB is a recognized leader in the discovery and production of enzymes for molecular biology applications with renowned products in sample preparation for NGS. NEBNext kits are designed and quality controlled to improve yields and library diversity, using a broad range of input amounts from a wide variety of sample types.
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SIGA | Hot Stocks08:23 EST Siga Technologies receives approval from EMA for tecovirimat - SIGA Technologies announced that the European Medicines Agency, EMA, approved SIGA's Marketing Authorisation Application, MAA, for oral tecovirimat, the same formulation that was approved by the U.S. Food and Drug Administration, FDA, in July 2018 under the brand name TPOXX. The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The MAA was filed under the centralized application process, which, upon approval, enables sales, including procurement for stockpiling, of oral tecovirimat in all European Union, EU, member states, as well as Norway, Iceland, and Liechtenstein.
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WTHVF | Hot Stocks08:22 EST Westhaven Gold completes initial MRE at Shovelnose Gold Property - Westhaven Gold announced the results from its Mineral Resource Estimate at its 100% owned 17,623-hectare Shovelnose Gold Property. The Shovelnose Gold Property is located within the prospective Spences Bridge Gold Belt, which borders the Coquihalla Highway 30 km south of the City of Merritt, British Columbia. The initial open-pit constrained MRE reported below is of the South Zone, and was completed by P&E Mining Consultants Inc., based on a total of 145 surface drill holes, 25,920 drill core analyses, 3,302 bulk density measurements, and preliminary metallurgical testwork. Shovelnose South Zone MRE Highlights: 791,000 ounces of gold and 3,894,000 ounces of silver Indicated. 263,000 ounces of gold and 1,023,000 ounces of silver Inferred. 75% of the MRE in the higher confidence Indicated classification: 10.60 million tonnes at 2.47 g/t for 841,000 gold equivalent ounces. Average AuEq grade of Indicated MRE is 7 times higher than the cut-off grade, demonstrating excellent potential for future economic extraction. Indicated mineralization is largely associated with the individual vein zones, whereas the Inferred is associated with the broader Veinlet Domain. This MRE is based on potential open-pit extraction - an MRE based on potential underground mining is in preparation and will be reported in the coming months. South Zone is just one of the many known mineralized zones on the Shovelnose Gold Property. Shovelnose is situated off a major highway, near grid power, rail, large producing mines, and within easy commuting distance from the City of Merritt.
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SEAT | Hot Stocks08:22 EST Vivid Seats reaches 100 millionth ticket milestone - Vivid Seats announced that it has reached its 100 millionth ticket sold milestone. "The milestone reflects Vivid Seats' growth at scale, connecting millions of buyers with thousands of sellers, and the continued and increasing consumer demand for live events," the company said. To celebrate the milestone, Vivid Seats has donated $100,000 to MusiCares. "Today's announcement is another example of the incredible momentum we are seeing as a brand and business," said Stan Chia, Chief Executive Officer of Vivid Seats. "We believe our marketplace delivers a seamless and trusted experience to help fans safely buy tickets at an exceptional value, so they can attend more of their favorite events. Whether they were cheering on their home-town sports team, rocking out to their favorite band, or attending acclaimed theater productions, we have been their trusted partner in delivering some of life's most exciting moments - a hundred million times over."
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SPCB | Hot Stocks08:21 EST SuperCom announces new government electronic monitoring contract in Wyoming - SuperCom announced that it has secured a new electronic monitoring contract in Wyoming. The contracting agency is an Adult and Juvenile Probation Agency and plans to use SuperCom's PureTrack GPS smartphone products to monitor their case load for location compliance. The contract is structured as a recurring per unit per day lease model, with billing at the end of each month.
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RICK | Hot Stocks08:20 EST RCI Hospitality reports Q1 club and restaurant sales $61.1M, SSS up 21.8% - Eric Langan, President and CEO of RCI Hospitality Holdings, said, "We had a strong first quarter as we benefited from legacy as well as new locations, namely our 11th Bombshells in Arlington, TX, which opened December 6, and the 12 clubs we acquired mid-October and early November. We didn't experience any noticeable impact from Omicron until late 1Q22 and hope it will cycle through our markets quickly. We look forward to our first Bombshells franchisee opening its San Antonio location in our March quarter. Full financial results for 1Q22 are expected to be reported by February 9th."
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ADMP | Hot Stocks08:20 EST Adamis Pharmaceuticals submits fast track application to FDA for tempol - Adamis Pharmaceuticals announced the submission of a Fast Track Application to the U.S. Food and Drug Administration for Tempol for the treatment and prevention of COVID-19. Tempol is currently being studied in a Phase 2/3 clinical trial in adult patients with confirmed COVID-19 infection. Tempol has been shown to have antiviral, anti-inflammatory, and antioxidant activity. Although recent oral antiviral drugs have been approved by the FDA, the Company believes that Tempol would provide an unmet medical need because of its unique mechanism of action and safety profile. Dr. Dennis Carlo, President and Chief Executive Officer of Adamis, commented, "Our ongoing clinical trial is continuing, as we see a surge in COVID-19 infections in the U.S. and worldwide. Concerns have been expressed about potential safety questions for EUA approved antivirals such as mutagenesis and drug-drug interactions. We are thus applying for Fast Track designation to the FDA to expedite the regulatory approval pathway for Tempol. Because Tempol has both anti-inflammatory and antiviral effects, we believe that Tempol fulfills an unmet medical need as an oral agent, focusing on multiple aspects of the pathogenesis of COVID-19 disease."
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CHRS | Hot Stocks08:19 EST Coherus Biosciences, Junshi expand immuno-oncology collaboration - Coherus BioSciences and Shanghai Junshi Biosciences announced that Coherus has initiated the process to exercise its option to license JS006, Junshi Biosciences' TIGIT-targeted antibody, in the United States and Canada, expanding the companies' 2021 immuno-oncology collaboration agreement. Coherus will pay Junshi Biosciences $35M upfront, up to $255M in development regulatory and sales milestones, and an 18% royalty on net product revenue, subject to terms and conditions agreed between the parties. Closing of the transaction is expected to follow receipt of any applicable regulatory clearances. Investigational new drug applications allowing clinical development of JS006 have been approved in Chinese Mainland and in the United States. A dose escalation, dose expansion clinical trial evaluating the safety, tolerability and pharmacokinetic properties of JS006 as monotherapy and in combination with PD-1 inhibitor toripalimab in patients with advanced solid tumors is ongoing.
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DXLG | Hot Stocks08:18 EST Destination XL reports $106.6M sales for 9-week holiday sales period - Destination XL Group announced the following results for the 9-week holiday sales period ended January 1, 2022. Total sales were $106.6 million compared to $78.4 million for the 9-week holiday sales period ended January 2, 2021 and $103.1 million for the 9-week holiday sales period ended January 4, 2020. As compared to fiscal 2019, comparable sales in our omni-channel retail business for the same 9-week holiday period increased 11.4%, primarily due to an increase in comparable sales from our direct business of 32.0% and an increase in comparable store sales of 3.2%. This comparable sales increase of 11.4% was partially offset by closed stores and a decrease in wholesale revenues, resulting in the 3.4% increase in total sales for the 9-week holiday period as compared to the same period of fiscal 2019.
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OMIC TWST | Hot Stocks08:17 EST Singular Genomics partners with Twist Bioscience - Singular Genomics Systems announced a partnership with Twist Bioscience to validate its NGS Target Enrichment Solutions, high-quality target enrichment panels either curated or custom, with the G4 sequencing platform. Twist NGS Target Enrichment Solutions provide an optimized workflow and easy customization of panel content. The combination of precise oligonucleotide synthesis and a scalable silicon-based manufacturing platform allows for the creation of high-performing probe panels.
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CGTX | Hot Stocks08:16 EST Cognition Therapeutics provides update on goals for 2022 - Cognition Therapeutics provided an outlined upcoming milestones anticipated in the year ahead. Key 2022 Goals and Initiatives: Progress the Phase 2 Alzheimer's Clinical Trials Consortium study with 540 early-stage AD patients, assessing cognition and biomarkers; Enroll the final cohort in the ongoing SHINE trial recruiting 120 patients with mild-to-moderate Alzheimer's disease; Expand the pipeline with Phase 2 dry AMD study and DLB studies; and Advance preclinical work in Parkinson's disease evaluating two -2 modulators for clinical development;.
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NCNO | Hot Stocks08:16 EST nCino completes acquisition of SimpleNexus - nCino announced that it has completed its acquisition of SimpleNexus, a leading cloud-based, mobile-first homeownership software company, for total consideration of approximately 12.76 million shares of nCino common stock plus cash consideration of approximately $270 million, on a cash-free, debt-free basis and excluding transaction expenses. The acquisition furthers nCino's commitment to transforming the financial services industry through innovation, reputation and speed. The SimpleNexus platform seamlessly unites the people, systems and stages of the home buying process into a single end-to-end experience, enabling loan officers, borrowers, real estate agents and settlement agents to easily engage in the homeownership process from any device. SimpleNexus' complementary products and mobile-first offerings will unlock additional opportunities and provide greater value for new and existing customers, including enhancing nCino's mobile and point-of-sale offerings across additional lines of business. For the fourth quarter ending January 31, 2022, nCino expects SimpleNexus will contribute between $3.6 and $3.8 million in total revenues from the closing date of January 7, 2022.
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IFRX | Hot Stocks08:15 EST InflaRx announces new pipeline program INF904 - InflaRx announced a new pipeline program, INF904, an oral small molecule inhibitor of C5aR. InflaRx recently has been granted a composition of matter patent for INF904 and associated compounds by the US Patent and Trademark Office and has completed IND-enabling studies that demonstrated no obvious toxicological findings even in the highest dose groups in required GLP toxicity analyses. In these preclinical studies, oral INF904 showed higher plasma exposure in animals, including non-human primates, and improved inhibitory activity in a hamster neutropenia model compared to the marketed C5aR inhibitor. Anti-inflammatory therapeutic effects in several preclinical disease models were also demonstrated by INF904. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments showed INF904 has substantially less inhibition of the cytochrome P450 3A4/5 enzymes, which play an important role in the metabolism of a variety of drugs, including glucocorticoids. InflaRx expects to initiate a Phase I program in the second half of 2022 and plans to study INF904 in complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.
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EQRX CVS | Hot Stocks08:15 EST EQRx enters MOU with CVS Health - EQRx (EQRX) announced it has entered into a memorandum of understanding, MOU, with CVS Health (CVS). "The companies plan to explore a long-term, strategic partnership to accelerate the commercial availability of lower-cost specialty therapeutics and create cost savings for CVS Health clients, patients and members through the adoption of EQRx medicines granted approval by the U.S. Food & Drug Administration," the company said. Initially, the companies plan to work together to support access to and adoption of EQRx's two lead oncology products, contingent upon FDA approval. EQRx and CVS Health will also explore opportunities for collaboration in support of their mutually aligned goal of bringing other innovative, lower-cost specialty medications to market. "Through this MOU, we are taking the first step towards realizing our shared objective to improve access to high-quality, innovative medicines at radically lower prices," said Melanie Nallicheri, chief executive officer of EQRx. "CVS Health is a trusted provider of pharmacy and medical benefits in communities across America. Together, we intend to bring significant cost savings to their clients, plan members, consumers and the broader U.S. healthcare ecosystem."
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FREE | Hot Stocks08:14 EST Whole Earth Brands appoints Duane Portwood as CFO - Whole Earth Brands announced the appointment of Duane Portwood as Chief Financial Officer, effective January 10, 2022. Mr. Portwood will report to Whole Earth Brand's Chief Executive Officer, Albert Manzone. Most recently, he was CFO for Tegra Global, a private sports apparel manufacturer.
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DBD | Hot Stocks08:14 EST Diebold partners with Compleo to provide EV charging stations in Europe - Diebold Nixdorf announced that it is partnering with Compleo, a full-service provider for charging technology in Europe, to provide a full range of Managed Services for charge point operators across Europe. Initially, the partnership will cover more than 1,000 DC fast charging stations for electric vehicles in public locations across Germany with the potential for expansion. Through this partnership, the companies will establish a comprehensive service concept. Compleo will provide the required hardware, software services and complete turnkey solutions, while Diebold Nixdorf will provide Managed Services, including responsive break/fix, preventive maintenance, helpdesk, monitoring, and data analysis. In this first step, Diebold Nixdorf's experienced service team will help guarantee a high standard of maintenance that specifically the group of international and cross-regional customers of Compleo like Volkswagen and other top-tier European vehicle manufacturers expect.
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OMIC | Hot Stocks08:14 EST Singular Genomics partners with Dovetail Genomics - Singular Genomics Systems announced a partnership with Dovetail Genomics to validate its proximity ligation kit portfolio, representing the leading methods to unlock access to 3-D genome architecture, with the G4 sequencing platform. The 3-D genome architecture at the nucleosome level is critical for understanding the regulation of gene expression. Dovetail's best-in-class products capture this 3-D genome architecture alongside primary sequence information using NGS. The long-range genomic information captured by Dovetail technology will enable more comprehensive detection of structural variation and chromosome-scale phasing on the Singular Genomics platform.
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OMIC | Hot Stocks08:13 EST Singular Genomics partners with Watchmaker Genomics - Singular Genomics Systems announced a partnership with Watchmaker Genomics to validate its Watchmaker DNA Library Prep Kits with Fragmentation for the G4 sequencing platform. Precision tools are needed across the entire genomics workflow - from sample input to information output - with library preparation being a critical determinant of data quality. Watchmaker solutions are designed to enable the development of highly sensitive, streamlined assays to unlock valuable insights from a variety of sample types.
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LSEA | Hot Stocks08:13 EST Landsea Homes closes on 200 new homesites in Palm Bay, Florida - Landsea Homes announced that it has closed on the land purchase for 200 additional homesites in Country Club Estates. This acquisition will become the fifth and final phase of the luxurious gated community in Palm Bay, Florida. This new phase at Country Club Estates is planned to include 154 detached single-family homes and 46 attached duplex single-family homes. Landsea Homes quickly sold out phases one through three at Country Club Estates, and is currently developing phase four, which consists of 68 homes. Site development for phase five is planned to commence in Q4 2022, followed by start of sales and home construction in early 2023.
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ASTL | Hot Stocks08:13 EST Algoma Steel expects all 37.5M shares to be issued pursuant to earnout rights - Algoma Steel Group announced that based on the current estimates of Algoma's Earnout Adjusted EBITDA for calendar year-end 2021, it is currently expected that all 37.5 million Algoma common shares will be issued pursuant to the Earnout Rights as prescribed in the Merger Agreement. "We were pleased with the Company's performance during the quarter, with expected financial results in line with our previous fiscal third quarter Adjusted EBITDA guidance, albeit on lower than planned shipments of approximately 550,000 tons, as compared to the previously issued guidance of 590,000 to 610,000 tons. Actual shipments were impacted by various issues including increased holiday shutdowns by customers, logistical supply chain constraints, and COVID-related challenges. As a result, our steel inventory has increased, and we expect to ship these deferred tons over the next two fiscal quarters. Algoma's high percentage of contract business offers stability during periods of volatility and this, combined with the strong demand and improving pricing we are seeing for our plate products, has positioned us well to continue delivering strong results to our shareholders," said Michael McQuade, Algoma's Chief Executive Officer.
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SESN MGNX | Hot Stocks08:13 EST Sesen Bio appoints Minori Rosales as chief development officer - Sesen Bio (SESN) announced the appointment of Minori Rosales as chief development officer as of January 24. Rosales will be responsible for medical and clinical strategic and operational leadership across the organization, including leading and executing an additional Phase 3 clinical trial for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. She brings over 15 years of clinical experience in pharmaceutical development, most recently as VP, clinical research at MacroGenics (MGNX), where she oversaw clinical development, including execution of clinical studies and management of global clinical safety and compliance, and led interactions with regulatory agencies.
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PSTX | Hot Stocks08:11 EST Poseida Therapeutics says Mark Gergen to transition to CEO role as of Feb. 1 - Poseida Therapeutics announced the appointment of Eric Ostertag as Executive Chairman and the transition of current President and Chief Business Officer, Mark Gergen, to the role of CEO effective as of February 1. Both Ostertag and Gergen will continue to serve as members of the company's Board of Directors.
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RPRX | Hot Stocks08:11 EST Royalty Pharma provides business update - Royalty Pharma provided an update on its business performance. "I am very pleased with the performance of Royalty Pharma in 2021," said Pablo Legorreta. "We strengthened our longstanding leadership position, delivered impressive financial results and deployed substantial capital on new royalty transactions which will help drive future growth. Given the extraordinary pace of medical advances and our unique role at the heart of funding life science innovation, I am confident that we will deliver attractive, compounding growth in the coming years." Royalty Pharma has previously disclosed that it expects to deploy approximately $7B in capital on new royalty transactions over the period 2020 to 2025. Given the rapid pace of life science innovation - and the accompanying demands for capital from the biopharma industry - the company is tracking well ahead of its plan. In total, through these transactions, 20 therapies have been added to Royalty Pharma's portfolio. These new medicines are expected to make a significant contribution to the company's financial performance in the coming years.
