Stockwinners Market Radar for December 13, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
SOFI | Hot Stocks20:32 EST SoFi Technologies CEO buys $5M in common stock - In a regulatory filing, SoFi Technologies disclosed that its CEO Anthony Noto bought 1.1M shares of common stock on December 9th in a total transaction size of $5.0M.
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VERV | Hot Stocks20:07 EST Cathie Wood's ARK Investment bought 49K shares of Verve Therapeutics today
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AVA | Hot Stocks19:35 EST Avista receives commission approval of settlement in Washington rate cases - Avista's electric and natural gas general rate cases have concluded, with an order from the Washington Utilities and Transportation Commission that approved the multi-party settlement filed in June 2022. The Commission approved increases of annual electric revenues of $38 million effective Dec. 21, 2022 and $12.5 million effective Dec. 21, 2023 and increases in annual natural gas revenues of $7.5 million effective Dec. 21, 2022 and $1.5 million effective Dec. 21, 2023. To reduce the overall impact of these increases on customers, the Commission approved the use of a Residual Tax Customer Credit that will be returned to customers over a two-year period. The credit will provide benefits of $27.6 million for electric customers and $12.5 million for natural gas customers.
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ASTS | Hot Stocks19:33 EST AST SpaceMobile says on track to deliver first space-based broadband - AST SpaceMobile provides an operational update on the BlueWalker 3, Block 1 BlueBird and next-generation BlueBird programs. CEO Abel Avellan stated: "The achievements to date for BlueWalker 3 validate the design roadmap for our BlueBirds, including deploying and flying the largest-ever commercial communications array in low Earth orbit, a key fundamental and patented technology to deliver space-based cellular broadband directly to unmodified phones. On the back of the successful deployment of BW3's communications array, we look forward to initiating testing with our mobile network operator partners starting early in the first quarter of 2023."
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COHU | Hot Stocks19:04 EST Cohu announces collaboration with CHPT on semiconductor test products - Cohu "announced a strategic collaboration with Chunghwa Precision Test Tech. Co., Ltd., a leading provider of test interface solutions, to deliver advanced probe card and interface products to the semiconductor test market. The trend in 5G mobility and Automotive ADAS sensors toward high-frequency and smaller devices creates significant test challenges, leading to increased instrumentation and interface complexity. The combination of Cohu's mmWave RF probe head and socket technology with CHPT's advanced substrate and load boards will create an optimized turnkey interface solution for probe and final test, lowering customers' costs and improving time to market. Additionally, the combined engineering and manufacturing resources of both companies will enable scale manufacturing of multisite interface products with test speed performance greater than 60 GHz. The companies intend to collaborate on expanding high-performance interface solutions for final test, and semiconductor probe cards for wafer test, delivering complete solutions to customers in Taiwan and around the globe. Cohu also intends to further commercialize CHPT's MEMS probe technology, accelerating growth in the semiconductor probe card market that is projected to grow to an estimated $3.6 billion by 2027. "
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VLNS | Hot Stocks18:32 EST Valens receives 180 days extension from Nasdaq to regain compliance - The Valens Company announced it received an extension of 180 calendar days from the Nasdaq Stock Market to regain compliance with the Nasdaq's minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550 for continued listing on the Nasdaq Capital Market, following the expiration of the initial 180 calendar days period to regain compliance on December 12, 2022. The Nasdaq determination is based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market with the exception of the Bid Price Requirement, and the Company's written notice of its intention to cure the deficiency during the second compliance period by effecting a share consolidation, if necessary. As a result of the extension, the Company now has until June 12, 2023, to regain compliance with the Bid Price Requirement
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CYTK | Hot Stocks18:28 EST Cytokinetics falls 7% to $35.50 after resumption of trading - Shares of Cytokinetics are down 7% afterhours at $35.50 after resumption of trading. Shares had been halted since this morning pending the outcome of FDA AdCom vote on Omecamtiv Mecarbil, and the committee voted 8 to 3 that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction.
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AJG | Hot Stocks18:01 EST Arthur J. Gallagher acquires Aviation Insurance Australia for undisclosed amount - Arthur J. Gallagher & Co. announced the acquisition of Brisbane, Queensland-based Aviation Insurance Australia. Terms of the transaction were not disclosed. Founded in 1993, Aviation Insurance Australia is a specialist retail insurance broker serving aviation and aerospace clients throughout the country. Ian Tait and his team will remain in their current location under the direction of Paul Harvey, Managing Director of Specialisms for Gallagher in Australia.
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CYTK | Hot Stocks17:54 EST Cytokinetics to resume trading at 18:15ET - Quotation on the stock will resume at 18:10ET, according to Nasdaq. Shares had been halted since 06:55ET this morning ahead of the FDA AdCom decision on Omecamtiv Mecarbil.
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CYTK | Hot Stocks17:48 EST Cytokinetics: FDA panel says benefits of omecamtiv mecarbil do not outweigh risk - Cytokinetics announced that the U.S. FDA Cardiovascular and Renal Drugs Advisory Committee voted 8 to 3 that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction. "We are disappointed there was not a greater consensus amongst Committee members relating to the benefit-risk of omecamtiv mecarbil, and we maintain our conviction in the strength of evidence supporting its potential benefit for patients suffering from HFrEF," said Robert I. Blum, Cytokinetics' President and CEO. "We continue to believe omecamtiv mecarbil can be a valuable add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization despite treatment with available guideline-directed medical therapy. We plan to engage constructively with FDA as it completes its review of the application for omecamtiv mecarbil."