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OMIC | Hot Stocks08:11 EST Singular Genomics partners with Lexogen to enable RNA library prep - Singular Genomics Systems announced a partnership with Lexogen to demonstrate the G4 sequencing platform's compatibility with Lexogen's products for RNA research, specifically the QuantSeq, CORALL and LUTHOR library preparation kits. Transcriptome analysis has long been considered essential in answering key questions in biology and medicine. As pioneers in the field of RNA science, Lexogen has enabled RNA library preparation kits that are cost-efficient, streamlined and deliver complete transcript representation.
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EBIX | Hot Stocks08:10 EST EbixCash appoints Uma Shankar to board of directors - EbixCash Private Limited announced the appointment of Ms. Uma Shankar, as a new independent director to the EbixCash Board. Uma is a career banker, having retired as Executive Director at Reserve Bank of India after serving RBI for 37 years. Uma is presently an Independent Director on the Boards of Karnataka Bank as well as IDBI Capital Markets and Securities Ltd.
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NDLS | Hot Stocks08:10 EST Noodles & Company signs 55 restaurant franchise deal in CA with Warner Foods - Noodles & Company announced a partnership with Warner Foods, which operates over 150 Jack in the Box, Black Bear Diner, and Panera Bread restaurants, as its new exclusive franchise partner for the state of California. With a 12-year growth plan commitment, Warner Foods, which will operate as NorCal Noodles, under this agreement, will develop 40 new Noodles & Company locations throughout the state. Additionally, as part of the agreement, all 15 current company-owned Noodles & Company locations in California will be re-franchised to NorCal Noodles. The transaction is expected to close on Wednesday, January 12. Noodles & Company has entered a stage of rapid growth, expecting seven to nine new openings during the first quarter of 2022 and anticipating 8%-unit growth in 2022 and 10% annual growth thereafter.
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GILT | Hot Stocks08:10 EST Gilat Satellite announces extension to revenue managed services project - Gilat Satellite Networks announced that the Company received a 12-month extension on its recurring revenue managed services 4G cellular backhaul project with a leading Mobile Network Operator in Mexico.
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AUTL | Hot Stocks08:09 EST Autolus Therapeutics CFO Andrew Oakley to retire - Autolus Therapeutics announced that Andrew Oakley plans to retire from his position as chief financial officer with effect from 31 March 2022 and will concentrate on non-executive director roles. He currently serves on the Boards of Union Therapeutics A/S and Novaremed AG. Andrew will remain a senior advisor to Autolus until March 2023. Dr. Lucinda Crabtree, senior vice president of finance at Autolus, will be appointed chief financial officer following his retirement.
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MDT | Hot Stocks08:08 EST Medtronic says Evolut PRO TAVR system approved in China - Medtronic announced the National Medical Products Administration has approved the CoreValve Evolut PRO TAVR system for the treatment of severe aortic stenosis for symptomatic patients in China who are at high or extreme risk for open heart surgery. As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak and excellent hemodynamics. Full commercial launch is anticipated in early calendar year 2022.
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RNLX | Hot Stocks08:08 EST Renalytix, Singing River Health announce partnership to deploy KidneyIntelX - Singing River Health System and Renalytix announced a partnership to deploy KidneyIntelX informed care management to improve kidney health in individuals with type 2 diabetes and early-stage chronic kidney disease. The Renalytix KidneyIntelX platform enables Singing River's primary and specialty care providers to easily identify and understand a person's kidney health risks, implement medication and nutrition management, and provide educational intervention on a timely basis. "The partnership between Singing River and Renalytix will focus on improving health outcomes and reducing healthcare costs in this high-risk population by driving early detection and providing informed care in seeking to delay disease progression and prevent unnecessary dialysis starts," the company said. "From the beginning, Renalytix has been committed to taking immediate action to mitigate racial and economic disparities in kidney disease care," said Tom McLain, President of Renalytix. "In addition to our new partnership with Singing River, we have secured provider agreements with 27 state Medicaid programs. We believe that precision medicine approaches, including KidneyIntelX, will ensure that the right treatment gets to the right patients, regardless of population type, economic status or health insurance coverage."
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EMOTF | Hot Stocks08:08 EST Emerita Resources reports publication of resolution by Huelva Province - Emerita Resources announces that the Andalucian Environment Department in Huelva Province has issued its resolution and published it in the official gazette approving the Company's diamond drill plan for the west side of the Iberia Belt West project on January 7, 2022 such that the entire Project is now permitted for drilling. This portion of the IBW Project hosts the large Romanera deposit and the El Cura deposit and as such this is an important step for the ongoing evaluation of the IBW Project. The publication in the gazette marks the commencement of a 30 business day period during which the reclamation plan for the drill sites are published on the government web site and available for comment. The application process in Spain requires a comprehensive exploration plan as well as a reclamation plan for the drill pads and the reclamation plan is published on the government web site for public viewing for a period of 30 days prior to issuing the permits. Permitting the west side of the project required a more involved process than the Infanta area where the Company has been drilling. The Company completed all studies required by the process including archaeological, flora and fauna studies and has written support from the two municipalities, Pueblo de Guzman and Paymogo, that encompass the project included in the filing documents. Once issued, the permits are valid for the duration of the license. The Company already has agreements arranged with local landowners for access to the drill sites in order that work can commence immediately upon receiving the permits. Emerita presently has a contract for five drills on the IBW Project and will add three more drills bringing the total to eight, to coincide with the issuing of this permit in order to complete the drilling required for a NI 43-101 compliant mineral resource estimate as quickly as practical.
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ITOS | Hot Stocks08:07 EST iTeos Therapeutics announces clinical development plans - EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to optimize its affinity, potency and activity, engage the Fc gamma receptor, and to enhance the anti-tumor response through a multifaceted mechanism. iTeos plans to initiate various combinations of potential next generation immuno-oncology agents: In partnership with GSK, the company is assessing the doublet of GSK's anti-PD-1 with EOS-448 in 1L PDL1high non-small cell lung cancer, head and neck squamous cell carcinoma and an additional indication in registration-directed trials. The companies are also initiating trials with novel triplets, including dostarlimab with EOS-448 and inupadenant as well as EOS-448 with dostarlimab and GSK's anti-CD96 antibody, GSK'608. iTeos is examining the doublet of pembrolizumab with EOS-448 in patients with solid tumors in an ongoing Phase 1 trial and inupadenant with EOS-448 in PD-1 resistant melanoma in an ongoing Phase 2a trial. The company is advancing an ongoing open-label, multicenter, dose-escalation/expansion Phase 1/2 trial evaluating the safety, tolerability and preliminary activity of EOS-448, to the combination phase with Bristol Myers Squibb's immunomodulatory imide drug, iberdomide, with or without dexamethasone, in adults with relapsed or refractory multiple myeloma, based on strong preclinical data generated with Fred Hutchinson Cancer Research Center. Inupadenant Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment. iTeos plans to initiate a randomized Phase 2 trial in a solid tumor indication to evaluate the combination of inupadenant with chemotherapy compared to standard of care. The company is also evaluating inupadenant in combination with pembrolizumab in PD-1 resistant melanoma in an ongoing Phase 2a trial. iTeos is evaluating patient and indication selection biomarkers in the ongoing Phase 1b/2a trial of inupadenant as a monotherapy.
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ITOS | Hot Stocks08:06 EST iTeos Therapeutics appoints Yvonne McGrath as CSO - In the role of chief scientific officer, Dr. McGrath will be responsible for the continued advancement of iTeos's pipeline of immunotherapy candidates in advanced cancers. She has served as vice president of R&D since June 2020, bringing more than 20 years of experience in immuno-oncology, clinical development and R&D.
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APM | Hot Stocks08:06 EST Aptorum Group completes Phase I clinical trials for ALS-4 and SACT-1 - Aptorum Group announces completion of the Phase I clinical trial for ALS-4, a first in-class anti-virulence based small molecule drug targeting infections caused by Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus and the Phase I clinical trial for assessing relative bioavailability and food effect of SACT-1, a repurposed small molecule drug targeting Neuroblastoma and potentially other cancer types. ALS-4's first-in-human Phase I trial is a randomized, double-blinded, placebo-controlled, single and multiple ascending dose study designed to evaluate safety, tolerability, and pharmacokinetics of orally administered ALS-4 in healthy male and female adult volunteers. Dosing and clinical evaluations of the Single Ascending Dose studies and Multiple Ascending Dose studies have now been completed for a total of 72 healthy subjects and Aptorum is pleased to announce that no subjects were dropped from the studies. There were no Serious Adverse Events observed and no relevant clinical changes in respect of vital signs; ECG, clinical laboratory test results and physical examinations were observed compared to the relevant baseline in both SAD and MAD . The safety data of the last SAD cohort and MAD cohort are pending. With the encouraging safety data in our Phase 1 trial, we are on track to submit an IND application to the US FDA this year seeking to initiate a Phase 2 clinical study to assess the efficacy of ALS-4 in patients. SACT-1's first in-human clinical trial is a Phase 1, Open-label Randomized, Single Cross Over Bioavailability and Food Effect Study of SACT-1 in healthy adult volunteers. Aptorum is pleased to announce the successful completion of the trial, during which no SAE were observed. With the encouraging data in our trial so far, we are on track to submit an IND application to the US FDA this year seeking to initiate our planned Phase 1b/2a trial for SACT-1. Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: "Further to our previous announcements, we are pleased to announce the completion of the above clinical trials for ALS-4 and SACT-1. This represents another key milestone for the company and one of the targeted strategic goals we had for 2021. This milestone supports the focus of Aptorum Group to embark on the exciting Phase II clinical trials for ALS-4 and planned Phase Ib/2a clinical trials for SACT-1, subject to IND clearance. The World Health Organization deems MRSA a high priority due to its significant mortality risks1. Neuroblastoma is a highly unmet solid tumor arising in the nervous system outside of the brain predominantly in pediatric patients. We believe that both ALS-4 and SACT-1 have the potential to effectively target these diseases, respectively and address the unmet needs in this area."
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BDTX | Hot Stocks08:04 EST Black Diamond Therapeutics announces strategic priorities, expected milestones - Black Diamond Therapeutics announced a strategic pipeline update and outlined its expected upcoming milestones. Pipeline Updates and Expected Milestones: BDTX-1535: Black Diamond announced ahead of schedule the submission of its Investigational New Drug application to the US Food and Drug Administration for BDTX-1535 and expects to initiate the Phase 1 study of BDTX-1535 in the first quarter of 2022, subject to allowance of the IND by the FDA; The Company expects to provide a clinical data update on BDTX-1535 in the second half of 2023. BDTX-189: BDTX-189 is designed as a MasterKey inhibitor targeting families of oncogenic mutations in EGFR and HER2; Clinical data obtained from the MasterKey-01 study to date have demonstrated a favorable safety profile for BDTX-189; Due to the rapid evolution of the treatment landscape, the Company has decided to gate the initiation of the Phase 2 portion of the MasterKey-01 study and determine next steps in development based on further clinical data obtained from the safety expansion cohort at the recommended Phase 2 dose; The Company expects to provide further guidance on the BDTX-189 program in 2022. BRAF Program: Black Diamond is developing a CNS-penetrant BRAF inhibitor against a family of Class I, II, III canonical and non-canonical mutations. The Company's lead BRAF compound is designed to be highly selective, potent and to avoid paradoxical activation; Black Diamond anticipates the initiation of IND-enabling studies for the BRAF program in 2022. MAP Discovery Engine: The Company continues to focus on building its Mutation-Allostery-Pharmacology Discovery Engine to exploit mutant onco-protein conformations for the delivery of selective MasterKey therapies, with a focus on developing a MasterKey inhibitor that spares wild type fibroblast growth factor receptor 1 while inhibiting FGFR2 and FGFR3 mutant families, as well as other preclinical stage programs.
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VITFF | Hot Stocks08:04 EST Victoria Gold amends credit facilities - Victoria Gold has amended its existing credit agreement on favourable terms, lowering the payable interest rate by 50 basis points on both the revolving and term loan tranches. Pursuant to the amendment, amounts drawn on the Facilities are subject to interest at LIBOR plus 2.50% to 3.50% per annum, with the undrawn portion subject to a standby fee of 0.56% to 0.79% per annum. Pricing is dependent on the Company's leverage ratio, with the operative margin and standby fee amounting to 2.75% and 0.62% per annum, respectively, at present. The maturity date of the revolving facility has also been extended to December 2024 from December 2023. The term facility continues to be paid quarterly and matures in December 2023 The term tranche of US$100 million was fully drawn upon at its inception and used to repay the previously outstanding project finance facility, which included senior and subordinated debt that was used for the construction of the Eagle Gold Mine. The term tranche principal is currently US$67 million. The revolving tranche of up to US$100 million may be drawn upon and repaid any time through maturity and is available for general corporate and operating purposes subject to customary terms and conditions. The revolving tranche principal is currently US$68 million.
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BFARF | Hot Stocks08:03 EST Bitfarms buys 1,000 bitcoin - Bitfarms provides a Bitcoin purchase and treasury update. Emiliano Grodzki, Bitfarms Founder and Chief Executive Officer, said, "Our guiding company strategy at Bitfarms is to accumulate the most Bitcoin for the lowest cost and in the fastest amount of time for the benefit of our shareholders. To that end, we continually optimize our capital allocation. With the dip in BTC while mining hardware prices remain high, we seized the opportunity to move cash into BTC. We continue to be committed to executing our operational growth strategy and delivering our goal of 8 exahash/second by the end of 2022."bDuring the first week of January 2022, Bitfarms purchased 1,000 BTC for US$43.2 million. This increased the BTC holdings 30% to over 4,300 as of January 10, 2022. For reference, 1,000 BTC is roughly equivalent to the amount Bitfarms added to the treasury in the third quarter of 2021 and again in the fourth quarter of 2021.
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BDTX | Hot Stocks08:03 EST Black Diamond Therapeutics expects cash to fund operations into 2024 - Black Diamond ended 2021 with approximately $210M in cash, cash equivalents and investments.
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TCRX | Hot Stocks08:03 EST TScan Therapeutics outlines 2022 priorities - TScan Therapeutics announced that the Company plans to begin its first clinical trials this year. As forecasted, in December 2021 TScan filed INDs for TSC-100 and TSC-101, its TCR-T programs to prevent relapse in leukemia patients following hematopoietic cell transplants. In addition, TScan is outlining here its priorities for 2022 across its pipeline of solid and liquid tumors as well as infectious disease. 2021 Accomplishments and 2022 Pipeline Objectives: Liquid Tumor Programs: TScan's two lead liquid tumor TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, and treat patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation. During the fourth quarter of 2021, the Company completed investigational new drug-enabling studies and submitted IND applications to the U.S. Food and Drug Administration for TSC-100 and TSC-101. Following the IND submissions and pending acceptance by the FDA, the Company expects to initiate Phase 1 clinical trials for TSC-100 and TSC-101 in the first half of 2022, with preliminary data expected in the second half of 2022. In December 2021, the Company shared clinical trial designs for TSC-100 and TSC-101 in a poster at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition. The Company provided further detail on the clinical rationale and trial design for the program in a virtual event with TScan management and Yi-Bin Chen, M.D., M.S., Director, Hematopoietic Cell Transplant and Cell Therapy Program, Allan B. Rogers, Jr. and Cara J. Rogers Endowed Chair, Massachusetts General Hospital, Associate Professor of Medicine, Harvard Medical School. Solid Tumor Programs: TScan's TSC-2xx series of TCR-T therapy candidates include a combination of known targets, such as HPV16 for TSC-200, PRAME for TSC-203, and MAGE-A1 for TSC-204, as well as targets that are novel antigens for TCR-T therapy, such as those for TSC-201 and TSC-202. TScan plans to present initial preclinical data on the TSC-2xx series at a medical meeting in the first half of 2022. TScan plans to progress IND-enabling studies for the TSC-2xx series and submit multiple IND applications during the second half of 2022. Among these will be TSC-200 for HPV, which is a validated cancer target found in every cell of HPV-positive tumors, including many cases of head & neck and cervical cancer. Using its TargetScan platform, TScan discovered a novel HLA-C*07:02-restricted epitope encoded by the well-known cancer/testis gene MAGE-A1. This cancer-specific gene is frequently overexpressed in a wide variety of solid tumors, including as many as 45% of head & neck cancers, 50% of melanomas, 50% of cervical cancers and 50% of non-small cell lung cancers. In late 2021 TScan announced a new program, TSC-204, for MAGE-A1 that will include multiple TCRs for different HLA-restricted epitopes on this target. TScan believes that it is the only company with a disclosed TCR program in MAGE-A1 for HLA types other than A*02:01. The Company anticipates filing an IND for TSC-204 in the second half of 2022. In 2023, the Company plans to release initial clinical data for the TSC-2xx series TCRs, as well as file further INDs for additional programs in this series. Infectious Disease Program:Research is continuing into potential T cell focused COVID-19 vaccine constructs utilizing TScan's novel T cell target discoveries. The Company is currently conducting IND-enabling activities for this program and will provide an update in 2022. Proprietary Platform: In 2021, using its proprietary TargetScan discovery platform, TScan identified over 110 novel solid tumor targets in tumor samples from patients who have responded to immunotherapy. The Company has already developed an extensive library of known and novel solid tumor targets across different HLA types named ImmunoBank. In 2022, the Company will provide a further update on the progress of its ImmunoBank, which will include an even greater array of validated novel cancer targets across multiple HLA types. This will allow the Company to develop a pipeline of product candidates for highly prevalent solid tumor indications that allow for multiplexing across targets and HLAs to provide durable responses to a majority of patients. TScan completed the construction and validation of a 7,000 square-foot state-of-the-art GMP manufacturing facility to manufacture all necessary Phase I/II supply for its TCR-T therapies. This facility supported the Company's first two IND filings and provides sufficient production capacity to supply product for all planned Phase I and II clinical studies for the liquid and solid tumor programs
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CNVY | Hot Stocks08:02 EST Convey Health Solutions to acquire HealthSmart International for $77.5M in cash - Convey Health Solutions announced that it entered into a definitive agreement to acquire HealthSmart International for $77.5M in cash. The transaction is subject to customary closing conditions, with up to $15M of additional cash payable if HealthSmart achieves certain 2022 revenue targets. The acquisition of HealthSmart will further expand Convey's mission to provide industry leading solutions and services that improve health plan operations and elevate the member experience. The parties expect to close the transaction during the first quarter.
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AUTL | Hot Stocks08:01 EST Autolus Therapeutics announces 2022 priorities - Autolus Therapeutics announced its 2022 corporate priorities and provided guidance. "We are on track to complete patient recruitment in the FELIX study of obe-cel in adult ALL patients with the first data expected around the middle of the year," said Dr. Christian Itin, chief executive officer of Autolus. "This study is the key driver for the Company over the coming months and we are working diligently to shape the product profile and the commercial strategy of obe-cel, whilst laying the foundation for progressing our other differentiated CAR T cell products. We are very excited about the year ahead, which could be a transformational year for Autolus." Key Anticipated Clinical Milestones: Updates on the FELIX trial, where Autolus is evaluating obe-cel in r/r adult ALL patients. The trial is currently enrolling patients into the Phase 2 portion. Autolus expects data from the Phase 2 trial to be available in 2022; Updates from the ALLCAR19 extension trial in patients with r/r B-NHL and CLL and longer-term follow-up of the fully enrolled r/r adult ALL cohort expected in H1 2022; Updates on the obe-cel Phase 1 trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022; Clinical data from the AUTO1/22 CARPALL extension trial in pediatric ALL expected in H1 2022 with longer follow up in H2 2022; Updates on the AUTO4 Phase 1 trial in TRBC1+ Peripheral TCL expected in H1 2022; Phase 1 trials are expected to be initiated in H1 2022 with AUTO6NG in Neuroblastoma and AUTO8 in Multiple Myeloma
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LIAN BMY | Hot Stocks08:00 EST LianBio announces first patient dosed in Phase 3 trial of mavacamten - LianBio (LIAN) announced the first patient has been dosed in the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy, oHCM. "With more than one million estimated patients, China is home to the world's largest hypertrophic cardiomyopathy population," said Yizhe Wang, Ph.D., chief executive officer of LianBio. "In global clinical trials, mavacamten demonstrated statistically significant and clinically meaningful benefit in oHCM patients. LianBio is committed to accelerating access to this potentially transformative, first-in-class cardiac myosin inhibitor, and we have designed the pivotal EXPLORER-CN trial to support New Drug Application filing in China." Mavacamten is a potential allosteric modulator of cardiac myosin in development for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause of disease. LianBio in-licensed rights from MyoKardia, now a wholly owned subsidiary of Bristol-Myers Squibb (BMY), for the development and commercialization of mavacamten in Mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore.
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ABBV | Hot Stocks08:00 EST Frontier Medicines advances first program under AbbVie partnership - Frontier Medicines Corporation announced the first target for the development of a small molecule inhibitor is advancing into the lead generation phase under the company's global partnership with AbbVie. The global partnership was established in December 2020 to discover, develop, and commercialize a pipeline of innovative small molecule therapeutics against certain high-interest, difficult-to-drug protein targets.
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CLBT | Hot Stocks07:59 EST Cellebrite wins open-source intelligent solutions customer contract - Cellebrite announced that it has won a significant Open-Source Intelligence customer contract following the Company's acquisition of Digital Clues in November 2021. The new customer contract is a multi-year contract with initial value of US$1.5 million for the first year and is the most noteworthy SaaS deal for Cellebrite to date.
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EWCZ | Hot Stocks07:58 EST European Wax Center provides update ahead of presentation at ICR conference - European Wax Center provided an update ahead of its virtual presentation at the 24th Annual ICR Conference. David Berg, Chief Executive Officer of European Wax Center, Inc., stated: "I am extremely proud of our development team for delivering 57 net new centers in fiscal 2021, nearly all of which were opened by existing franchisees. We believe this reflects our strong relationship with the network and their steadfast commitment to our future growth. We executed significant multi-unit commitments and ended the year with our deepest pipeline ever of more than 330 locations. Within our centers, we continued to delight our guests with excellent service in a trusting environment, leading to considerable growth in new guests versus 2019. We continue to monitor the impact of COVID and its variants, and we expect fiscal 2022 financial performance at least in line with our long-term growth targets. Most importantly, we remain focused on the significant opportunity ahead to leverage our leadership position in out-of-home waxing and our asset-light business model to fuel value creation for all European Wax Center stakeholders."
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TNMCF | Hot Stocks07:57 EST Titan Mining extends credit facility maturity dates - Titan Mining Corporation announces that it has extended the maturity dates of its credit facilities with each of the Bank of Nova Scotia and a company controlled by Titan's Executive Chairman. Additionally, the Company made an initial repayment against the BNS facility of US$2,000,000 in the fourth quarter of 2021. The maturity date of the BNS senior secured revolving credit facility with a limit of US$10,000,000 has been extended from April 3, 2022 to April 3, 2023 and the maturity date of the Company's second ranking secured credit facility of US$20,710,000 with the Lender has been extended from April 5, 2022 to April 5, 2023. In consideration of the extension of the Company's credit facility with the Lender, the Company paid an extension fee to the Lender in the amount of US$75,000.
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TLSA | Hot Stocks07:57 EST Tiziana Life Sciences enrolls second patient in ongoing treatment of SPMS - Tiziana Life Sciences announces that the U.S. Food and Drug Administration allowed enrollment of a second patient in the ongoing clinical treatment of secondary progressive multiple sclerosis, SPMS, with intranasally administered foralumab, a fully human anti-CD3 monoclonal antibody, at the Brigham and Women's Hospital, Harvard University, Boston, MA. The first patient treated under this program completed 3 out of 6 months of dosing. Interim data suggest that the treatment was well-tolerated with a favorable clinical response. As part of the regulatory process, three-month safety data were submitted to the FDA, seeking permission to treat an additional patient under an Individual Patient Expanded Access Investigational New Drug Application, which has been allowed. Treatment of the second patient is expected to begin during January 2022 with interim clinical data after 3 out of 6 months of treatment expected in April 2022. The treatment plan will remain unchanged as per the original IND. The ongoing treatment of the first patient continues, and six months of dosing is expected to be completed by the end of March 2022. To date, this patient has not shown signs of treatment intolerance or toxicities and appears to be responding well to treatment. The brain imaging data, as analyzed by PET, show reduction in microglial cell activation.
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SKYE | Hot Stocks07:55 EST Skye Bioscience issues shareholder letter providing update, business outlook - Skye Bioscience issued the following letter from Chief Executive Officer and Chair, Punit Dhillon. "Dear Shareholders, Colleagues and Collaborators... Today, I am pleased to provide you with updates on our progress and insight into 2022... SBI-100: Opportunity to Transform the Treatment of Glaucoma... In 2021, we completed several important preclinical studies to demonstrate the safety and efficacy of SBI-100... in vivo efficacy studies included a combination study that again demonstrated SBI-100's ability to decrease intraocular pressure to a greater degree and over a longer duration than the standard of care for the treatment of glaucoma as a standalone agent... Before the end of 2021, we also completed a neuroprotection study to assess the potential of SBI-100 to protect retinal ganglion cells in an optic nerve crush model. We plan to share additional details from both studies upon a thorough review of the findings in the near term... We are fast approaching the initiation of our first-in-human Phase I study in the first half of 2022, with topline data expected in the third quarter of 2022 and the full data readout in the fourth quarter... What is more significant, of course, is potentially demonstrating the IOP-reducing effects of SBI-100 in patients with glaucoma. We have therefore laid out a plan to initiate a Phase II study before the end of 2022... As of September 30, 2021, our cash position was $11.1M, an increase of $6.9M from $4.2M on September 30, 2020. Our working capital was $9.9M and stockholders' equity was $8.3M, positioning us with the strongest balance sheet in the Company's history and enabling us to advance our development initiatives... At Skye, our innovation and development strategy and value creation plan are linked to the following milestones for 2022: 1. Completion of a Phase I study to establish safety and tolerability of SBI-100 in humans. 2. Initiation of a robust placebo and active-controlled Phase II study for SBI-100 in glaucoma. 3. Development of a drug development platform to uncover novel molecules and mechanisms of action capable of modulating the endocannabinoid system to improve outcomes for a broad set of ophthalmic disease"
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PASG | Hot Stocks07:54 EST Passage Bio announces 2022 research, clinical development goals - Passage Bio will share the company's 2022 outlook in a presentation today at the 40th Annual J.P. Morgan Healthcare Conference. Specifically, the company will provide an update on the status of its clinical programs, its CNS research pipeline, and additional key initiatives, including investment in a pilot manufacturing suite. Key Anticipated Company Highlights in 2022 Clinical Programs: Imagine-1 - Global Phase 1/2 Trial for PBGM01 for GM1 Gangliosidosis: Plan to deliver at 18th Annual WORLDSymposium a late-breaker presentation of additional safety and biomarker data as well as preliminary clinical results for Cohort 1 on February 11; and a presentation on the clinical trial design on February 9. Expect to dose first patients in Cohort 2 in early 2022. upliFT-D - Global Phase 1/2 Trial for PBFT02 for Frontotemporal Dementia with Granulin Mutations: Expect to dose first patient in early 2022. GALax-C - Global Phase 1/2 Trial for PBKR03 for Krabbe Disease: Expect to dose first patient in early 2022; Plan to present the clinical trial design at the 18th Annual WORLDSymposium on February 9. Research-Stage Pipeline: Plan to submit an Investigational New Drug application for the Phase 1/2 clinical program for metachromatic leukodystrophy in mid-year; Advance pipeline programs for amyotrophic lateral sclerosis, Charcot-Marie-Tooth Type 2A, Parkinson's disease, Canavan disease and Huntington's disease; Progress target identification research programs for Alzheimer's and temporal lobe epilepsy; Evaluate new product candidate programs with the University of Pennsylvania's Gene Therapy Program to continue to expand pipeline in 2022; Passage Bio has a total of 17 program license options with GTP, and has thus far exercised nine of these options Manufacturing: Operationalize new pilot manufacturing suite by year-end 2022 at the Princeton West Innovation Campus in Hopewell, N.J., for scale-up capability to support R&D pipeline as well as future development plans
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NRIX | Hot Stocks07:52 EST Nurix Therapeutics outlines 2022 catalysts - Nurix Therapeutics outlined key objectives and anticipated milestones for 2022 and provided an overview of recent progress. Pipeline: Planned data presentations from all four clinical programs in 2022 as described below: NX-2127: Nurix's lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of Bruton's tyrosine kinase with immunomodulatory drug activity. Nurix plans to initiate the Phase 1b expansion phase of its ongoing Phase 1a/1b clinical trial of NX-2127 in adults with relapsed or refractory B cell malignancies in mid-2022 and to present additional data from the Phase 1a trial in the second half of 2022. NX-5948: Nurix's second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without IMiD activity for certain B-cell malignancies and autoimmune diseases. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B cell malignancies and expects to begin dosing at multiple clinical centers in the United Kingdom in the first half of 2022 and to have initial safety and pharmacokinetic and pharmacodynamic data from the Phase 1a portion of the study in the second half of 2022. NX-1607: Nurix's lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of Casitas B-lineage lymphoma proto-oncogene for immuno-oncology indications including a range of solid tumor types. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in mid-2022. DeTIL-0255: Nurix's lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Nurix anticipates dosing the first patient in the first half of 2022 and providing a clinical update from the run-in portion of the study in the second half of 2022. Nurix plans to host an investor event in the first half of 2022 to provide a comprehensive update on its lead programs and DELigase discovery platform.
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EDIT BMY | Hot Stocks07:51 EST Editas Medicine reports on recent progress, outlook on programs - Editas Medicine (EDIT) announced the company's recent progress and upcomning milestones. In Vivo Gene Edited Medicines Outlook: Editas Medicine completed dosing of all adult cohorts in its BRILLIANCE study of EDIT-101; the Company remains on track to complete dosing of the pediatric mid-dose cohort in the first half of 2022; Additionally, the Company is expanding enrollment in one or more of the previously completed adult cohorts to support anticipated registrational trial design and endpoints; Editas also expects to provide a clinical update on the BRILLIANCE trial in the second half of 2022; The Company also anticipates establishing registrational trial criteria for EDIT-101 by year-end 2022; The Company is advancing additional in vivo ocular editing programs, leveraging its learnings from EDIT-101, and has declared a new development candidate, EDIT-103, for treatment of rhodopsin-associated autosomal dominant retinitis pigmentosa which is progressing towards IND-enabling studies; An optimized version of EDIT-102 for treatment of Usher syndrome 2A-associated retinitis pigmentosa is in lead optimization; The Company expects to declare an additional new development candidate for an in vivo ocular indication in 2022. Ex Vivo Gene Edited Medicines Outlook - The Company is developing EDIT-301 for the treatment of sickle cell disease and transfusion-dependent beta thalassemia. The Phase 1/2 RUBY trial for the treatment of sickle cell disease is currently enrolling study participants and is on track to begin dosing in the first half of 2022 with initial clinical results expected by the end of 2022. The Company recently received clearance from the U.S. Food and Drug Administration of its investigational new drug application for EDIT-301 for the treatment of TDT, and expects to initiate dosing in a Phase 1/2 clinical study in TDT during 2022. Cellular Therapy Outlook: Editas Medicine has announced the development candidate EDIT-202. Editas Medicine expects to further optimize and advance this therapy in preclinical development during 2022. The ongoing collaboration between Editas Medicine and Bristol Myers Squibb (BMY) continues to advance alpha-beta T cell medicines for the treatment of solid and liquid tumors. Editas Medicine continues to evaluate the application of its iPSC platform to additional cell types beyond iNK and alpha-beta T cells. These include gamma-delta T cells for oncology indications and multiple cell types for regenerative medicine applications of iPSCs.
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HQI | Hot Stocks07:51 EST HireQuest acquires dmDickason's staffing division - HireQuest announced that it has entered into a definitive agreement to acquire the staffing division of dmDickason Personnel Services, a family-owned company based in El Paso, Texas. The staffing division has three offices, two in El Paso, Texas, and one in Las Cruces, New Mexico, which generated approximately $18M in revenue in 2021. "This acquisition expands our Snelling footprint in west Texas and New Mexico," commented Rick Hermanns, HireQuest's President and Chief Executive Officer. "dmDickason started in 1965 as one of the earliest Snelling franchises and for over 40 years Don and Martha Dickason have been providing exceptional service to businesses and job candidates in the greater El Paso area. It's great to be able to acquire a business with such a long history and we're excited to bring the Snelling name back to region." The three offices will be converted into Snelling franchise locations at the close of the transaction. HireQuest will fund this acquisition with existing cash on hand and a modest draw on its line of credit. Completion of this transaction is subject to a number of closing conditions. Subject to such conditions, the transaction is expected to close in the first quarter of 2022. During the interim, the staffing division of dmDickason will remain open for business without interruption.
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ORTX | Hot Stocks07:50 EST Orchard Therapeutics expects cash to fund requirements into 1H23 - The company ended 2021 with approximately $220 million of cash and investments. The company expects that its cash, cash equivalents and investments as of December 31, 2021 will support its currently anticipated operating and capital expenditure requirements into the first half of 2023. This cash runway excludes an additional $67 million that could become available under the company's credit facility and any non-dilutive capital received from potential future partnerships or priority review vouchers granted by the FDA following future U.S. approvals.