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TFPM | Hot Stocks17:32 EST Triple Flag buys gross revenue return on Prieska - Triple Flag Precious Metals "announced today that its wholly owned subsidiaries have entered into definitive agreements for the acquisition of the previously announced A$10 million gross revenue return and $80 million gold and silver stream on the Prieska Copper-Zinc Mine with Orion Minerals Ltd. Closing of the GRR is subject to obtaining exchange control approvals from the South African Reserve Bank and drawdown of the Industrial Development Corporation of South Africa Limited convertible loan and will be drawn down pro rata with the IDC convertible loan. The closing of the Stream is also conditional on obtaining exchange control approvals from the South African Reserve Bank, the mine development being fully funded and Orion finalizing an executable mine plan to Triple Flag's satisfaction."
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AIZ | Hot Stocks17:24 EST Assurant finalizes restructuring plan, sees up to $65M in charges - On December 13 Assurant, finalized its plan to realize greater operational efficiencies by continuing to simplify its business portfolio and leverage its global footprint to reduce costs. This includes realigning its organizational structure and talent to support its business strategy. The Company is also accelerating its ongoing real estate consolidation to support work-from-home arrangements given its increasingly hybrid workforce. The Company expects to complete these actions in 2023.The Company expects to incur total pre-tax restructuring charges of approximately $60M to $65M, with approximately $51M to $56M to be incurred in fourth quarter 2022 and the remainder to be incurred in 2023. The total expected range includes approximately $29M to $34M related to severance and employee benefits, and approximately $31M related to real estate exit costs, consisting of lease impairment and abandonment charges. The Company estimates that substantially all of the charges will be cash. The Company expects approximately $55M in gross annualized run rate savings to be realized from these actions by year-end 2024, with more than half expected to be realized in 2023. These savings will partially mitigate the impact of higher labor costs and headwinds from the macroeconomic environment, as well as fund additional investments, including increasing automation, to continue to drive a more efficient cost structure long term. The Company expects to provide its full year 2023 outlook during its fourth quarter 2022 earnings call in February
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PFE | Hot Stocks17:24 EST Pfizer awarded $1.96B Army contract modification for Paxlovid - Pfizer was awarded a $1.96B modification to a contract for the oral therapeutic Paxlovid. Work will be performed in New York, New York, with an estimated completion date of December 31, 2028. FY21 Coronavirus Preparedness Response and Relief Supplemental Appropriations Act funds in the amount of $1.96B were obligated at the time of the award. U.S. Army Contracting Command is the contracting activity.
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CELC | Hot Stocks17:18 EST Celcuity CEO buys $1.5M in common stock - In a regulatory filing, Celcuity disclosed that its CEO Brian Sullivan bought 261K shares of common stock on December 9 in a total transaction size of $1.5M.
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AVAH | Hot Stocks17:12 EST Aveanna announces retirement of its CEO Tony Strange - Aveanna Healthcare Holdings announced that its CEO and Director, Tony Strange, is retiring and will depart the company effective December 31. Jeff S. Shaner, Aveanna's long serving COO, will serve as CEO and Director, effective December 31.
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AVA | Hot Stocks17:10 EST Avista announces retirement of CEO Tony Strange - Aveanna Healthcare Holdings announced that its CEO and Director, Tony Strange, is retiring and will depart the company effective December 31. Jeff S. Shaner, Aveanna's long serving Chief Operations Officer, will serve as CEO and Director, effective December 31.
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MEOH | Hot Stocks17:02 EST Methanex names Dean Richardson as new CFO - Methanex "announces the following appointments to its executive leadership team by Rich Sumner who, as previously announced, will assume the role of President and CEO as of January 1, 2023: Dean Richardson, currently Vice President, Corporate Finance, has been appointed as Senior Vice President, Finance and Chief Financial Officer, as of February 1, 2023. Mr. Richardson has worked closely with Ian Cameron, retiring Senior Vice President, Finance and Chief Financial Officer for over a decade, in a variety of progessively senior and strategic finance roles. Kevin Maloney, currently Vice President, Corporate Development, has been appointed as Senior Vice President, Corporate Development as of January 1, 2023. Vanessa James will step down from her role as Senior Vice President, Corporate Development and Sustainability and will support the transition through the first half of Q1 2023. Mr. Maloney, in his current role, is the Geismar 3 project business owner and is well equipped to seamlessly take over executive leadership of G3, Methanex's highly advantaged project which is expected to produce methanol in Q4 2023."
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LIAN | Hot Stocks17:01 EST LianBio announces departure of President and Chief Strategy Officer Debra Yu - LianBio announced that Debra Yu, LianBio's, has resigned from the Company, effective January 1, 2023, to pursue other business and professional interests and opportunities. To facilitate her transition, Yu entered into a consulting agreement with LianBio effective January 1, 2023, through June 30, 2023. Yu joined the Company when LianBio was first established in 2019. She has been a valued member of LianBio's executive team and an integral part of LianBio's transformation from an early-stage startup into a late clinical stage biotechnology company.
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SLAC | Hot Stocks17:01 EST Social Leverage Acquisition I transfers listing to Nasdaq - Social Leverage Acquisition Corp I, a special purpose acquisition company, announced that it expects to transfer its listing from The New York Stock Exchange to the Nasdaq Global Market on the Nasdaq Stock Market LLC, where it has been approved for listing subject to confirmation of its satisfaction of the Nasdaq's listing standards. Following the transfer, SLAC intends to continue to file the same types of periodic reports and other information it currently files with the U.S. Securities and Exchange Commission. SLAC anticipates the transfer to the Nasdaq to occur on or about December 27, 2022.