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ORTX | Hot Stocks07:50 EST Orchard Therapeutics announces progress for HSC gene therapy programs - Orchard Therapeutics outlined commercial and regulatory updates and key 2022 milestones in advance of its attendance at the virtual 40th Annual J.P. Morgan Healthcare Conference. These activities and priorities support the company's vision to end the devastation caused by genetic and other severe diseases through the curative potential of HSC gene therapy. Libmeldy Commercial Updates in Europe: As part of Orchard's objective to build a successful and sustainable commercial business in HSC gene therapy, the company is focused on three foundational pillars of the Libmeldy launch: market access, patient identification and treatment delivery. Market access: Health technology assessments are progressing well across Europe. The company is pleased that the HTA bodies have recognized both the severity of MLD and the magnitude of potential therapeutic benefit of Libmeldy to treat this condition. For example, in Germany, Libmeldy is one of only five medicines to ever achieve the highest possible therapeutic benefit rating of "major benefit" for pre-symptomatic MLD patients. Orchard anticipates reaching reimbursement agreements with at least two countries in the first half of 2022. Patient identification: Patient identification efforts are progressing well, and two patients, one in France and one in Germany, are in the process of being treated commercially with Libmeldy under reimbursed early access. Activities are also underway to drive a timely MLD diagnosis, including five newborn screening studies or pilots that have launched or are planned in Germany, Italy, the UK, Spain and France. Treatment delivery: Four centers with specialized expertise in transplant and disease area knowledge in Germany, Italy, France and the Netherlands are treatment-ready and activation of a fifth center in the UK is in progress. Regulatory Progress and Upcoming Milestones for OTL-200 and OTL-103 OTL-200 for MLD: Orchard has completed the majority of the activities necessary in advance of a pre-Biologics License Application meeting with U.S. Food and Drug Administration for OTL-200. In December 2021, a Type B CMC meeting took place with the FDA, the feedback from which confirms a planned BLA submission timeline of late 2022 to early 2023. OTL-103 for WAS Following productive regulatory interactions with the European Medicines Agency and recent rapporteur and co-rapporteur meetings, Orchard is preparing for a Marketing Authorization Application submission for OTL-103 in Europe in mid-2022. In the U.S., Orchard is planning to interact with FDA in early 2022 to discuss elements of a potential BLA filing package, including development work on a functional potency assay and the clinical dataset. Orchard is utilizing the benefits provided under FDA's regenerative medicine advanced therapy designation for both OTL-103 and OTL-200's regulatory interactions in the U.S. Additional 2022 Corporate Priorities To lead the development of gene therapies for neurodegenerative disorders and investigate the potential of HSC gene therapy in future indications where there is a compelling scientific and clinical rationale, Orchard has outlined the remaining key milestones expected for 2022: OTL-203 for MPS-IH: Obtain the necessary regulatory clearance in mid-2022 to enable the initiation of the OTL-203 global registrational study in MPS-IH by year end. OTL-201 for MPS-IIIA: Present clinical data, including early clinical outcomes of cognitive function, from the OTL-201 proof-of-concept trial in the first half of 2022. Research programs: Advance the company's preclinical portfolio, which includes programs focused on neurodegenerative disorders, immunological diseases and HSC-generated antigen-specific Tregs.
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USEG | Hot Stocks07:48 EST U.S. Energy announces closing of acquisitions - U.S. Energy announced the successful closing, on January 5, 2022, of the previously announced transactions to purchase certain oil and gas assets from Lubbock Energy Partners LLC, Synergy Offshore LLC, and certain entities controlled by Sage Road Capital. The Acquired Assets represent an operated portfolio of low decline, oil weighted assets across the Rockies, West Texas, Eagle Ford, and Mid-Continent. The acquisitions create a diversified, low leverage, free cash flow generating U.S. independent oil and natural gas company focused on continued consolidation. U.S. Energy issued an aggregate of 19,905,736 shares of common stock paid $1.25 million of cash, and assumed $3.5 million of indebtedness from the Sellers as part of the Transactions, equating to total consideration of $72.4 million. The issuance of the shares of common stock in connection with the Transactions was approved by the shareholders of the Company at the special meeting of shareholders held on January 4, 2022. As previously announced, Company management will be led by Ryan Smith who will continue to serve as Chief Executive Officer and as a member of the Board of Directors. John Weinzierl will serve as Chairman of the Board of Directors. As part of the transaction, the U.S. Energy Board of Directors increased from five to seven members, including Mr. Weinzierl as Chairman, Mr. Duane King, and Mr. Joshua Batchelor, and four legacy Directors from U.S. Energy, including Mr. Smith. Concurrent with the closing of the Transactions, the Company entered into a new four-year $100 million senior secured credit facility with an initial borrowing base of $15.0 million. The Company will initially have $3.5 million outstanding on the New Credit Facility, representing the assumed indebtedness from the Transactions. The New Credit Facility's opening effective interest rate is expected to be 3.75% per annum.
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CCCC | Hot Stocks07:47 EST C4 Therapeutics sees cash, cash equivalents fund operating's to end of 2024 - Unaudited cash, cash equivalents, and marketable securities as of December 31, 2021 were approximately $450M.
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THRX | Hot Stocks07:46 EST Theseus Pharmaceuticals: First patient treated with THE-630 - Theseus Pharmaceuticals announced that the first patient has been treated in the Phase 1 portion of Theseus' ongoing Phase 1/2 study to evaluate lead candidate, THE-630, in patients with advanced gastrointestinal stromal tumors. Data from the Phase 1/2 clinical trial is expected to inform further clinical development of THE-630 including the design of an initial registrational trial in fifth-line GIST, where there is currently no available therapy and therefore a significant unmet need. THE-630 is also expected to be evaluated in second-line GIST, where a pan-KIT inhibitor with activity against all major classes of activating, or cancer-causing, and resistance mutations has the potential to deliver meaningful clinical benefit over the current standard of care. Initial data from the Phase 1 portion of the clinical trial is expected to be presented at a scientific meeting in the first half of 2023.
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CCCC | Hot Stocks07:46 EST C4 Therapeutics announces key 2022 milestones - C4 Therapeutics announced strategic priorities and 2022 milestones to advance its targeted protein degradation portfolio. STRATEGIC PRIORITIES AND ANTICIPATED 2022 MILESTONES. Advance multiple small molecule oncology degrader programs in the clinic to deliver a new generation of medicines that transforms patients' lives - CFT7455: CFT7455 is a novel degrader targeting IKZF1/3 for the treatment of multiple myeloma and non-Hodgkin's lymphomas. Present initial clinical data from Cohort A of the ongoing Phase 1/2 trial in relapsed or refractory MM and NHL at a medical meeting in 1H 2022; and Progress the CFT7455 Phase 1/2 trial toward identifying a recommended Phase 2 dose for MM and NHL. CFT8634: CFT8634 is a degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors. Initiate a Phase 1 trial in synovial sarcoma and SMARCB1-null solid tumors in 1H 2022. CFT1946: CFT1946 is a mutant-selective degrader of BRAF V600X for the treatment of V600 mutant solid tumors. Submit an investigational new drug application and begin a Phase 1 trial in 2H 2022. CFT8919: CFT8919 is a potent and selective degrader of EGFR L858R for the treatment of NSCLC. Complete IND-enabling activities by year-end 2022. Demonstrate the productivity of TORPEDO platform to advance targeted protein degradation science - At a medical meeting in 1H 2022, C4T plans to present new pre-clinical data across multiple oncology programs: CFT7455 ; CFT8634 ; and CFT1946
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VAXX | Hot Stocks07:46 EST Vaxxinity awarded grant from Michael J. Fox Foundation for UB-312 study - Vaxxinity has announced that the company has been awarded a grant from The Michael J. Fox Foundation for Parkinson's Research for the exploration of markers for target engagement in individuals with Parkinson's disease. Vaxxinity is developing its PD vaccine candidate UB-312, which has completed Part A of a first-in-human study in healthy volunteers and is advancing to Part B in Parkinson's patients. This award from MJFF will support the discovery and development of relevant pharmacodynamic markers. Specifically, the funds will be used to investigate whether Protein Misfolding Cyclic Amplification (PMCA) could be implemented as a robust method to assess target engagement in subjects immunized with UB-312. In recent years, PMCA has demonstrated excellent sensitivity and specificity for the detection of pathological forms of alpha-synuclein in the cerebrospinal fluid of PD patients and has been shown to discriminate accurately between those with synucleinopathies, including PD and Multiple System Atrophy, versus healthy individuals. UB-312 is designed to target pathological forms of aSyn for the treatment and prevention of synucleinopathies, including PD. UB-312 was selected as a clinical candidate through a comprehensive screening and profiling campaign, and demonstrated strong immunogenicity and efficacy in preclinical studies. In the healthy volunteer portion of a first-in-human Phase 1 trial, UB-312 was found to be generally well tolerated at multiple dose levels. Serum and CSF anti-aSyn antibody titers were dose-dependent and indicated that antibodies crossed the blood-brain barrier with a CSF:Serum ratio up to 0.2%. Vaxxinity plans to initiate Part B of the Phase 1 trial later this month to assess the safety, tolerability, and immunogenicity of UB-312 in PD patients. Vaxxinity's senior vice president of preclinical R&D, Jean-Cosme Dodart, PhD, will serve as principal investigator of the exploratory project funded by MJFF.
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PDSB | Hot Stocks07:45 EST PDS Biotechnology granted patent for HPV16 immunotherapy - PDS Biotechnology announced that it has been granted U.S. Patent Application No. 15,724,818 titled "Novel HPV16 Non HLA-Restricted T-cell Vaccines, Composition and Methods of Use Thereof" by the United States Patent and Trademark Office. The newly issued patent covers the PDS0101 immunotherapy which consists of a combination of the Versamune technology platform with a unique mixture of short protein fragments derived from the cancer-causing virus, HPV16. The composition promotes the induction of killer T-cells by the immune system that recognize, and attack cancers caused by infection with HPV16 irrespective of the patients' genetic makeup. HPV16 is the most oncogenic or cancer-causing type of HPV, and is by far the most prevalent in patients with advanced HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal and vulvar cancers. More than 40,500 patients are diagnosed with HPV16-associated cancers each year according to the International Journal of Cancer. Some of these cancers have been reported to be increasing in incidence over the last few years.
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VKTX | Hot Stocks07:45 EST Viking Therapeutics initiates Phase clinical trial of VK2735 - Viking Therapeutics announced the initiation of a Phase 1 single ascending dose and multiple ascending dose clinical trial of VK2735, a novel dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptors. VK2735 is in development for the potential treatment of various metabolic disorders.
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NTRB | Hot Stocks07:44 EST Nutriband in pact with Kindeva Drug Delivery on abuse deterrent fentanyl patch - Nutriband announced the signing of a feasibility agreement with Kindeva Drug Delivery to develop Nutriband's lead product, AVERSA Fentanyl, based on its proprietary AVERSA abuse deterrent transdermal technology and Kindeva's FDA-approved transdermal fentanyl patch . The feasibility agreement is focused on adapting Kindeva's commercial transdermal manufacturing process to incorporate AVERSA technology. Nutriband's AVERSA abuse deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse and accidental exposure of drugs with abuse potential. The technology is covered by a broad intellectual property portfolio with a recent notice of allowance from the United States Patent and Trademark Office, USPTO, and international patents granted in Europe, Japan, Korea, Russia, Mexico, and Australia.
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KYMR | Hot Stocks07:44 EST Kymera Therapeutics announces 2022 goals, milestones - Kymera Therapeutic announced its research and development goals and key milestones for 2022. 2022 Pipeline Objectives: Kymera is discovering and developing novel small molecule therapeutics designed to selectively degrade disease-causing proteins by harnessing the body's own natural protein degradation system, with an initial focus on immune-inflammatory diseases and oncology. IRAK4 Degrader Program: In 2021, Kymera disclosed data from the single ascending dose and multiple ascending dose portions of its Phase 1 randomized, double-blind, placebo-controlled clinical trial in healthy volunteers. The MAD data demonstrated potent, marked IRAK4 reduction in peripheral blood mononuclear cells with steady-state degradation at Day 14 of 92% at the lowest dose level and 96-98% at the two highest dose levels, where IRAK4 was reduced to near the lower limit of quantitation of the assay. Proof of mechanism in the skin was established as mean IRAK4 levels were reduced to near the LLOQ by the final day of dosing on Day 14 at the highest dose level. The continued decline of IRAK4 in skin on Day 14 in the 50-200 mg cohorts suggested that steady-state degradation in skin had not yet been achieved. Proof-of-biology was demonstrated through inhibition of up to 9 disease relevant cytokines with the 100 mg dose reaching 85% inhibition. KT-474 multi-dosing was safe and well-tolerated. Kymera has now completed dose escalation in the SAD and MAD healthy volunteer portions of KT-474's Phase 1 clinical trial and will review all clinical data prior to initiating the open-label patient portion of the study. Expected 2022 Milestones: Commence patient dosing of Phase 1 trial; Present data from patient cohort showing proof of mechanism and proof of biology; Kymera is collaborating with Sanofi on the development of degrader candidates targeting IRAK4, including KT-474 , outside of the oncology and immune-oncology fields. IRAKIMiD Degrader Program: In 4Q21, Kymera announced IND clearance of KT-413, the company's potent degrader of IRAK4 and IMiD substrates. KT-413's Phase 1 trial will evaluate safety, PK/PD, and preliminary efficacy in MYD88 mutant and MYD88 wild-type relapsed/refractory Diffuse Large B-Cell Lymphoma. Primary study endpoints will include safety, tolerability and recommended Phase 2 dose, with secondary endpoints of PK and preliminary efficacy. The trial will also explore target knockdown and downstream effects in PBMC and tumors. Expected 2022 Milestones: Present first proof of mechanism clinical data to de-risk further development; Present new preclinical data to enable indication expansions in new oncology indications. STAT3 Degrader Program: In 4Q21, Kymera announced IND clearance of KT-433, the company's potent degrader of STAT3. KT-333's Phase 1 trial will evaluate safety, PK/PD, and preliminary efficacy in peripheral T cell lymphoma, cutaneous T cell lymphoma, large granular lymphocytic leukemia and solid tumors. Primary study endpoints will include safety, tolerability and recommended Phase 2 dose, with secondary endpoints of PK and preliminary efficacy. The trial will also explore STAT3 knockdown and downstream effects in PBMC and tumors. Expected 2022 Milestones: Present first proof of mechanism clinical data to de-risk further development; Present new preclinical data to enable indication expansions in new oncology indications; Present new preclinical data to demonstrate relevance of STAT3 degradation in immunology and fibrosis. MDM2 Degrader Program: At last month's R&D Day, Kymera announced its new development program and development candidate, KT-253, a potent and selective degrader of MDM2 with potential to be a best-in-class P53 stabilizer. Degradation of MDM2, rather than inhibition, has the ability to block the feedback loop which up-regulates MDM2 production and in doing so more effectively drives tumor cells to rapid apoptosis. KT-253 inhibits tumor cell growth with picomolar potency that is more than 200-fold greater than clinically active MDM2 small molecule inhibitors. This leads to sustained tumor regression in vivo in leukemia models following just a single dose. As wild-type p53 is present in greater than50% of tumors, KT-253 represents another program with broad franchise potential in liquid and solid tumors. Kymera is focused on indications with specific sensitivity to this mechanism of action, such as AML, lymphomas, uveal melanoma and others through a focused biomarker strategy. Expected 2022 Milestones: Present additional preclinical data that outline the biomarker strategy as well as new indications for KT-253;File IND for KT-253; Discovery and Platform. Kymera is also actively advancing a broad pipeline of preclinical programs across a wide variety of diseases, both internally and in collaboration with existing partners Vertex Pharmaceuticals and Sanofi. The internal programs continue to be focused on undrugged or inadequately drugged nodes within highly validated pathways. Kymera is committed to drugging all high value target classes in human cells in a technology- and disease-agnostic manner with particular focus on using tissue-selective or -restricted E3 ligase and molecular glue degraders where needed to elicit the best clinical response. Key 2022 Objectives: Nominate first Development Candidate using a tissue restricted E3 ligase; Continue pipeline expansion by advancing early-stage discovery programs toward IND-enabling studies; Further expand the capabilities of Kymera's Pegasus platform to identify the optimal pairing of disease-causing protein targets with E3 ligases to generate novel degrader product candidates; Leverage Kymera's E3 Ligase Whole-Body Atlas of over 600 unique E3 ligases to identify previously unliganded E3 ligases, including tissue-restricted or -selective, as well as new small molecule molecular glue degraders to unlock new opportunities across broad therapeutic applications. 2022 Corporate Objectives: Kymera's mission is to discover, develop, and commercialize transformative therapies while leading the evolution of targeted protein degradation. The Company's goal is to become a fully integrated biopharmaceutical company with a pipeline of novel medicines targeting disease-causing proteins that were previously intractable. In 2022, Kymera plans to continue to grow and strengthen its organizational capabilities in order to deliver on the potential of inventing a new class of protein degrader medicines for patients.
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SOPH NVS | Hot Stocks07:44 EST Sophia Genetics names Abhimanyu Verma as Chief Technology Officer - Sophia Genetics (SOPH) announced key additions to their leadership team with the hiring of Peter Casasanto as Chief BioPharma Officer and Abhimanyu Verma as Chief Technology Officer. The additions are part of Sophia Genetics' strategy to enhance its business in the pharmaceutical industry. Peter and Abhi will help the company drive deeper with a focus on leveraging data for the BioPharma industry. Previously, Abhi served at Novartis (NVS) where he had several leadership roles spanning multiple functions, locations and therapy areas in applied technology innovation, real world evidence, drug development, enterprise technologies, IT strategy, data science and AI. He incubated and scaled several technology and data centric platforms, products and capabilities that underpin the digital transformation at Novartis. The early part of his career was spent at GE and Patni Computers.