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FWAC | Hot Stocks16:53 EST Fifth Wall Acquisition Corp. III to merge with Mobile Infrastructure Corp. - Fifth Wall Acquisition Corp. III announced that it entered into a definitive business combination agreement with Mobile Infrastructure Corp., one of the largest institutional-quality, mobility-focused parking asset owners in the U.S. Upon the closing of this transaction, the combined company expects to be publicly traded on the New York Stock Exchange under the ticker "BEEP." The business combination values the combined company at a post-money equity valuation of approximately $550M assuming no public shareholders of FWAC exercise their redemption rights. The combined company is expected to have up to approximately $276M in cash at closing, including $275M of cash held in FWAC from its initial public offering on May 27, 2021. The transaction is further supported by a $10M PIPE investment from No Street Capital, an existing MIC shareholder. MIC and FWAC are aligning long-term interests. FWAC's sponsor has agreed to defer a portion of its founder shares in an earn-out with vesting at significant premiums to FWAC's current share price, while MIC's CEO has elected to receive 100% of his 2023 compensation in stock. In addition, a portion of the FWAC Sponsor's founder shares will be cancelled for no consideration. The combined company will have significant insider ownership, and MIC's existing investors are rolling 100% of their equity in the transaction. Additionally, no SPAC warrants have been issued, and as a result, shareholders will benefit from less dilution and a simplified capital structure. The transaction has been unanimously approved by the Boards of Directors of both MIC and FWAC. The transaction is expected to close in the second quarter of 2023, subject to the satisfaction of customary closing conditions, including the approval of shareholders of both parties.
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AMPY | Hot Stocks16:48 EST Amplify Energy: Revolving credit facility extended, borrowing base redetermined - Amplify Energy announced that it completed its regularly scheduled semi-annual borrowing base redetermination and entered into an amendment to extend its credit agreement from November 2, 2023 to May 31, 2024. The redetermination resulted in a revised borrowing base of $215M effective immediately with scheduled monthly reductions of $5M until otherwise redetermined or adjusted in accordance with the provisions of the Credit Agreement. As of November 30 Amplify had total net debt of $167M, with $190M outstanding under its credit facility and $23M of cash on hand.Martyn Willsher, Amplify's President and Chief Executive Officer commented, "We'd like to thank all the lenders in our bank group for their continued support and working collaboratively to extend the credit facility into May of 2024. The extension of our credit facility's maturity provides more time and flexibility to refinance after Beta returns to production, which we anticipate occurring by the end of the first quarter of 2023."
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INDO | Hot Stocks16:48 EST Indonesia Energy announces production updates - Indonesia Energy "announced production updates on its Kruh 27 and Kruh 28 wells. These two back-to-back discovery wells were drilled by IEC during 2022 at its 63,000-acre Kruh Block. Fracture stimulation of the already oil producing Kruh 27 well has been completed, with 80 thousand pounds of proppants having been injected into the sand producing reservoir with the goal of increasing production productivity. A previous fracturing program conducted in IEC's Kruh 26 well brought the original production of 18 barrels of oil per day to a post-fracturing rate of 75 BOPD. IEC anticipates that the stimulation work at Kruh 27 could provide similar production enhancement after the well begins production again expected in January 2023."
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PMTS | Hot Stocks16:47 EST CPI Card Group names Lane Dubin Chief Development and Digital Officer - CPI Card "announced organizational changes designed to expand the Company's long-term growth opportunities, including new product and new business development, and better align the organization to further support end-to-end and innovative solutions for customers in its debit and credit and prepaid businesses. Lane Dubin has been promoted to the newly-created position of Executive Vice President and Chief Development and Digital Officer. In this role, he will be responsible for new product and new business development, including digital payment solutions. Dubin was most recently CPI's Senior Vice President and General Manager Prepaid, Personalization Solutions, and Instant Issuance. John Lowe has been promoted to Executive Vice President, End-to-End Payment Solutions. Lowe was previously Senior Vice President and General Manager Secure Card and now adds Personalization Solutions and Instant Issuance to his organization, which will allow the Company to optimize customer experience and sales efforts for all debit and credit products and services."
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DS | Hot Stocks16:45 EST Drive Shack to voluntarily delist from the NYSE - Drive Shack announced its intention to voluntarily delist from the NYSE and to deregister its common stock under Section 12 and Section 12 of the Securities Exchange Act of 1934, as amended, and suspend its reporting obligations under Section 15 of the Exchange Act. The Company received a notice that its securities are not in compliance with the continued listing standards of the NYSE, and in response has evaluated its options to remain listed or to go dark and has determined that going dark is the best path for the Company due to expected cost savings and the Company's current inability to realize the traditional benefits of public company status. The Company intends to file an application for its common stock to be quoted on the OTCQX platform, operated by OTC Markets Group Inc. and intends to receive approval in the Q1 of 2023. The Company intends to continue to provide information to its stockholders and to take such actions to enable a trading market in its common stock to exist.
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AWK | Hot Stocks16:41 EST CPUC approves American Water's Monterey expansion - The company states: "On December 1, 2022, the California Public Utilities Commission approved the Water Purchase Agreement between Monterey One Water, the Monterey Peninsula Water Management District and California American Water to fund the expansion of the Pure Water Monterey project. While California American Water continues to support the Expansion project, the company will seek a rehearing of the decision on limited issues related to funding of the project and will seek to resolve these issues as quickly as possible. Recognizing that the different components of the water supply project are interrelated, the company reduced the size of the desalination plant in light of the expected additional water supplies from the Pure Water Monterey Expansion."
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RBCN | Hot Stocks16:36 EST Rubicon announces voluntary delisting from Nasdaq - Rubicon Technology, announced that it has notified The Nasdaq Stock Market of the Company's decision to voluntarily delist its common stock from the Nasdaq Capital Market and its intent to file a Form 25 with the U.S. Securities and Exchange Commission on or about December 23, As a result, the Company expects the delisting of its common stock to become effective on December 30.
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GEOS | Hot Stocks16:35 EST Geospace signs $9M shallow water ocean bottom node rental contract - Geospace "announced a rental contract with an international marine geophysical services provider who will rent OBX shallow water ocean bottom wireless seismic data acquisition nodes. Based on current contract terms, the value of the agreement is estimated at $9M."