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AVXL | Hot Stocks07:43 EST Anavex reports results from Phase 1 trial of ANAVEX 3-71 - Anavex Life Sciences announced "positive" top-line results from its Phase 1 clinical trial of ANAVEX 3-71, an oral small molecule agonist of both SIGMAR1 and CHRM1 in development for the treatment of neurodegenerative diseases including Frontotemporal Dementia, FTD, for which ANAVEX 3-71 has been granted Orphan Drug Designation, ODD, by the FDA. The study was a double-blind, randomized, placebo-controlled, Phase 1 trial to evaluate safety and tolerability, and pharmacokinetics of oral escalating doses of ANAVEX 3-71 including effects of food and gender in healthy volunteers. ANAVEX(R)3-71 was well tolerated in all cohorts receiving ANAVEX 3-71 in single doses ranging from 5 mg to 200 mg daily with no serious adverse events, SAEs, and no significant lab abnormalities in any subject. In the study, ANAVEX 3-71 exhibited linear pharmacokinetics. Gender had no effect on the PK of the drug and food had no effect on the bioavailability of ANAVEX(R)3-71. The study also met the secondary objective of characterizing the effect of ANAVEX 3-71 on electrocardiogram, ECG, parameters. There were no clinically significant ECG parameters throughout the study. Based on these results, and ANAVEX 3-71 pre-clinical profile, the Company intends to advance ANAVEX 3-71 into a biomarker-driven clinical development dementia program for the treatment of FTD, schizophrenias and Alzheimer's disease, evaluating longitudinal effect of treatment with ANAVEX 3-71 initiating in 2022.
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USAP | Hot Stocks07:40 EST Universal Stainless & Alloy announces base price increase on all products - Universal Stainless & Alloy Products announced a base price increase of 3% to 10% on all products. The increase goes into effect immediately for all new orders. Current material and energy surcharges will remain in effect.
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FULC | Hot Stocks07:40 EST Fulcrum Therapeutics expects cash to fund requirements into 2024 - As of December 31, 2021, Fulcrum's cash, cash equivalents and marketable securities were $218.2 million. Based on its current operating plans, the company believes this is sufficient to fund its anticipated operating expenses and capital expenditure requirements into 2024.
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FULC BPMC | Hot Stocks07:39 EST Fulcrum Therapeutics appoints Kate Haviland as chair of the board - Fulcrum also announced that Kate Haviland, chief operating officer and incoming chief executive officer of Blueprint Medicines, has been named chair of Fulcrum's board of directors. Ms. Haviland has been a member of Fulcrum's board since 2018. As part of a planned transition, she is succeeding Mark Levin. Mr. Levin is a partner at Third Rock Ventures and has served on Fulcrum's board of directors since the company's founding in 2015 and as chair of the board since 2016. Mr. Levin will remain on the board through April 18, 2022.
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FULC | Hot Stocks07:39 EST Fulcrum Therapeutics announces upcoming milesones - Fulcrum Therapeutics outlined its recent accomplishments and expected upcoming milestones. Fulcrum will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on Thursday, January 13 at 12:00 p.m. ET."Fulcrum made substantial progress in 2021, positioning us for a transformative 2022," said Bryan Stuart, president and chief executive officer. "Our clinical results with losmapimod highlight its potential to slow or stop the progression of FSHD, a relentless form of muscular dystrophy that leads to loss of upper body function and mobility and for which there are no treatments. We also reported results from our clinical program with FTX-6058, supporting its potential to be a functional cure for sickle cell disease. Based on these results, we are intently focused on advancing this oral HbF inducer for people with sickle cell disease as well as other hemoglobinopathies. As we enter 2022, we are building on this progress, with multiple milestones expected across our clinical and discovery-stage pipeline," Mr. Stuart continued. "We plan to provide an update on losmapimod in the first quarter. I'm also pleased to share that we enrolled the first patient with sickle cell disease in our Phase 1b trial, putting us on track to report initial data in the second quarter of 2022. We also submitted an IND for FTX-6058 in select hemoglobinopathies and expect to start a Phase 1b trial in the second quarter of 2022. In parallel, we continue to advance our FulcrumSeek product engine and plan to nominate our next development candidate this year to support an IND by the end of the first quarter of 2023." Recent Accomplishments: Dosed first sickle cell disease patient in the Phase 1b clinical trial of FTX-6058, an oral fetal hemoglobin inducer. Completed three-month preclinical toxicology studies and initiated chronic toxicology studies to advance FTX-6058 in multiple indications. Submitted Investigational New Drug application to initiate clinical development of FTX-6058 in select hemoglobinopathies, including beta-thalassemia. Announced the appointment of Esther Rajavelu as Chief Financial Officer. Expected Milestones: Losmapimod: Provide an update in the first quarter of 2022 on plans for a Phase 3 clinical trial of losmapimod in facioscapulohumeral muscular dystrophy. FTX-6058: Report initial data, including measures of HbF protein induction, from the Phase 1b trial in people with sickle cell disease in the second quarter of 2022. Initiate Phase 1b trial in select hemoglobinopathies, including beta-thalassemia, in the second quarter of 2022. Initiate registrational trial in sickle cell disease in early 2023. Preclinical Pipeline: Nominate next development candidate by end of 2022 to support the company's fourth IND by the end of the first quarter of 2023.
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HZNP | Hot Stocks07:39 EST Horizon Therapeutics submits sBLA for concomitant use of KRYSTEXXA in gout - Horizon Therapeutics announced that it has submitted a supplemental Biologics License Application, sBLA, to the U.S. Food and Drug Administration, FDA, to expand the approved indication for KRYSTEXXA plus methotrexate, an immunomodulator commonly prescribed by rheumatologists. "Horizon has invested substantially in research and development efforts to improve the safety and efficacy of KRYSTEXXA in the various patient populations who are affected by uncontrolled gout," said Theresa Podrebarac, M.D., M.Sc., senior vice president, clinical development, Horizon. "We are committed to actively advancing research and addressing the long-term consequences for this often overlooked, stigmatized disease. Since 2018, we have seen a paradigm shift in uncontrolled gout care, which has been reinforced by the positive MIRROR randomized controlled trial results. Today's filing reflects these trends and will help to further evolve the standard of care in uncontrolled gout."...The sBLA seeks to update the prescribing information to include KRYSTEXXA plus methotrexate to help more patients achieve a complete and durable response to therapy by decreasing the development of anti-drug antibodies. Horizon expects the FDA to complete its review during the second half of 2022.
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SGRY | Hot Stocks07:38 EST Surgery Partners appoints David Doherty as Chief Financial Officer - The Company announced that David Doherty, Senior Vice President, Corporate Finance and Controller at Surgery Partners, will assume the role of Chief Financial Officer, effective February 1, 2022. Tom Cowhey will be transitioning from his role as Chief Financial Officer to pursue a new opportunity. To ensure a smooth transition, Cowhey has agreed to remain with the Company through the end of February.
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FHTX | Hot Stocks07:37 EST Foghorn Therapeutics appoints Steven Bellon to CSO - Foghorn announced Steven Bellon, Ph.D., currently Senior Vice President of Drug Discovery, is promoted to Chief Scientific Officer, effective today, January 10, 2022. Carl Decicco, Ph.D., is retiring from his role as Chief Scientific Officer at Foghorn.
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EYPT | Hot Stocks07:36 EST EyePoint names Michael Pine as chief corporate development, strategy officer - EyePoint Pharmaceuticals announced the appointment of Michael Pine as Chief Corporate Development and Strategy Officer. Most recently, Mr. Pine was a Senior Vice President of Business Development and Strategy at Medexus Pharmaceuticals, where he identified, evaluated and executed several transactions critical to the growth of the organization. In connection with the hiring of Mr. Pine, the Compensation Committee of Eyepoint Pharmaceutical's Board of Directors granted stock options to purchase an aggregate of 100,000 shares of common stock as an inducement award material to Mr. Pine entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price equal to the closing price of EyePoint's common stock on January 10, 2022, and will vest as follows: 25% on the first anniversary and monthly through the fourth anniversary of the date of grant, subject to the terms of grant.
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HLLY | Hot Stocks07:35 EST Holley completes acquisition of brands during Q4 for approximately $56M - Holley announced it has acquired substantially all of the assets of Arizona Desert Shocks , Baer Brakes, Brothers Trucks, and Rocket Racing Wheels during the fourth quarter of 2021. "We are excited to welcome Arizona Desert Shocks, Baer Brakes, Brothers Trucks, and Rocket Racing Wheels to the Holley family of enthusiast brands," said Tom Tomlinson, Holley's President and CEO. "These acquisitions are in highly strategic product categories that are powertrain agnostic with applicability to the emerging opportunity in electric vehicles and electric powertrain conversions. The acquisition of ADS augments Holley's existing capabilities in on-road performance suspension systems by adding off-road expertise. Baer Brakes introduces a new product category to Holley and brings us tremendous brake system expertise, moving us closer to our goal of providing complete vehicle solutions to our enthusiast consumers. Brothers Trucks further enhances our offerings in truck and SUV appearance items and Rocket Racing Wheels strengthens our offerings in wheels for both cars and trucks." "These acquisitions reflect our commitment to invest strategically to broaden and diversify Holley's range of performance products, focusing on vehicle platforms our enthusiast consumers love," said Vinny Nimmagadda, Holley's Executive Vice President of Corporate Development & New Ventures. "Importantly, we believe they help unlock and expand new and large addressable markets of strategic importance to the Company." Holley completed these acquisitions for approximately $56M during the fourth quarter of 2021. The transactions were financed through a combination of cash on hand and Holley's new credit facility. For 2022, Holley expects these acquisitions to contribute net sales of approximately $30M.
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JAZZ | Hot Stocks07:35 EST Jazz Pharmaceuticals announces $5B revenue target for 2025 - Jazz Pharmaceuticals announced its Vision 2025 to deliver sustainable growth and enhanced value. Vision 2025 includes the following expectations: 1) generating $5B in revenue in 2025; 2) approval of at least five additional novel products by the end of the decade; and 3) realizing a 5% adjusted operating margin improvement from 2021 to 2025, driven by operational excellence. The company also confirmed that it expects to meet its previously announced 2021 revenue guidance range of $3.02B-$3.1B and its net product sales guidance for neuroscience and oncology. Jazz ended 2021 demonstrating executional excellence across its business, including launching five key products in 2020 and 2021, integrating the GW Pharmaceuticals business, making progress towards its deleveraging target and initiating multiple potentially registrational clinical trials. The company remains on track to deliver revenue diversification, with at least 65% of 2022 net product revenue from newly launched or acquired products, driving sustainable growth and enhanced shareholder value. "Building on our track record of strong execution and guided by our patient-centric approach, Jazz is setting forth its Vision 2025 to deliver meaningful treatment options to patients, a great place to work for employees and significant value to shareholders," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "Jazz's leadership in sleep and rare epilepsy with Xywav and Epidiolex, respectively, coupled with promising new oncology products like Zepzelca and Rylaze, have led to the rapid transformation of our revenue base. We are further poised to enter new disease areas with serious unmet patient need and substantial market potential, including movement disorders and PTSD, with our mid-to late-stage assets nabiximols, suvecaltamide and JZP150. We expect our continued operational excellence to drive a five-percentage point improvement in our adjusted operating margin from 2021 to 2025, and we are confident in our ability to continue to leverage strategic capital allocation to grow our business."
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GLMD | Hot Stocks07:32 EST Galmed announces 'positive' results from Phase 1 study of Amilo-5MER - Galmed Pharmaceuticals announced results of a Phase 1 clinical trial of Amilo-5MER in healthy volunteers that demonstrated an excellent safety profile and tolerability. The safety, tolerability, and pharmacokinetics of single and multiple doses of Amilo-5MER were assessed in a first-in-human study in healthy subjects. The Phase I study was conducted in a single-center, using a double-blind, randomized, placebo-controlled design. Overall, 64 healthy male and female subjects were enrolled in the study. Cohorts of 8 subjects were randomized to receive Amilo-5MER or placebo by subcutaneous injection in a ratio of 6:2. In Part 1, cohorts of young male adults received single ascending doses of 10, 30, 90, 180 and 360 mg; in Part 2, a single cohort received doses of 180 mg BID for 5 consecutive days and in Part 3 a single cohort of healthy elderly male and female subjects received a single dose of 180 mg. All doses of Amilo-5MER were well tolerated with no clinically significant adverse events and none considered related to the investigational product. All subjects completed the study as per protocol. Plasma concentrations of Amilo-5MER increased in proportion to dose. "We are excited to bring Amilo-5MER into the clinical phase and look forward to advancing our product pipeline to address additional important indications for the benefit of patients around the world," noted Allen Baharaff, President and CEO of Galmed. Galmed is developing Amilo-5MER for multiple routes of administration and multiple indications. The company plans to submit an IND for mild to moderate ulcerative colitis in 2022.
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KPTI ARWR | Hot Stocks07:28 EST Karyopharm names Sohanya Cheng as Chief Commercial Officer - Karyopharm Therapeutics (KPTI) announced that Sohanya Cheng has been promoted to Chief Commercial Officer. She will be responsible for leading the company's commercial strategy and operations, including the continued commercialization of XPOVIO. Cheng joined Karyopharm in 2021 as Senior Vice President of Sales and Commercial Operations. Prior to joining Karyopharm, she served as Vice President, Head of Marketing and Corporate Affairs at Arrowhead Pharmaceuticals (ARWR).
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JYNT | Hot Stocks07:27 EST Joint Corp. performed 10.9M patient visits in 2021 - The Joint Corp. provided operating metrics for the year ended 2021. Performed 10.9 million patient visits, up from 8.3 million in 2020 and 7.7 million in 2019. Treated 807,000 new patients, up from 584,000 in 2020 and 585,000 in 2019. Increased system-wide sales 39%, up from 18% in 2020 and from 33% in 2019. Delivered comp sales of 29%, up from 9% in 2020 and 25% in 2019. Sold 156 franchise licenses, compared to 121 in 2020 and 126 in 2019. Grew total clinics to 706 at December 31, 2021, 610 franchised and 96 company-owned or managed, up from 579 at December 31, 2020. During 2021, the company acquired 12 franchised clinics and closed 3 clinics. It also opened 110 franchised and 20 corporate greenfield clinics, for a total of 130 new clinics in 2021, as compared to 73 new clinics opened in 2020 and 76 in 2019. "We are proud of our doctors, wellness coordinators, entire community of franchisees, and corporate staff who consistently work to achieve our mission of improving quality of life through routine and affordable chiropractic care," stated Peter D. Holt, President and Chief Executive Officer of The Joint Corp. "Once again, they rose to the occasion, delivering record breaking operational performance in 2021. In 2022, we plan to accelerate our clinic opening momentum as we march toward our goal of 1,000 clinics opened by the end of 2023."
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REPL | Hot Stocks07:27 EST Replimune Group provides anticipated milestones for 2022 - Replimune Group provided a corporate update, highlighting the progress of key programs. Anticipated Key Milestones for 2022: CERPASS - Registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma: The Company is actively enrolling patients in a Phase 2 clinical trial evaluating RP1 in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company expects to complete enrollment such that the trigger for the primary data analysis is expected in late 2022. IGNYTE - Multi-cohort Phase 2 clinical trial of RP1 combined with Opdivo: Anti-PD-1 failed melanoma cohort: The Company continues to enroll patients in the IGNYTE Phase 2 clinical trial. The company expects to release interim data from this cohort in late 2022. Non-melanoma skin cancer cohort: The Company remains on track to provide updated data from the anti-PD1 naive patients and initial data from the anti-PD-1 failed patients in the first quarter of 2022. Anti-PD-1 failed non-small cell lung cancer cohort: Enrollment is open, with initial data is expected to be released in late 2022. ARTACUS - Phase 1b/2 clinical trial of RP1 as monotherapy in solid organ transplant recipients with CSCC: Enrollment continues in this trial. The Company remains on track to present initial data from this clinical trial in the first quarter of 2022. RP2 and RP3 : RP2 alone and in combination with Opdivo in difficult-to-treat cancers: The Company initiated its expansion of the Phase 1 clinical trial of RP2 in combination with Opdivo. The company expects to present initial data from the expansion patients in late 2022. RP3 alone and in combination with Opdivo: The Company is enrolling patients in a Phase 1 clinical trial for RP3, with initial data expected to be presented in the first quarter of 2022. The company expects to present initial data from the expansion patients in late 2022. RP2 and/or RP3 next stage development including in patients with liver metastases from a range of tumor types: The Company remains on track to initiate a broad clinical development program with RP2 and/or RP3 around mid-year 2022.
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FWRG | Hot Stocks07:26 EST First Watch Restaurant sees 2021 same restaurant traffic growth up 63%
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OMGA | Hot Stocks07:26 EST Omega Therapeutics names Yan Moore, M.D., as Chief Medical Officer - Omega Therapeutics announced the appointment of Yan Moore, M.D., as Chief Medical Officer. Dr. Moore has extensive management, research, translational drug development and medical affairs experience across various pharmaceutical and biotechnology companies. Dr. Moore most recently served as Senior Vice President, Head of Oncology Therapeutic Area at Ipsen Pharmaceuticals where he focused on scientific and development strategy as well as identifying and executing on research and development objectives in the areas of oncology and immune-modulatory therapies.