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BIMI | Hot Stocks16:35 EST BIMI announces reduction of purchase price for the Hospitals to RMB 80K - BIMI International Medical announced its entry into an Amendment to the Stock Purchase Agreement originally entered into as of April 9 for the acquisition of Wuzhou Qiangsheng Hospital. The Amendment provided for the reduction of the purchase price for the Hospitals from RMB 162,000,000 to RMB 80,000,000, including a retroactive decrease in the closing cash payment from RMB 20,000,000 to mil and a retroactive decrease in the closing stock payment from 800,000 shares of the BIMI common stock to 164,000 shares of BIMI common stock. As a result of the amendment, the sellers of the Hospitals agreed to return RMB 20,000.000 in cash and 636.000 shares of the Company's common stock immediately. The sellers agreed that the 2021 and 2022 performance targets as set forth in the April 2021 agreement were not met and therefore, they are not entitled to either of the contingent payments provided for in the original agreement.In light of the forfeited performance payments due to the Hospitals' failure to meet the performance targets for 2021 and 2022, a new 2023 performance target of RMB 5,500,000 in net profit and a corresponding performance payment in the amount of RMB 64,000,000 were added in the Amendment as well as certain post-closing agreements which give the Company the right to sell the Hospitals back to their original owners upon the occurrence of certain events, and the original owners the right to buy the Hospitals back upon occurrence of certain events.All the numbers of shares of the Company's common stock in this press release do not reflect the reverse stock split that be
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VLON | Hot Stocks16:35 EST Vallon Pharmaceuticals Inc trading resumes
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BEN | Hot Stocks16:32 EST Franklin Resources raises quarterly dividend by 3.4% to 30c per share - The dividend is payable on January 13, 2023 to stockholders of record holding shares of common stock at the close of business on December 30, 2022.
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EGLE | Hot Stocks16:32 EST Eagle Bulk CFO Frank De Costanzo to step down, Costa Tsoutsoplides to succeed - Eagle Bulk Shipping announced Frank De Costanzo will step down as CFO and then serve as a special advisor to the board of directors through the end of 2023. Furthermore, the board of directors approved the promotion of Costa Tsoutsoplides to CFO. The transition will be effective April 1, 2023.
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BTRS | Hot Stocks16:31 EST BTRS Holdings stockholders approve proposed merger with EQT - BTRS Holdings "announced that its stockholders voted to approve the definitive merger agreement with an affiliate of EQT X Fund at a special meeting of the Company's stockholders."
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DLR | Hot Stocks16:26 EST Digital Realty names Andy Power as CEO, succeeding A. William Stein - Digital Realty announced that its Board of Directors has appointed current President and CFO, Andrew Power, as its CEO and to the Board of Directors, effective immediately. CEO A. William Stein has departed from his role as CEO and resigned from the Board of Directors. Stein will remain with the company through year end. Prior to joining Digital Realty, Power held positions of increasing responsibility in investment banking, having most recently served as Managing Director at Bank of America Merrill Lynch. Power was also a member of the lead underwriting team that advised Digital Realty on its initial public offering in 2004.
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BRZE | Hot Stocks16:23 EST Braze falls 6% to $27.16 after Q3 results and guidance
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ICVX | Hot Stocks16:23 EST Icosavax reports durability data for VLP vaccine IVX-121 against RSV - Icosavax provided a six-month immunogenicity update from its Phase 1/1b trial of IVX-121 against Respiratory Syncytial Virus (RSV). These new data demonstrate a sustained neutralizing antibody nAb response against RSV, lasting for at least six months after a single administration of IVX-121. "We are delighted to share the six-month immunogenicity data from our Phase 1/1b trial of IVX-121. The potential for long-lasting immune responses was part of our founding hypothesis and preclinical rationale for developing combination VLP vaccines, so it is exciting to see this supportive initial clinical data on durability from our platform," said Adam Simpson, Chief Executive Officer of Icosavax. "We continue to believe that there is a need for better vaccines, in particular the potential for combination respiratory vaccines with longer-lasting protection and low reactogenicity."
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WDFC | Hot Stocks16:21 EST WD-40 raises quarterly dividend by 6% to 83c per share - The quarterly dividend is payable January 31, 2023 to stockholders of record at the close of business on January 13, 2023.
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WDFC | Hot Stocks16:21 EST WD-40 names Gregory A. Sandfort as non-executive board chairman - WD-40 "announced the appointment of Gregory A. Sandfort as non-executive chairman of the board of directors, effective today. Mr. Sandfort replaces Garry O. Ridge as chairman following his retirement from the board after today's 2022 Annual Meeting of Stockholders, and Mr. Sandfort remains a member of the Compensation Committee, Corporate Governance Committee, and Finance Committee."
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MTTR EGHT | Hot Stocks16:21 EST Matterport appoints Matthew Zinn as chief legal officer - Matterport (MTTR) announced two key executive hires to join the company's leadership team effective immediately. Matthew Zinn will join Matterport's executive leadership team as the company's chief legal officer, responsible for overseeing the company's global legal, regulatory, privacy, and compliance efforts, as well as serving as the corporate secretary. Mike Knapp joins as the VP and head of investor relations, responsible for Matterport's investor relations strategy with a focus on proactively communicating the company's vision and growth strategy while continuing to build relationships with the investment community. Zinn most recently served as chief legal officer at 8x8 (EGHT).
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VLON | Hot Stocks16:20 EST Vallon acquires bio-tech company GRI Bio in all-stock deal - Vallon Pharmaceuticals and GRI Bio a privately held biotechnology company advancing an innovative pipeline of Natural Killer T cell regulators for the treatment of inflammatory, fibrotic and autoimmune diseases, announced that they have entered into a definitive agreement pursuant to which GRI Bio will merge with a wholly-owned subsidiary of Vallon in an all-stock transaction. The combined company will focus on advancing GRI Bio's innovative pipeline of NKT cell regulators for the treatment of inflammatory, fibrotic and autoimmune diseases. Following the closing of the Merger, the combined company is expected to operate under the name "GRI Bio " and will focus on the development of GRI Bio's pipeline and trade on The Nasdaq Capital Market under the ticker symbol "GRI". The transaction is expected to close in the first quarter of 2023. The companies will host a joint webcast on December 14. Concurrently with the execution of the Merger Agreement, Altium Capital has agreed to invest approximately $15M at the close of the Merger purchased from GRI Bio concurrently with the execution of the Merger Agreement and committed to an additional $10M future investment in the combined company.
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MAA | Hot Stocks16:20 EST MAA raises quarterly dividend 12% to $1.40 per share - Payable on January 31, 2023, to shareholders of record on January 13, 2023.
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PHX | Hot Stocks16:19 EST PHX Minerals raises dividend 12.5% to 2.25c - PHX announced a 12.5% increase in its fixed quarterly dividend to 2.25c per share, payable on March 3, 2023, to stockholders of record on Feb. 17, 2023.
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SBSI | Hot Stocks16:18 EST Southside Bancshares increases share repurchase plan by 1M shares - Southside Bancshares announced that its board of directors has increased its authorization under the company's current stock repurchase plan by an additional 1M shares, for a total authorization to repurchase up to 2M shares of the company's common stock from time to time. Under the plan, previously announced March 1, the company has purchased 765,214 shares at an average price of $37.01 through December 12, resulting in approximately 1.2M authorized shares remaining.
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CCRN | Hot Stocks16:16 EST Cross Country Healthcare completes acquisition of Hireup Leadership - Cross Country Healthcare "announced the acquisition of Hireup Leadership Inc. Hireup partners with organizations, including hospitals, academic medical centers, and clinics, to recruit healthcare leaders within nursing, allied, physician, human resources, and finance."
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SHLS | Hot Stocks16:14 EST Shoals Technologies appoints Ben Macias to CRO, Jessica Uecker to CHRO - Shoals Technologies announced the appointments of Jeff Tolnar, Ben Macias and Jessica Uecker to president, chief revenue officer, or CRO, and chief human resources officer, or CHRO, respectively, effective December 19. As senior VP, EV solutions since April, Tolnar has been responsible for expanding Shoals' solar EBOS solutions into the global EV market to enable more economical, efficient and higher quality EV charging infrastructure deployments. As senior VP of sales and marketing for Shoals since January 2021, Macias has been responsible for sales, marketing, and developing go-to-market strategies for international markets. As senior VP, human resources since June 2021, Uecker has overseen Shoals' human resources function leveraging her more than 20 years of extensive HR experience.
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PRAX | Hot Stocks16:11 EST Praxis in strategic epilepsy pact with UCB for up to $100M potential - Praxis Precision Medicines announced a strategic collaboration, based upon Praxis' PRAX-020 program, for the discovery of small molecule therapeutics as potential treatments of KCNT1 related epilepsies. "We are excited to partner with UCB, a global company in epilepsy drug development, as we work together toward a novel approach for the treatment of KCNT1 related epilepsy, which has no approved therapies currently," said Marcio Souza, president and chief executive officer of Praxis. "Our internal research efforts give us confidence that small molecules can selectively inhibit the KCNT1 channel, and potentially could be an effective treatment for individuals suffering from KCNT1 related epilepsy. The collaboration with UCB validates this approach and will allow us to accelerate efforts toward a potential treatment for KCNT1 patients." Under the terms of the collaboration, UCB retains an exclusive option to in-license global development and commercialization rights to any resulting KCNT1 small molecule development candidate. Praxis will receive an upfront payment from UCB, and if the option is exercised by UCB, would be eligible to receive an option fee and future success-based development and commercialization milestone payments, for a total of up to approximately $100M, in addition to tiered royalties on net sales of any resulting products from the collaboration.
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PWR | Hot Stocks16:11 EST Quanta Services raises quarterly dividend 14% to 8c per share - The dividend is payable on January 13, 2023, to stockholders of record as of January 3, 2023.
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GTLB MDB | Hot Stocks16:10 EST GitLab appoints MongoDB CTO Mark Porter to board - GitLab (GTLB) announced the appointment of Mark Porter, CTO at MongoDB (MDB), to its board of directors. Over the last three decades, Porter has focused his career on databases both on the customer side at Grab, NASA, and News Corp, as well as, on the vendor side at MongoDB, AWS, and Oracle. Porter joins the board to add his technology expertise as the company's product strategy evolves to capture more of the DevSecOps market including the incorporation of MLOps and DataOps within its Platform.
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AREN | Hot Stocks16:09 EST Arena Group to buy digital assets of Men's Journal, Adventure Network for $28.5M - The Arena Group Holdings "announced that it has entered into a definitive agreement to acquire the digital assets of Men's Journal, Men's Fitness, Surfer, Powder, Bike, SKATEboarding, Snowboarder and NewSchoolers from accelerate360. The collection of active lifestyle brands, which will provide the core components of The Arena Group's fourth major vertical, has been a staple of those enjoying active and adventurous lives. Under the terms of the acquisition agreement, The Arena Group will pay an aggregate of $28.5 million, including $25 million in cash up front and approximately $3.5 million in deferred payments to acquire these digital assets and assume certain liabilities. The acquisition is expected to be completed Thursday, December 15. "
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PNTG | Hot Stocks16:08 EST Pennant Group announces share repurchase program, terms undisclosed - Pennant Group announced that its board of directors has approved a share repurchase program under which the company may repurchase its common stock.