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FWRG | Hot Stocks07:26 EST First Watch Restaurant sees Q4 same restaurant traffic growth up 36.7% - First Watch Restaurant Group reported certain preliminary operational results for the thirteen weeks ended December 26, 2021 and fiscal year ended December 26, 2021: "We are proud to share these preliminary results from First Watch's fourth quarter. Our 36.7% same-restaurant sales growth is driven by more than 30% same-restaurant traffic growth, building upon the 28 consecutive quarters of positive same-restaurant sales we achieved prior to the pandemic, from fiscal 2013 to fiscal 2019," said Chris Tomasso, Chief Executive Officer and President of First Watch. "Our continued strong performance is possible because of the dedication of our operations teams throughout the country, whose resilience and gracious service are reflected in these results." First Watch opened 8 system-wide restaurants during the fourth quarter, consisting of 5 company-owned restaurants and 3 franchise-owned restaurants. In addition, during the quarter the Company accelerated the planned closure of a 30-year-old company-owned restaurant. There were 31 system-wide restaurant openings during fiscal 2021, consisting of 22 company-owned restaurants and 9 franchise-owned restaurants. At December 26, 2021, First Watch had 435 system-wide restaurants, consisting of 341 company-owned restaurants and 94 franchise-owned restaurants across 28 states. Updated Outlook: Based upon the preliminary same-restaurant sales growth noted above and considering certain end-of-year expenses, management expects Adjusted EBITDA*** to be slightly above the high-end of the previously announced Adjusted EBITDA range of $10.2 million to $11.2 million for the fourth quarter.
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CLVT | Hot Stocks07:24 EST Clarivate names Gordon Samson as Chief Product Officer - Clarivate announced that as part of its One Clarivate Vision to put even greater focus on its customers and solutions, effective February 1, Gordon Samson will become Chief Product Officer. Samson, who is currently President of the IP Segment, will support the four Clarivate customer verticals in this newly created and focused role. With this change, Mukhtar Ahmed, President of the Science Segment, will be leaving the company. Ahmed will work with Samson on the transition of the Science team and the ProQuest integration until April 1, 2022, then will remain in an advisory role to the company until his departure on October 1, 2022.
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TTWO ZNGA | Hot Stocks07:24 EST Take-Two to acquire Zynga for $9.86 per share - Take-Two (TTWO) and Zynga (ZNGA) announced that they have entered into a definitive agreement, under which Take-Two will acquire all of the outstanding shares of Zynga in a cash and stock transaction valued at $9.86 per Zynga share, based on the market close as of January 7, with a total enterprise value of approximately $12.7B. Under the terms and subject to the conditions of the agreement, Zynga stockholders will receive $3.50 in cash and $6.36 in shares of Take-Two common stock for each share of Zynga common stock outstanding at the closing of the transaction. The purchase price represents a premium of 64% to Zynga's closing share price on January 7. The combined entity has significantly greater scale, with $6.1B in net bookings, and $769M in adjusted unrestricted operating cash flow on a pro-forma basis for the trailing twelve-month period ended September 30, 2021. Looking ahead, the combined company is expected to deliver a 14% compound annual growth rate for net bookings over the three-year period from Take-Two's FY21 through FY24. Zynga stockholders will receive $3.50 in cash and $6.361 in shares of Take-Two common stock for each share of Zynga common stock outstanding at the closing. The transaction is valued at $9.861 per share of Zynga common stock based on the market closing as of January 7, 2022, implying an enterprise value of approximately $12.7B. The transaction includes a collar mechanism on the equity consideration, so that if Take-Two's 20-day volume weighted average price ("VWAP") ending on the third trading day prior to closing is in a range from $156.50 to $181.88, the exchange ratio would be adjusted to deliver total consideration value of $9.86 per Zynga share (including $6.36 of equity value based on that VWAP and $3.50 in cash). If the VWAP exceeds the higher end of that range, the exchange ratio would be 0.0350 per share, and if the VWAP falls below the lower end of that range, the exchange ratio would be 0.0406 per share. Within the collar range, the final number of Take-Two shares estimated to be issued on a fully diluted basis will range between approximately 50.3 million and 58.5 million shares. Upon closing of the transaction, current Take-Two stockholders will own between 67.2% and 70.4% and current Zynga stockholders are expected to own between 29.6% and 32.8% of the combined company on a fully diluted basis, respectively, including the shares associated with expected settlement of Zynga's two outstanding series of convertible notes due 2024 and 2026. As part of the transaction, Take-Two has received committed financing of $2.7B from J.P. Morgan and intends to fund the cash component of the transaction through a combination of cash from its balance sheet as well as proceeds of new debt issuance. The merger agreement provides for a "go-shop" provision under which Zynga and its board of directors may actively solicit, receive, evaluate, and potentially enter negotiations with parties that offer alternative proposals during a 45-day period following the execution date of the definitive agreement, expiring on February 24. There can be no assurance this process will result in a superior proposal. Zynga does not intend to disclose developments about this process unless and until its board of directors has made a decision with respect to any potential superior proposal.
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FOLD | Hot Stocks07:23 EST Amicus provides updates, anticipated milestones by program - Amicus Therapeutics provided its corporate updates, and full-year 2022 outlook. Updates and Anticipated Milestones by Program: Galafold Oral Precision Medicine for Fabry Disease: Sustain double-digit revenue growth in 2022 of $350M-$365M; Continue geographic expansion; and Registry and other Phase 4 studies ongoing. AT-GAA for Pompe Disease: U.S. Prescription Drug User Fee Act action date of May 29, 2022 for the NDA and July 29, 2022 for the BLA; EU Committee for Medicinal Products for Human Use opinion expected in late 2022; Continue to broaden access through early access plans in the U.K., Germany, Japan, and other countries; and Ongoing supportive studies, including pediatric and extension studies. Gene Therapy Pipeline: Advance IND-enabling studies, manufacturing activities, and regulatory activities for the Fabry disease gene therapy program towards an anticipated IND in 2023; Progress preclinical studies, manufacturing activities, and regulatory activities for the Pompe disease gene therapy program; Discontinue CLN6 Batten disease gene therapy program following review of long-term extension study data. It was recently determined that any initial stabilization of disease progression at the two-year time point was not maintained through the long-term extension study; Advance CLN3 Batten disease program with the higher dose, different promoter, and intra-cisterna magna route of delivery pending further Phase 1/2 clinical data and pre-clinical data expected in 2022. These data will inform timeline for commencement of any pivotal clinical study
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SELB DNA | Hot Stocks07:19 EST Selecta Biosciences, Ginkgo Bioworks announced collaboration - Selecta Biosciences (SELB) and Ginkgo Bioworks (DNA) announced a collaboration to develop safer and more effective next-generation gene therapy viral capsids. This partnership leverages the unique platforms of both companies as they seek to develop next-generation viral capsids with improved transduction, enhanced tissue tropism and reduced immunogenicity. Ginkgo plans to design and engineer the capsids and Selecta will conduct all pre-clinical and clinical studies thereafter. Under the terms of the collaboration, Ginkgo is eligible to earn upfront research and development fees and milestone payments, including certain milestone payments in the form of Selecta common stock. In addition, Ginkgo is eligible to earn clinical, regulatory and commercial milestone payments of up to $200M in cash for each of a specified number of products, which have the potential to total, in the aggregate, up to $1.1B. Ginkgo is also entitled to potential further downstream value in the form of royalties on sales.
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TLRY | Hot Stocks07:18 EST Tilray reports synergies from Aphria combination $70M on run-rate basis to date - Cost synergies from Aphria-Tilray combination of $70 million achieved on a run-rate basis to date, with actual cash-savings close to $36 million to date. Expect to reach $80 million synergy target, ahead of schedule, by May 31, 2022 and to generate an additional $20 million in synergies in fiscal 2023.
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TLRY | Hot Stocks07:18 EST Tilray announces new parent company name Tilray Brands - The Company also announced a new parent name, Tilray Brands, Inc., reflecting the Company's evolution from a Canadian LP to a global consumer packaged goods company powerhouse with a market leading portfolio of cannabis and lifestyle CPG brands.
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KPTI | Hot Stocks07:17 EST Karyopharm sees Q4 net product revenues of XPOVIO $29.7M - Karyopharm Therapeutics announced preliminary unaudited fourth quarter and full year 2021 net product revenue estimates for XPOVIO, the company's first-in-class, oral XPO1 inhibitor. Based on preliminary unaudited financial information, Karyopharm expects net product revenues of XPOVIO to be approximately $29.7M for the fourth quarter and approximately $98.3M for the full year 2021. Q4/FY21 revenue consensus is $30.88M/$114.03M, respectively. "For 2022, we are focused on making significant advances across our pipeline, beginning with top-line results from the Phase 3 SIENDO study evaluating selinexor as a maintenance therapy following front-line chemotherapy in patients with advanced or metastatic endometrial cancer, which remain on track to be reported this quarter," said Richard Paulson, President and CEO of Karyopharm. "Building on the strong revenue growth in the second half of 2021, we will continue to prioritize driving sales and the adoption of XPOVIO in multiple myeloma. I am extremely pleased with the continued progress of our pipeline in key additional indications of multiple myeloma, myelodysplastic syndromes and myelofibrosis and our ability to further expand our impact on patients globally with our recent partnership with Menarini."
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AGIO | Hot Stocks07:17 EST Agios Pharmaceuticals announces anticipated 2022, five year milestones - Agios Pharmaceuticals announced its anticipated 2022 key milestones and priorities. Anticipated 2022 Key Milestones & Priorities: Agios expects to execute on the following key milestones and priorities in 2022: Pyruvate Kinase Deficiency: Receive U.S. Food and Drug Administration regulatory decision for mitapivat in adults with PK deficiency in Q1; receive European Medicines Agency regulatory decision for mitapivat in adults with PK deficiency by year-end; Initiate Phase 3 ACTIVATE-kids and ACTIVATE-kidsT studies of mitapivat in mid-2022. Thalassemia: Enrollpatients in the Phase 3 ENERGIZE and ENERGIZE-T studies of mitapivat by year-end. Sickle Cell Disease: Complete enrollment in the Phase 2 portion of the RISE UP study of mitapivat in sickle cell disease by year-end; Initiate the sickle cell disease cohort of the Phase 1 study of novel PK activator AG-946 in the first half of 2022. Expansion and Acceleration of PK Activation Portfolio: Initiate Phase 2a study of AG-946 in adults with low- to intermediate-risk myelodysplastic syndrome by year-end; Continue to publish clinical and translational data supporting the utility of PK activators across key disease areas and elucidating the burden of disease for PK deficiency, thalassemia and sickle cell disease. Agios Five-Year Strategic Vision: The Agios five-year strategic vision reflects the company's expected evolution as a leader in developing genetically defined disease therapies based on its scientific expertise in cellular metabolism. As part of this vision, Agios expects to achieve the following milestones by the end of 2026: Receive regulatory approvals globally for mitapivat in three initial indications: adult PK deficiency, thalassemia and sickle cell disease; Advance a broad clinical pipeline of at least 5 molecules exploring at least 10 indications; Foster a robust research pipeline poised to deliver an investigational new drug every 12-24 months; and Achieve cash-flow positivity
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FXLV | Hot Stocks07:15 EST F45 Training sees Q4 SSS up 6% globally, up 53% in U.S. - Preliminary expected results for Q4: Same store sales increased by 6% globally and 53% in the United States. System-wide sales increased by 27% globally and 95% in the United States. System-wide visits increased by 7% globally and 50% in the United States. Net new studio openings totaled approximately 130 compared to 61 in the prior year period. Net new franchises sold totaled approximately 275 compared to 30 in the prior year period.
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NMG | Hot Stocks07:13 EST Nouveau Monde appoints Bernard Perron to COO - Nouveau Monde announced the appointment of Bernard Perron to the position of COO starting Monday, January 17. Perron will oversee Nouveau Monde's engineering, procurement, construction, operations, as well as environmental, health and safety, or EH&S, management for its integrated mine-to-battery-material business model. A senior executive with over 25 years of experience in the energy infrastructure sector, Perron has completed over $8B in projects in the last ten years with EH&S performance. Prior to joining Nouveau Monde, Perron acted as senior VP, project development and operations services, at Inter Pipeline.
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DISCA... | Hot Stocks07:12 EST Discovery Inc. to become minority owner of OpenAP - OpenAP and Discovery (DISCA, DISCB) announced that Discovery will become a minority owner of OpenAP, the advanced advertising company bringing simplicity and scale to audience-based campaigns in television. Discovery joins FOX (FOX, FOXA), NBCUniversal and ViacomCBS (VIAC) in the joint venture. The investment signals an expansion of Discovery's existing relationship with OpenAP, having integrated with the central TV identity spine, OpenID, in April 2021 and more recently partnering with OpenAP on the launch of XPm, the TV publisher backed cross-platform measurement framework. The commitment to OpenAP furthers Discovery's strategy of building a technical framework that enables cross-platform audience-based buying and creating collaborative support for alternative currency standards. For OpenAP, it will help further its ability to grow the overall market for audience-based advertising and expand the breadth and scale of its services across cross-platform identity, measurement and planning.
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NBRV | Hot Stocks07:12 EST Nabriva Therapeutics provides business update - Nabriva Therapeutics announced a business update. In 2022, the company looks for continued growth through execution on key milestones including: Growing SIVEXTRO sales to historical levels by mid-2022; Pulling through hospital transition of care opportunity for XENLETA with Vizient Health; Enrolling the first patient in our Phase I CF trial in the first quarter; Geographic expansion of commercialization and distribution partnerships for lefamulin in the EU and the rest of the world; Continuing to work with FDA to bring CONTEPO to market in the U.S.; and Assessing other business development opportunities to add to our product portfolio and leverage current infrastructure
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BCRX | Hot Stocks07:12 EST BioCryst says BCX9930 pivotal trials in PHN now enrolling - BioCryst is currently enrolling patients in two global pivotal trials, REDEEM-1 and REDEEM-2, with the company's oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria. The company also has begun screening patients in a proof of concept basket trial of BCX9930 (500 mg bid) in patients with C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy (PMN). BioCryst plans to further advance and expand its Factor D program over the next two years by achieving the following: Complete and report data from REDEEM-1 and REDEEM-2 Prepare to submit regulatory approval filings in PNH Complete the renal PoC basket trial and advance to pivotal trials in C3G, IgAN and PMN Commence PoC trials in other complement-mediated diseases "Following the discovery, development and commercialization of ORLADEYO, the BioCryst team plans to repeat this success as we leverage our platform to bring new oral medicines to patients suffering from other rare diseases. BCX9930 is especially exciting because the clinical data we have reported so far provides confidence that we can help patients in PNH, and across many complement-mediated diseases, with this pipeline in a molecule," said Dr. Helen Thackray, chief research and development officer of BioCryst.
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TAK | Hot Stocks07:09 EST Takeda Pharmaceutical to acquire Adaptate Biotherapeutics - Takeda Pharmaceutical announced the exercise of its option to acquire Adaptate Biotherapeutics, a UK company focused on developing antibody-based therapeutics for the modulation of variable delta 1 gamma delta T cells. Through the acquisition, Takeda will obtain Adaptate's antibody-based T cell engager platform, including pre-clinical candidate and discovery pipeline programs. Adaptate's T cell engagers are designed to specifically modulate T cell-mediated immune responses at tumor sites while sparing damage to healthy cells. The planned acquisition of Adaptate follows Takeda's recently exercised option to acquire GammaDelta Therapeutics and is intended to further accelerate the development of innovative T cell-based therapies. Combining GammaDelta's cell therapy-based platform and Adaptate's antibody-based T cell engager platform with Takeda's strong research and development organization positions Takeda to be at the leading edge in deploying the full potential of T cells in the fight against cancer. The planned acquisition complements Takeda's ongoing efforts to research and develop cell engagers for solid tumor applications, bolstered by the novel T cell engager Cobra platform, which was acquired from Maverick Therapeutics in another build-to-buy collaboration.
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GATO | Hot Stocks07:09 EST Gatos Q4 silver production up 35% to 2.3M ounces in Q4 from Q3 - Gatos Silver is very pleased to report record silver production and plant throughput from the 70%-owned Cerro Los Gatos mine during the fourth quarter of 2021 . Silver production in Q4 was 2.3 million ounces and increased 35% compared to the Q3, due primarily to higher mined silver ore grades as well as higher throughput and recoveries. Lead and zinc production in Q4 were slightly below Q3 levels, due to lower mined lead and zinc ore grades. CLG's 2021 silver production of 7.6M ounces exceeded the Company's guidance of 7.4 million ounces. Zinc and lead production of 50 million and 40M pounds, respectively, were both consistent with the Company's 2021 guidance range. CLG achieved record throughput in Q4 totaling 241,397 tonnes, exceeding Q3 throughput by 3.1%. For 2021, 909,586 tonnes were processed, a 36% increase compared to 2020, which included a 45-day pandemic-related temporary suspension of plant operations. CLG achieved record silver recovery during Q4, with recoveries for silver, lead and zinc continuing to exceed design rates. Due to record 2021 production, and elimination of debt service requirements by the early retirement of the Los Gatos Joint Venture Working Capital Facility and Term Loan during 2021, the LGJV had over $20 million of cash at December 31.