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GBTG | Hot Stocks16:08 EST Global Business Travel Group chief revenue officer to step down - American Express Global Business Travel, which is operated by Global Business Travel Group, "announced its Chief Revenue Officer Michael Qualantone is to retire after a 34-year career with American Express and Amex GBT. Qualantone will begin transitioning his role on January 1, 2023, to Rajiv Ahluwalia, who becomes Executive Vice President. Ahluwalia has led distribution, content, and revenue management at Amex GBT while playing a critical role in driving the Amex GBT marketplace and NDC capabilities. He will report to Chief Commercial Officer Andrew Crawley. To ensure a smooth transition, Qualantone will remain available to the company as an employee until June 30, 2023."
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SIEN | Hot Stocks16:07 EST Sientra receives United Arab Emirates approval for gel breast impants - Sientra announced that it has received approval from the United Arab Emirates Ministry of Health and Prevention to market the company's line of smooth surface, High-Strength Cohesive silicone gel breast implants in the United Arab Emirates. This new approval marks Sientra's third international expansion this year.
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LIVN | Hot Stocks16:07 EST LivaNova announces receipt of close-out warning letter from FDDA - LivaNova "announced it received a close-out letter from the U.S. Food and Drug Administration for the Warning Letter the Company received on December 29, 2015 that was associated with its Munich, Germany facility and 3T Heater-Cooler(TM) device. Closure of the 2015 Warning Letter represents the culmination of LivaNova's corrective actions implemented at its Munich manufacturing facility and to the 3T Heater-Cooler device design."
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FLO | Hot Stocks16:06 EST Flowers Foods to acquire Papa Pita Bakery - Flowers Foods announced a definitive agreement to acquire Papa Pita Bakery, a manufacturer and distributor of high-quality bagels, tortillas, breads, buns, English muffins, and flat breads. The acquisition, which is subject to regulatory approval and customary closing conditions, is expected to be completed in the Q3 of 2023. Founded in 1983, Papa Pita operates a 270,000 sq. ft. facility in West Jordan, Utah. Papa Pita will continue to operate out of its Utah facility, increasing Flowers' presence in the western United States. Flowers plans to fund the transaction with cash on-hand and existing credit facilities. Deutsche Bank acted as exclusive financial advisor and Jones Day acted as legal counsel to Flowers Foods in this transaction. BofA Securities served as the exclusive financial advisor and Kirton McConkie was legal counsel to Papa Pita in this transaction.
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TTC | Hot Stocks16:06 EST Toro Company raises quarterly dividend by 13% to 34c per share - This dividend is payable on January 11, 2023, to shareholders of record at the close of business on December 28, 2022.
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O | Hot Stocks16:06 EST Realty Income raises monthly dividend to 24.85c from 24.80c per share - The dividend is payable on January 13, 2023, to stockholders of record as of January 3, 2023.
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AMGN | Hot Stocks16:03 EST Amgen announces presentation of results from E1910 randomized Phase 3 trial - Amgen announced the ECOG-ACRIN Cancer Research Group will present results from the E1910 randomized Phase 3 trial. This is the first study to demonstrate superior overall survival, or OS, with BLINCYTO added to consolidation chemotherapy over current standard of care in newly diagnosed adult patients with Philadelphia chromosome-negative B-ALL who were measurable residual disease, or MRD,-negative following induction and intensification chemotherapy. These results were featured in a press briefing on Monday, Dec. 12 as a late breaking oral presentation, or LBA1, at the 64th American Society of Hematology, or ASH, Annual Meeting & Exposition in New Orleans. The Phase 3 randomized trial, or E1910, activated in December 2013, evaluated the safety and efficacy of BLINCYTO added to standard of care consolidation chemotherapy compared to chemotherapy alone in patients with newly diagnosed B-ALL with no MRD after induction and intensification chemotherapy. The primary endpoint was OS and key secondary endpoints included relapse-free survival, MRD status, and incidence of adverse events. Based on a recommendation by the ECOG-ACRIN Data Safety Monitoring Committee and consistent with the pre-defined efficacy threshold, results from the planned interim analysis are now reported due to overwhelming efficacy reported in the BLINCYTO arm. With a median follow up of 43 months, the study met its primary endpoint with a significant improvement in overall survival favoring the BLINCYTO arm; median OS was not reached vs. 71.4 months in the control arm. After about 3.5 years of follow-up, 83% of the patients who went on to receive additional standard consolidation chemotherapy plus experimental BLINCYTO were alive versus 65% of those who received chemotherapy only. No new safety signals were reported for the combination.
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WSC | Hot Stocks16:03 EST WillScot Mobile Mini to divest UK Storage segment to Algeco UK for GBP 335M - WillScot Mobile Mini announced a definitive agreement, whereby the company will divest its UK Storage segment to Algeco UK Holdings, a member of the Modulaire group for an enterprise value of approximately GBP 335M. Proceeds from the sale will be used to support growth investments in the company's North American Modular and Storage operating segments and other capital allocation priorities. Completion of the transaction is subject to regulatory approval in the United Kingdom and is expected to close in the first quarter of 2023. The company does not anticipate any impact to operating results from the divestiture in its NA Modular or NA Storage segments, and the UK Storage segment will be reported as discontinued operations in its Q4 financial filings.
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VLON | Hot Stocks16:02 EST Vallon Pharmaceuticals Inc trading halted, news pending
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QDEL | Hot Stocks15:50 EST QuidelOrtho provides three-year outlook at investor day - Sees FY25 EPS $6.00-$7.00. Sees FY25 adjusted EBITDA margin 27%-29%. Sees three-year target adjusted free cash flow conversion 27%-29%. Sees three-year adjusted EBITDA margin expansion of 25-50 basis points. Comments taken from investor day presentation slides.
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TV | Hot Stocks15:46 EST Grupo Televisa trading resumes
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VNDA TEVA | Hot Stocks15:18 EST Vanda Pharmaceuticals intends to appeal Hetlioz ANDA litigation decision - Vanda Pharmaceuticals (VNDA) responded to the ruling in its Hetlioz ANDA litigation with the following statement: "Vanda has brought several Hatch-Waxman lawsuits in the United States District Court for the District of Delaware against Teva Pharmaceuticals USA, Inc. and Apotex Inc. asserting infringement of patents covering Hetlioz 20 mg capsules. A trial was held in March 2022. Today the Court ruled that Teva and Apotex did not infringe U.S. Patent No. RE46,604, and that the asserted claims of U.S. Patent Nos. RE46,604; 9,730,910; 10,149,829; and 10,376,487 are invalid. Vanda intends to appeal the decision to the United States Court of Appeals for the Federal Circuit and to request a stay of market entry by Teva and Apotex while the appeal is pending. Hetlioz is also approved in the European Union and is not subject to this litigation, nor is generic litigation pending outside of the United States. The litigation does not relate to the Hetlioz LQ oral suspension formulation."
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CTXS | Hot Stocks14:59 EST Citrix releases security updates to address 'critical vulnerability,' CISA says - Citrix has released security updates to address a critical vulnerability, "CVE-2022-27518," in Citrix ADC and Citrix Gateway, the Cybersecurity & Infrastructure Security Agency announced. " An attacker could exploit this vulnerability to take control of an affected system. This vulnerability has been exploited in the wild. CISA encourages users and administrators to review Citrix security bulletin CTX457836 and Citrix's blog post for more information and to apply the necessary updates. Additionally, CISA urges organizations to review NSA's advisory APT5: Citrix ADC Threat Hunting Guidance for detection and mitigation guidance against tools employed by a malicious actor targeting vulnerable Citrix ADC systems," CISA stated in a notice posted to its website. Reference Link
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TV | Hot Stocks14:55 EST Televisa says Megacable rejected combination proposal - In a regulatory notice, Televisa stated: "On December 12, 2022, the Board of Directors of Megacable responded to the proposal from Televisa in writing, informing the Company that it rejected the proposal, noting that the Chairman of the Board of Directors and CEO of Megacable is the only person empowered to deal with this kind of approaches. Despite this response, we believe that the market clearly understands the benefits of this transaction, taking into account the reaction of the markets today to the reports that have appeared in the press related to this proposal. We have received various questions from some Megacable shareholders, and we are excited about your interest in our proposal. We will continue looking for alternatives to dialogue with Megacable regarding this attractive opportunity. Any transaction would be subject to the authorization of the Board of Directors of Televisa and of Megacable, and a usual confirmation audit process (due diligence). The termination of the The transaction would also be subject to the approval of the respective shareholders of both companies, the regulatory authorities and other customary closing conditions. It cannot be guaranteed that such transaction will be finalized or the terms or the moment of the same." Reference Link
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TV | Hot Stocks14:52 EST Televisa confirms talks held with Megacable about potential combination - Grupo Televisa announced that it is aware of press reports regarding a potential merger of its cable business "Televisa Cable" with Megacable Holdings. In a regulatory notice, Televisa stated: "The company today confirmed that it has held bilateral discussions with Megacable from time to time time with respect to a combination, and that on November 14, 2022, it submitted a proposal not binding of the transaction to the Board of Directors of Megacable. Televisa's proposal contemplates a merger of Televisa Cable into Megacable through a share exchange at a premium of approximately 19% for Megacable shareholders, in which the shareholders of Megacable and Televisa would own approximately 45% and 55% of the combined company, respectively. The proposal also includes the possibility that, at the close of the transaction, Megacable shareholders receive a special cash dividend of approximately MXN$14.8 billion. Megacable would continue to be listed on the Mexican stock market as the entity resulting from the merger. The Company believes that the proposed transaction may represent benefits significant for both companies and their shareholders. The combination would create a leading cable operator in Mexico, better positioned to compete in a highly competitive market." Reference Link
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TV | Hot Stocks14:43 EST Grupo Televisa trading halted, news pending
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MTCH... | Hot Stocks14:40 EST Match Group up 8% after Bloomberg report on Apple App store plans - Shares of Match Group (MTCH) are up 8% to $47.17 and those of Bumble (BMBL) are up more than 2% to $24.07 after Bloomberg's Mark Gurman reported that Apple (AAPL) is getting ready to allow alternative app stores on its iPhones and iPads as part of an overhaul to comply with strict European Union requirements that are coming in 2024.