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BMY IPSC | Hot Stocks07:07 EST Bristol-Myers, Century Therapeutics announce license agreement - Century Therapeutics (IPSC) and Bristol Myers Squibb (BMY) announced a research collaboration and license agreement to develop and commercialize up to four induced pluripotent stem cell derived, engineered natural killer cell and / or T cell programs for hematologic malignancies and solid tumors. The first two programs include a program in acute myeloid leukemia and a program in multiple myeloma, which could incorporate either the iNK or a gamma delta iT platform. Bristol Myers Squibb has the option to add two additional programs which can be nominated subject to certain conditions agreed with Century in the agreement. Century will be responsible for development candidate discovery and preclinical development activities. Thereafter, Bristol Myers Squibb will be responsible for clinical development and commercialization activities subject to Century's co-promotion rights on certain programs. Under the terms of the agreement, Century will receive a $100M upfront payment and Bristol Myers Squibb will make a $50M equity investment in Century Therapeutics' common stock at a price of $23.14 per share. In addition, Century will receive reimbursement of certain preclinical development costs for development candidates licensed by Bristol Myers Squibb, and is eligible for additional payments for future program initiations and development, regulatory, and commercial milestone payments totaling more than $3B across the four potential programs. Century will also receive tiered royalties as a percentage of global net sales in the high-single to low-double digits. In addition, under the agreement, Century may elect to co-promote the AML program and one of the additional programs in the United States for no exercise fee which will also trigger enhanced U.S. royalties. As part of this transaction, Century has amended its agreements with FUJIFILM Cellular Dynamics for Japanese development and commercialization rights for the products under the Bristol Myers Squibb collaboration.
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EPD | Hot Stocks07:06 EST Enterprise Products to acquire Navitas Midstream Partners for $3.25B - Enterprise Products announced that its affiliate has entered into a definitive agreement to acquire Navitas Midstream Partners from an affiliate of Warburg Pincus in a debt-free transaction for $3.25B in cash consideration. Navitas Midstream provides natural gas gathering, treating and processing services in the core of the Midland Basin of the Permian. Navitas Midstream's assets include approximately 1,750 miles of pipelines and over 1B cubic feet per day of cryogenic natural gas processing capacity with the completion of the Leiker plant, which is expected in the first quarter of 2022. This acquisition provides Enterprise's natural gas processing and NGL business with an entry point into the Midland Basin, one of the most economic and prolific crude oil regions in the United States. Drilling activity in the Midland Basin currently represents approximately 20% of active onshore drilling rigs in the U.S. The system is anchored by long-term contracts and acreage dedications with a diverse group of over forty independent and publicly owned producers. Navitas Midstream provides visibility to future growth with up to 10,000 drilling locations, or over fifteen years of drilling inventory based on current rig counts, on the dedicated acreage. The system is supported by fee-based contracts that provide additional revenues based on commodity prices. This transaction is expected to be completed in the first quarter of 2022 subject to customary regulatory approvals. The transaction is expected to be funded using cash on hand and borrowings under the partnership's existing commercial paper and bank credit facilities. "The system, including its large footprint of low pressure natural gas gathering, is an attractive processing franchise that provides value added services to producers," stated Randy Fowler, co-chief executive officer and chief financial officer of Enterprise's general partner. "We believe this acquisition will be immediately accretive to distributable cash flow per unit. Based on the current outlook for commodity prices in 2023, which would be our first full year of ownership, we believe distributable cash flow accretion will be in the range of $0.18 to $0.22 per unit. This investment will provide Enterprise with an attractive return on capital and support additional capital returns to our limited partners through distribution growth and buybacks of common units."
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EPD | Hot Stocks07:05 EST Navitas Midstream announces sale to Enterprise Products Partners L.P. - Navitas Midstream Partners Holdings announced the sale of 100% of its interests in Navitas Midstream Partners, LLC to an affiliate of Enterprise Products Partners L.P. for $3.25B in an all-cash deal. Navitas is a portfolio company of funds managed by Warburg Pincus LLC, a leading global growth investor. This transaction is expected to be completed in the first quarter of 2022, subject to customary regulatory approvals.
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ORGN | Hot Stocks07:05 EST Origin, Mitsui team to industrialize advanced carbon-negative materials - Origin Materials and Mitsui & Co announced a strategic partnership to industrialize advanced carbon negative materials. This strategic partnership aims to rapidly develop and industrialize new sustainable carbon-negative products for the automotive, chemicals, electronics, packaging, textiles, construction, and personal care industries based on Origin Materials' patented technology platform. The partnership will leverage Mitsui's global supply chain strength, access to Japanese and international markets, and leadership in business innovation. As part of the partnership, Mitsui signed a multi-year capacity reservation agreement to purchase sustainable carbon-negative materials from Origin Materials. "We are pleased to partner with Mitsui, a global leader in multiple business areas, including chemicals, textiles, and many others. We are strategically aligned and share a common vision for the role that sustainable, cost-competitive, carbon-negative materials can play in creating value worldwide," said Rich Riley, Co-CEO of Origin Materials. "This partnership reflects our shared commitment to driving sustainable growth, while reducing greenhouse gas emissions. Additionally, the partnership represents further progress in Origin's mission to enable the world's transition to sustainable materials."
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MDT | Hot Stocks07:02 EST Medtronic to acquire Affera, terms not disclosed - Medtronic announced that it has entered into a definitive agreement to acquire Affera, a Boston area-based, privately held medical technology company. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of patients with cardiac arrhythmias such as atrial fibrillation. Medtronic, through its minority investment portfolio, has been a strategic investor in Affera and currently holds a 3% ownership stake in the company. The acquisition is expected to close the first half of Medtronic fiscal year 2023, subject to the satisfaction to certain customary closing conditions. Following close, the transaction is expected to be less than 1% dilutive to Medtronic's adjusted earnings per share in each of the first three years, and neutral to accretive thereafter. The company expects dilution of approximately 5c in both year 1 and year 2 and approximately 3c in year 3.
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CMC | Hot Stocks06:59 EST Commercial Metals announces plan to construct micro mill - Commercial Metals announced a plan to construct another micro mill geographically situated to primarily serve the Northeast, Mid-Atlantic, and Mid-Western United States markets. CMC believes that the location and capabilities of the planned facility will significantly augment CMC's scale in the Eastern U.S. and synergistically complement its existing operational footprint. CMC is currently in the site selection process and exploring several suitable options. The new micro mill will be among the most environmentally friendly steelmaking operations in the world. The technology to be employed is lower in both energy consumption and greenhouse gas emissions compared to traditional steelmaking processes. Following receipt of state and local incentives, permitting, and other necessary approvals, the construction of the planned mill is expected to take roughly two years.
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CAH | Hot Stocks06:57 EST Cardinal Health provides medical segment update - Cardinal Health provided a FY22 financial update for the medical segment. The company now expects additional inflationary impacts and lower volumes resulting primarily from global supply chain constraints, and a lower-than-expected offset from pricing actions. The company estimates this incremental impact will be approximately $150M to $175M to fiscal year 2022 medical segment profit and approximately 40c to 45c per share to non-GAAP diluted EPS. Excluding this impact to the medical segment and non-GAAP diluted EPS, the company's other financial expectations for FY22 remain unchanged.
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DNAY PFE | Hot Stocks06:55 EST Codex DNA signs collaboration and licensing agreement with Pfizer - Codex DNA (DNAY) announced a strategic collaboration and licensing agreement with Pfizer (PFE) to access and further develop Codex DNA's novel EDS technology for potential application by Pfizer for its mRNA-based vaccines and other biopharma products. The financial terms of the deal include an upfront payment from Pfizer to Codex DNA, along with success-based technical milestone payments that could be earned in the near term. Codex DNA is also eligible to receive additional milestone payments based on the achievement of specified development, regulatory, and commercialization goals associated with any products developed from the application of Codex DNA's technology developed and licensed under the agreement. Pfizer's successful development and commercialization of licensed products could result in milestone payments in excess of $100M.
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OCGN | Hot Stocks06:55 EST Ocugen announces 'positive' phase 2 results in COVID vaccine candidate Covaxin - In a Saturday press release, Ocugen announced "posted positive results from a Phase 2 analysis of the vaccine candidate, COVAXIN, or BBV152, in participants ages 12-64, receiving a booster dose six months following a second dose on the pre-print server, medRxiv. The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy. Additional data from the analysis found that more than 75% of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN. After receiving the booster, participants also saw an increase in antibody titers that were higher than those achieved after the two-dose primary series. Wild-type neutralizing antibodies GMTs at one month after a booster dose against Alpha, Beta, Delta and Delta plus variants were increased 109, 1610, 2647, and 1742 fold from baseline at six months post second dose, respectively. The booster dose analysis also found no serious adverse events, including hospitalization or death, were reported." Shares of Ocugen are up 8.9% at $4.42 in early pre-market trading.
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GCO | Hot Stocks06:54 EST Genesco reports Q4 QTD sales up 18% - Reports Q4 QTD sales up 9% vs FY20. Mimi Vaughn, Genesco board chair, president and chief executive officer, said, "We are pleased with our performance this holiday selling season, especially given the supply chain challenges, as strong full-priced selling drove better than expected sales and profitability. While traffic levels have remained healthy thus far in January, our sales trend has moderated as inventory is currently very lean; however, we expect our in-stock positions to improve as the month progresses and feel confident that we will finish the year strong. Therefore, we are reaffirming our total year EPS guidance of $6.40 to $6.90, with our expectation now above the midpoint of the range."
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CMC | Hot Stocks06:50 EST Commercial Metals expects 'strong' FY22 performances - Smith said, "We continue to anticipate strong fiscal year 2022 financial and operational performances. Volumes should remain solid, supported by a growing construction backlog in North America, as well as broad strength across key end markets in both North America and Europe. The fiscal second quarter has historically seen fewer shipping days due to major holidays and winter weather factors. We expect shipments during the second quarter of fiscal 2022 to follow these typical seasonal trends. Despite additional holidays, we anticipate strong financial results, with margins consistent with, or slightly above, recent levels."
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BHP | Hot Stocks06:50 EST BHP Group to invest $40M in Kabanga Nickel, $10M in Lifezone - Kabanga Nickel announces that BHP has invested $40M in Kabanga Nickel. The money will be used to accelerate the construction of the Kabanga Nickel Project in Tanzania. In parallel, BHP has invested $10M in Lifezone Limited to promote the distribution of its patented technology in hydrometallurgy. The transaction is a total of $50M, including investments in Kabanga Nickel and Lifezone. BHP will invest $90M in unsecured convertible securities within Kabanga Nickel in two phases: An initial investment of $40M, followed by another investment of $50M after the agreement was reached and the terms of the agreement were fulfilled. After completing all legal formalities in Tanzania, the first Phase of $40M will be converted to 8.9% of Kabanga Nickel shares. After being invested and converted into shares, the second installment of $50M will increase BHP shares in the KNL to 17.8%, bringing the project value to $658M. Upon completion of other terms, BHP will be entitled to make further investments in Kabanga Nickel after reaching the agreed criteria. Investment from BHP at Kabanga Nickel will help speed up the construction of the mine. Other activities that will be given priority are relocation of people from the mine area, preliminary preparations for the construction of the mine including the construction of mine roads, staff housing area, construction of water wells and electrical infrastructure. Investment in the Lifezone company allows for new patent applications, in addition to the existing 100 copyright holders, as well as the Research and Development work that will further assist in promoting the hydromet technology market from Lifezone. The current project construction schedule expects production to begin in 2025. Production will increase to a production target of 40,000 tons of nickel, 6,000 tons of copper and 3,000 tons of cobalt per year.
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LULU | Hot Stocks06:48 EST Lululemon falls over 6% after updating Q4 guidance to lower end of prior ranges
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MRK | Hot Stocks06:48 EST Merck's Keytruda shows significant improvement in IB-IIIA NSCLC in phase 3 data - The company states: "Merck announced that the Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 - PEARLS, investigating KEYTRUDA, Merck's anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival for the adjuvant treatment of patients with stage IB-IIIA non-small cell lung cancer, or NSCLC, following surgical resection regardless of PD-L1 expression. Based on an interim analysis review conducted by an independent Data Monitoring Committee, adjuvant treatment with KEYTRUDA resulted in a statistically significant and clinically meaningful improvement in DFS compared with placebo in the all-comer population of patients with stage IB-IIIA NSCLC. At the interim analysis, there was also an improvement in DFS for patients whose tumors express PD-L1 treated with KEYTRUDA compared to placebo; however, this dual primary endpoint did not meet statistical significance per the pre-specified statistical plan. The trial will continue to analyze DFS in patients whose tumors express high levels of PD-L1 and evaluate overall survival, a key secondary endpoint. The safety profile of KEYTRUDA in this study was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities."
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CGEM | Hot Stocks06:45 EST Cullinan enters collaboration agreement with Mount Sinai - Cullinan Oncology announced the company has entered into a collaboration agreement with the Icahn School of Medicine at Mount Sinai to develop novel small molecule immune modulators. This exclusive option and multi-year collaboration agreement will be focused on the optimization and development of oral protein degraders targeting hematopoietic progenitor kinase 1, a key regulator of immune cell activation and a high-priority target in immune-oncology. The collaboration aims to accelerate the development of novel, best-in-class HPK1 degraders that stimulate robust anti-tumor immunity. The research will be conducted by leading scientists at both Cullinan and Icahn Mount Sinai. Cullinan will fund the collaboration and has an exclusive option to license the intellectual property for further development and commercialization.
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AL... | Hot Stocks06:44 EST Air Lease announces Q4 activity update - Air Lease (AL) announced an update on aircraft investments, sales, and new significant financing occurring in the fourth quarter of 2021. As of December 31, 2021, ALC's fleet was comprised of 382 owned aircraft and 92 managed aircraft, with 416 new aircraft on order from Boeing (BA) and Airbus (EADSY) set to deliver through 2028. Delivered fifteen new aircraft from ALC's order book including seven Airbus A321neos, three Airbus A350-1000s, one Boeing 737-8, and four Boeing 737-9s. Aircraft investments in the quarter totaled approximately $1.2B, with the majority occurring in the second half of the quarter. Sold three aircraft to third-party buyers. Issued $300M of 4.125% fixed-rate reset non-cumulative perpetual series C preferred stock. Upsized senior unsecured revolving credit facility to $6.8B from $6.5B.
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LEV | Hot Stocks06:39 EST Lion Electric obtains possession of production facility in Illinois - Lion Electric announced that it has taken possession of its upcoming production facility in Joliet, Illinois. Tenant improvement work is ongoing and the company will shortly begin the installation of critical equipment and expects the first vehicles to come off the production line in the second half of 2022. The manufacturing facility, which was announced last year, will represent the largest dedicated production site for zero-emission medium and heavy-duty vehicles in the U.S. upon its completion, with an expected annual production capacity of up to 20,000 vehicles per year. The facility is expected to add up to 1,400 clean energy jobs in the region over the next four years.
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TLYS | Hot Stocks06:36 EST Tilly's reports holiday period net sales $173.3M, SSS up 14.1% - Tilly's announced net sales results for the nine-week period ended January 1, 2022 in advance of its virtual participation in the ICR Conference 2022 on January 10-12, 2022. Total net sales of $173.3M increased by 16.5% for the 2021 holiday period compared to $148.7M for last year's comparable nine-week holiday period ended January 2, 2021. Total comparable net sales, including both physical stores and e-commerce, increased by 14.1% for the 2021 holiday period compared to an increase of 2.7% for the 2020 holiday period. Comparable net sales in physical stores increased by 23.2% for the 2021 holiday period compared to a decrease of 12.4% during the 2020 holiday period. Comparable net sales in physical stores increased by a double-digit percentage in all but one of 14 geographic markets compared to the 2020 holiday period. Net sales in physical stores represented 74.5% of total net sales for the 2021 holiday period compared to 68.4% of total net sales during the 2020 holiday period. E-commerce net sales decreased by 5.7% for the 2021 holiday period compared to an increase of 65.2% during the 2020 holiday period. E-commerce net sales represented 25.5% of total net sales for the 2021 holiday period compared to 31.6% of total net sales during the 2020 holiday period. Compared to the 2019 holiday period, e-commerce net sales increased by 57.4%. The company believes these results were driven by favorable market conditions, a compelling merchandise assortment, and a shift in our customers' preference for shopping in physical stores over e-commerce compared to last year's holiday period. Last year, the impacts of the COVID-19 pandemic, including government-mandated restrictions on customer traffic in physical stores and reductions in store operating hours in effect during the 2020 holiday period, resulted in increased online shopping relative to physical stores compared to previous years. "Based on our strong 2021 holiday period results, we expect to report our most profitable fourth quarter since becoming a public company and our most profitable full fiscal year on record," commented Ed Thomas, President and CEO.
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MRNA | Hot Stocks06:32 EST Moderna, Carisma enter collaboration agreement for CAR-M therapeutics - Moderna and Carisma Therapeutics announced that the two companies have entered into a strategic collaboration agreement to discover, develop and commercialize in vivo engineered chimeric antigen receptor monocyte, or CAR-M, therapeutics for the treatment of cancer.
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PFE | Hot Stocks06:31 EST Pfizer partners with Acuitas Therapeutics on LNP delivery systems - Pfizer and Acuitas Therapeutics, a company focused on developing lipid nanoparticle delivery systems to enable messenger RNA-based therapeutics, announced they have entered into a Development and Option agreement under which Pfizer will have the option to license, on a non-exclusive basis, Acuitas' LNP technology for up to 10 targets for vaccine or therapeutic development.
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OMI APR | Hot Stocks06:23 EST Owens & Minor to Acquire Apria for $37.50 in cash per share, or $1.45B - Owens & Minor (OMI) and Apria (APR) announced that the companies have entered into a definitive agreement pursuant to which Owens & Minor will acquire Apria for $37.50 in cash per share of common stock, representing an equity value of approximately $1.45B. Under the terms of the agreement, which was unanimously approved by the Board of Directors of each company, Owens & Minor will acquire Apria for $37.50 in cash per share of common stock, representing an equity value of approximately $1.45B, as well as the assumption of debt and cash for a total transaction value of approximately $1.6B. This price per share represents a 26% and 24% premium over Apria's closing share price on January 7, 2022 and 30-day volume weighted average price, respectively. The transaction is subject to customary closing conditions, including the Hart Scott Rodino Act and other regulatory approvals and the approval of Apria's stockholders, and is expected to close during the first half of 2022.
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ALXO | Hot Stocks06:16 EST ALX Oncology announces anticipated milestones in 2022 - Anticipated milestones in 2022 include: Initiation of a randomized Phase 2/3 clinical trial of evorpacept in combination with Herceptin, Cyramza and paclitaxel in patients with 2nd line or greater gastric/GEJ cancer. Dose optimization readout of a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS. Add to and report on investigator sponsored clinical trials with evorpacept. Report on ongoing collaboration with Zymeworks in HER2-expressing breast cancer and other solid tumors. Select development candidate(s) from preclinical pipeline. ALX Oncology ended the third quarter of 2021 with approximately $385.1M in cash and cash equivalents. The company expects that its cash and cash equivalents will be sufficient to fund its planned operations through mid-2024.
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RVPH | Hot Stocks06:10 EST Reviva Pharmaceuticals: FDA clears Phase 3 trial of brilaroxazine - Reviva Pharmaceuticals announced the U.S. FDA has notified the company that it may proceed with Phase 3 clinical investigation of its lead candidate, brilaroxazine, a novel serotonin and dopamine receptor modulator for the treatment of schizophrenia. "We believe that FDA clearance to proceed with initiation of a pivotal Phase 3 trial, as well as an additional Phase 3 trial focused on long-term safety, represents a transformative milestone that may support the filing and approval of a new drug application for our lead candidate brilaroxazine in patients with schizophrenia. Both Phase 3 trials will be initiated simultaneously, with the long-term safety study designed to supplement efficacy and safety data from the pivotal trial," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. "Collectively these two trials may provide a robust Phase 3 assessment of brilaroxazine in patients with schizophrenia that we believe will complement our successful Phase 2 study. We remain highly encouraged by the therapeutic potential of brilaroxazine and look forward to initiating both Phase 3 trials by the end of January 2022."
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TBPH | Hot Stocks06:10 EST Theravance Biopharma enrolls first patient in Yupelri inhalation solution study - Theravance Biopharma announced enrollment of the first patient in a Phase 4 study of Yupelri inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease, or COPD. Success in this study is intended to capture more of Yupelri's addressable market and further strengthen its competitive advantage.
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BYND YUM | Hot Stocks06:08 EST Beyond Meat, Pizza Hut launch plant-based Beyond Italian Sausage Crumbles - Pizza Hut and Beyond Meat announced the launch of plant-based Beyond Italian Sausage Crumbles as a permanent offering at Pizza Hut Canada locations nationwide. Available on three irresistible Beyond Meat dishes, Beyond Italian Sausage Crumbles are designed to deliver the meaty texture and mouthwatering savory taste that fans love about Pizza Hut's traditional Italian pork sausage. These new menu items are exclusive to Pizza Hut and are back by popular demand after a successful trial in Toronto and Edmonton last summer. This national launch in Canada is part of a larger global strategic partnership between Yum! Brands (YUM), the parent company to Pizza Hut, and Beyond Meat (BYND) to create delicious and innovative plant-based protein menu items that meet the growing consumer demand for more diverse protein options.
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RCM | Hot Stocks06:05 EST R1 RCM to acquire Cloudmed for $4.1B - R1 RCM announced that it has entered into a definitive agreement to acquire Cloudmed, a leader in Revenue Intelligence solutions for healthcare providers, in an all-stock transaction. The transaction values Cloudmed at approximately $4.1B, including $857M of net debt, based on R1's closing stock price on January 7, 2022. The transaction is expected to be accretive to R1's earnings per share in the first full year post-closing. R1 expects to unlock cost synergies of $85M by the end of year three and $98M at full run-rate, as well as significant revenue synergies over time. R1 expects to have approximately 2.7x net leverage upon closing of the transaction and anticipates strong cash flow generation post-close. Upon closing of the transaction, current R1 shareholders will own approximately 70% of the combined company on a fully diluted basis and Cloudmed equity holders will own approximately 30%. Cloudmed equity holders will enter into an 18-month lockup agreement, subject to partial early release after six months under certain circumstances. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2022, subject to approval of the stock issuance by R1 shareholders, the effectiveness of a registration statement on Form S-4, receipt of regulatory approvals and the satisfaction of other customary closing conditions. Joe Flanagan, CEO of R1, will serve as CEO of the combined company, and Lee Rivas, CEO of Cloudmed, will serve as president of the combined company. Upon closing of the transaction, R1 will increase the size of its Board of Directors to include three new board members nominated by New Mountain Capital.
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AES | Hot Stocks06:03 EST AES Corp. increases ownership of AES Andes to 98.13% - AES Corp. announced the results of the tender offer by AES' wholly-owned Chilean subsidiary, Inversiones Cachagua SpA, for the shares of AES Andes S.A. held by minority shareholders. Upon completion, which is expected on or about January 12, AES will increase its interest in AES Andes from 66.98% to 98.13%. AES Andes has 4.4 GW in operation throughout Chile, Colombia and Argentina, with an additional 1.1 GW under construction and is working with leading mining companies to decarbonize their portfolios. AES Andes has already announced the retirement or sale of 2.2 GW of coal-fired generation and the addition of 2.4 GW of renewables. As a result of this transaction, AES Andes will have a shareholder structure, which will enable the company to more efficiently execute on its large renewables pipeline to further accelerate its transformation. The tender offer was launched on December 7, 2021, and minority shareholders tendered 3,232,850,689 shares of AES Andes, equivalent to 94.35% of the offer. All conditions of the offer have been met and these shares will be purchased at the tender price of CLP 135.14 per share. The aggregate consideration for the shares acquired is $517M, to be funded through a combination of at least $350M of non-recourse debt and the remainder from available corporate liquidity. Over the medium term, AES may seek to take AES Andes private if the conditions for delisting the company are met.
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PFE BEAM | Hot Stocks06:03 EST Pfizer, Beam Therapeutics announce four-year research collaboration - Pfizer (PFE) and Beam Therapeutics (BEAM) announced an exclusive four-year research collaboration focused on in vivo base editing programs for three targets for rare genetic diseases of the liver, muscle and central nervous system. The base editing programs to be evaluated as part of the collaboration will leverage Beam's proprietary in vivo delivery technologies, which use messenger RNA and lipid nanoparticles to deliver base editors to target organs. Combining these technologies with Pfizer's proven experience in developing and manufacturing medicines and vaccines, this collaboration seeks to advance potentially transformative therapies for patients living with rare diseases. Under the terms of the collaboration agreement, Beam will conduct all research activities through development candidate selection for three undisclosed targets, which are not included in Beam's existing programs. Pfizer may opt in to exclusive, worldwide licenses to each development candidate, after which it will be responsible for all development activities, as well as potential regulatory approvals and commercialization, for each such candidate. Beam has a right to opt in, at the end of Phase 1/2 studies, upon the payment of an option exercise fee, to a global co-development and co-commercialization agreement with respect to one program licensed under the collaboration pursuant to which Pfizer and Beam would share net profits as well as development and commercialization costs in a 65%/35% ratio (Pfizer/Beam). Beam will receive an upfront payment of $300M and, assuming Pfizer exercises its opt-in license rights for all three targets, is eligible for development, regulatory and commercial milestone payments for potential total deal consideration of up to $1.35B. Beam is also eligible to receive royalties on global net sales for each licensed program. The collaboration has an initial term of four years and may be extended up to one additional year.
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OMI APR | Hot Stocks06:00 EST Owens & Minor to Acquire Apria for $37.50 in cash per share, or $1.45B
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HGEN | Hot Stocks05:59 EST Humanigen outlines next steps for lenzilumab - Humanigen outlined the next steps for the development of its lead candidate, lenzilumab, in the prevention of CAR-T therapy related toxicities including ICANS and CRS in patients with relapsed or refractory Non-Hodgkin lymphoma, or rrNHL. FDA Type C meeting and advice creates alignment on registration pathway for Phase 3 clinical development of lenzilumab for the prevention of CAR-T therapy related toxicities including Immune Effector Cell-Associated Neurotoxicity and Cytokine Release Syndrome, or CRS. Randomized, double-blind, placebo-controlled SHIELD trial to commence in H1 2022, designed to inform a potential label that reflects both the clinical benefit of lenzilumab and the economic benefit. The SHIELD study will begin recruitment in H1 2022, with preliminary data potentially being shared at the American Society of Hematology congress in December 2022.
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OCFT | Hot Stocks05:39 EST OneConnect enters partnership with Chengfang Financial - OneConnect announced it has entered into a strategic partnership with Chengfang Financial. Both parties will work together to address common pain points in the financial industry, deliver technological innovations, and enhance data processing and governance. Under the agreement, OneConnect and Chengfang Financial Technology will harness technologies -- including AI, cloud computing and big data -- to explore new applications for data privacy technology in bank surveillance systems, promote the introduction and sharing of new data standards, and identify the financial data collaboration and circulation models needed by businesses to meet the requirements for secure cloud computing. In addition, the two parties will carry out research and development in areas such as secure computing technology, blockchain, and graph data; as well as nurture and cultivate new FinTech talents for the future.
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AMGN | Hot Stocks05:37 EST Amgen receives EC marketing authorization for Lumykras - Amgen announced that the European Commission, or EC, has granted conditional marketing authorization for Lumykras, a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell lung cancer with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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BHVN | Hot Stocks05:35 EST Biohaven Pharmaceutical subsidiary enters license agreement with KU Leuven - Biohaven Therapeutics, a subsidiary of Biohaven Pharmaceutical, along with CD3 and LICR at KU Leuven, announced that they have entered into a global license and research agreement to develop and commercialize first-in-class TRPM3 antagonists to address the growing proportion of people worldwide living with chronic pain disorders. The TRPM3 antagonist platform was discovered at the Centre for Drug Design and Discovery and the Laboratory of Ion Channel Research at KU Leuven. BHV-2100 is the lead TRPM3 antagonist from the platform and an orally-bioavailable small molecule TRPM3 antagonist. TRPM3 is a cation channel involved in pain signaling and a novel target for the treatment of pain discovered at KU Leuven's LICR. Consistent with the role of TRPM3 in pain, data generated at KU Leuven demonstrated that BHV-2100 may reduce pain behaviors in animal models without the detrimental side-effects seen with other pain management approaches and mechanisms.
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MOLN NVS | Hot Stocks05:32 EST Molecular Partners, Novartis report Part A of EMPATHY trial met primary endpoint - Molecular Partners (MOLN) and Novartis (NVS) announced that Part A of the EMPATHY clinical trial, that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo to treat COVID-19, met the primary endpoint of viral load reduction over eight days. The two secondary endpoints also showed clinically meaningful benefit over placebo composite endpoint of hospitalization and/or Emergency Room, or ER, visits or death, and time to sustained clinical recovery. Novartis confirms it will now exercise its option to in-license ensovibep from Molecular Partners and, following exercise of the option, will seek expedited access globally, first via the FDA's EUA process. The global EMPATHY clinical trial, which is being conducted by Novartis, with Molecular Partners as sponsor, is a randomized, double-blind, placebo controlled study in ambulatory adult patients with COVID-19. EMPATHY Part A enrolled 407 patients to identify a dose of ensovibep with optimal safety and efficacy and recruited patients in the USA, South Africa, India, the Netherlands, and Hungary to explore three doses: 75mg, 225mg and 600mg. Results from the study showed that the primary endpoint was met with a statistically significant reduction in viral load over eight days, compared to placebo, for all three dosing arms. The secondary endpoint of hospitalization and/or ER visits related to COVID-19, or death showed an overall 78% reduction in risk of events across ensovibep arms compared to placebo. Treatment arms were generally balanced in terms of demographic, baseline and disease characteristics. The placebo arm with 99 patients had a total of six events; five patients were hospitalized, two of whom died due to worsening of COVID-19 and one patient had an ER visit only. In the 301 patients treated with ensovibep, there were four events; hospitalizations occurred in two patients and two needed to visit ER. No deaths occurred in any of the patients treated with ensovibep. All doses were well-tolerated and no unexpected safety issues were identified for any of the doses2. The lowest dose of 75mg is the planned dose for further development. The data will now undergo further review so that Novartis and Molecular Partners can determine the appropriate next steps for the program.
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WTI | Hot Stocks05:23 EST W&T Offshore to acquire oil, gas producing properties in GOM for $47M - W&T Offshore announced that it has entered into a definitive purchase and sale agreement to acquire working interests in and operatorship of oil and gas producing properties in federal shallow waters in the central region of the Gulf of Mexico, or GOM, for total cash consideration of $47M, subject to normal and customary post-effective date adjustments. The transaction will have an effective date of July 1, 2021, and is anticipated to close by the end of the first quarter of 2022. W&T is acquiring operated, producing shallow water assets in the central region of the GOM at Ship Shoal 230, South Marsh Island 27/Vermilion 191, and South Marsh Island 73 fields from privately-held Akor E&P Holdings and KOA Energy for cash consideration of $47M and assumption of related asset retirement obligations, subject to normal and customary post-effective date adjustments. The acquisition includes 53 producing wells and 16 structures. The effective date of the transaction is July 1, 2021 and is anticipated to close by the end of the first quarter of 2022. The acquisition will be funded entirely using cash on hand. Production volumes, sales, and costs associated with the acquired properties will be included in W&T's results following the closing of the transaction. Current estimated production from the properties is 2.5 MBbl per day of oil and 5.4 MMcf per day of natural gas, or a total of 3.4 MBoe per day. The company estimates proved reserves as of July 1, 2021 were 5.5 MMBoe, of which 69% is oil. Substantially all of the proved reserves are proved developed. Using the same assumptions described above, estimated proved and probable, or 2P, reserves were 7.6 MMBoe. Since the transaction is expected to close in early 2022, net reserves added from the transaction will be included in W&T's mid-year 2022 reserve report. The transaction will increase W&T's Federal shallow water acreage by approximately 57,500 gross acres.
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PSTI | Hot Stocks05:18 EST Pluristem, Tnuva Group to establish cultured food platform - Pluristem (PSTI) and Tnuva Group announced the launch of a collaboration to develop, manufacture and commercialize cultured cell-based products for the food industry. The collaboration started with the incorporation of a new company, or NewCo, that will receive exclusive, global, royalty bearing licensing rights to use Pluristem's proprietary technology, intellectual property and knowhow, to be used in the field of cultured meat. Tnuva Group will invest $7.5M in NewCo, according to a pre-money valuation of $40M, with the option to invest up to an additional $7.5M over a period of 12 months following the closing. NewCo will use its own funding and resources to promote its mission with a dedicated management team and staff, and Pluristem will support the establishment, research and development activities of NewCo pursuant to a services agreement. Tnuva will provide the R&D platform to develop consumer products and will receive preferred marketing rights of any developed NewCo's products in Israel. Pluristem has the industry-leading capacity to design, develop, and manufacture cells for commercial use. Over the last two decades, the company developed a proprietary three-dimensional expansion platform that can produce high-quality cells in a cost-effective manner with batch-to-batch consistency. According to both parties' estimates and plans, NewCo intends to present its technology Proof of Concept in 2022, with the goal of launching its first raw cultured meat product in 2023. As part of the collaboration, the Parties may expand the collaboration to include cultured dairy and cultured fish products by establishing separate, new ventures.
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ESLT | Hot Stocks05:15 EST Elbit Systems UK sells power and control business of Ferranti for $12M in cash - Elbit Systems and announced that its UK subsidiary, Elbit Systems UK, has sold the power and control business of its subsidiary Ferranti Technologies to TT Electronics for approximately $12M in cash, subject to customary post-completion working capital adjustments. The remaining business of Ferranti, including training and simulation, avionics, display systems, aircrew survival systems, platform protection and computing, are planned to be integrated into Elbit Systems UK.
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IDCC SONY | Hot Stocks05:12 EST InterDigital, Sony Corporation of America extend pact and renew patent license - InterDigital (IDCC) announced an extension of its business partnership and renewal of its patent license with Sony Corporation of America (SONY). As well as renewing Sony's license to InterDigital's patent portfolio, the companies agreed to extend the term of the Convida Wireless joint venture, which has helped them deepen their research in areas such as 5G and the Internet of Things.
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