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SNAP... | Hot Stocks13:52 EST Rubio, Gallagher introduce bipartisan legislation to ban TikTok - U.S. Senator Marco Rubio and U.S. Representatives Mike Gallagher said, in part: "TikTok's Chinese parent company, ByteDance, is required by Chinese law to make the app's data available to the Chinese Communist Party . From the FBI Director to FCC Commissioners to cybersecurity experts, everyone has made clear the risk of TikTok being used to spy on Americans. U.S. Senator Marco Rubio R-FL introduced bipartisan legislation to ban TikTok from operating in the United States. The Averting the National Threat of Internet Surveillance, Oppressive Censorship and Influence, and Algorithmic Learning by the Chinese Communist Party Act would protect Americans by blocking and prohibiting all transactions from any social media company in, or under the influence of, China, Russia, and several other foreign countries of concern. U.S. Representatives Mike Gallagher R-WI and Raja Krishnamoorthi D-IL introduced companion legislation in the U.S. House of Representatives."The federal government has yet to take a single meaningful action to protect American users from the threat of TikTok. This isn't about creative videos - this is about an app that is collecting data on tens of millions of American children and adults every day." Other publicly traded companies in the space include: Snap (SNAP). Alphabet (GOOG, GOOGL), Meta Platforms (META), Microsoft (MSFT) and Twitter (TWTR). Reference Link
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SNAP META | Hot Stocks13:40 EST Instagram rolls out Notes for short messaging - Instagram (META) blogged earlier, in part: "Whether it's catching up with friends or exploring shared interests, connecting with others is why people come to Instagram.. we're introducing several updates to help you feel closer to the people you care about. We're beginning to roll out Notes, a new way to share your thoughts and see what your friends are up to. Notes are short posts of up to 60 characters using just text and emojis. To leave a note, go to the top of your inbox, select the followers you follow back or people on your Close Friends list, and your note will appear at the top of their inbox for 24 hours. Replies to notes will arrive as DMs in your inbox...People enjoy sharing throughout their day to Stories - from highlights to the more everyday moments. We're testing new features in Stories to help people more easily share in spontaneous, fun ways to help create even stronger connections with friends. Other companies in the space include Snap (SNAP). Reference Link
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ALB | Hot Stocks13:38 EST Albemarle to invest at least $180M in technology park for advanced lithium - Albemarle announced it has acquired a location in Charlotte, North Carolina, where it will invest at least $180M to establish the Albemarle Technology Park, which it describes as "a world-class facility designed for novel materials research, advanced process development, and acceleration of next-generation lithium products to market." The company anticipates that "innovations from the new site will enhance lithium recovery, improve production methods, and introduce new forms of lithium to enable breakthrough levels of battery performance," Albemarle stated in a press release.
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CLF | Hot Stocks13:23 EST Cleveland-Cliffs announces price increase for steel products - Cleveland-Cliffs announced that it is increasing current spot market base prices for all carbon hot rolled, cold rolled and coated steel products by a minimum of $50 per net ton, effective immediately with all new orders. Cliffs' minimum base price for hot rolled steel is now $750 per net ton. This additional price increase is in response to market feedback following the Company's November price increase, as well as improving dynamics in the raw materials and distribution markets.
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DNKEY | Hot Stocks12:34 EST Danske Bank forfeits $2B in guilty plea with Justice Department - Danske Bank pleaded guilty and agreed to forfeit $2B to resolve the United States' investigation into Danske Bank's fraud on U.S. banks, the Department of Justice said in a statement. According to court documents, Danske Bank defrauded U.S. banks regarding Danske Bank Estonia's customers and anti-money laundering controls to facilitate access to the U.S. financial system for Danske Bank Estonia's high-risk customers, who resided outside of Estonia - including in Russia, according to the agency. The Justice Department will credit nearly $850M in payments that Danske Bank makes to resolve related parallel investigations by other domestic and foreign authorities. Reference Link
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SOXS | Hot Stocks12:00 EST Direxion Daily Semiconductor Bear 3X Shares falls -7.9% - Direxion Daily Semiconductor Bear 3X Shares is down -7.9%, or -$2.46 to $28.86.
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SI | Hot Stocks12:00 EST Silvergate Capital falls -10.8% - Silvergate Capital is down -10.8%, or -$2.29 to $18.96.
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EWT | Hot Stocks12:00 EST Shares MSCI Taiwan Index Fund falls -15.1% - Shares MSCI Taiwan Index Fund is down -15.1%, or -$7.50 to $42.21.
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GATO | Hot Stocks12:00 EST Gatos Silver rises 11.4% - Gatos Silver is up 11.4%, or 47c to $4.58.
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PINS | Hot Stocks12:00 EST Pinterest rises 11.5% - Pinterest is up 11.5%, or $2.73 to $26.34.
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TV | Hot Stocks12:00 EST Televisa rises 12.9% - Televisa is up 12.9%, or 62c to $5.43.
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CWBR | Hot Stocks11:52 EST CohBar treatment of idiopathic pulmonary fibrosis granted orphan status - CohBar's treatment of idiopathic pulmonary fibrosis, or IPF, was granted orphan status by the FDA, according to a post to the agency's website. Reference Link
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KTOS | Hot Stocks11:26 EST Kratos Defense selected as engine design team for collaboration on Symphony - Kratos Defense & Security Solutions announced Florida Turbine Technologies has been chosen as the engine design team for the Boom-led collaboration on Symphony, a new propulsion system to be designed and optimized for Boom Supersonic's Overture supersonic airliner. Symphony will be a bespoke design leveraging proven technologies and materials to achieve optimal supersonic performance and efficiency. Overture's new propulsion system is expected to operate at net zero carbon and meet Chapter 14 noise levels. When compared to derivative approaches, Symphony is also expected to deliver a 25% increase in time on wing and significantly lower engine maintenance costs, reducing overall airplane operating costs for airline customers by 10%.
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PCRX | Hot Stocks11:21 EST Pacira sinks after continuing to not provide outlook with monthly sales - Pacira BioSciences, when reporting November net product sales of $57.5M earlier today, said it is still not providing 2022 revenue or gross margin guidance "at this time given the continued uncertainty around labor shortages, COVID-19, and the pace of recovery for the elective surgery market." It added, "To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for Exparel, Zilretta and iovera until it has gained enough visibility around the impacts of COVID-19." Pacira explained that since early 2020, its revenues have been impacted by COVID-19 and pandemic-related challenges "that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives." While the degree of impact has diminished during the course of the pandemic, "certain pandemic-related operational challenges persist," the company said. "It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise," it added. Shares of Pacira are down 7% to $42.11 in late morning trading.
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PCRX | Hot Stocks11:02 EST Pacira sinks after continuing to not provide 2022 with monthly sales - Pacira BioSciences, when reporting November net product sales of $57.5M earlier today, said it is still not providing 2022 revenue or gross margin guidance "at this time given the continued uncertainty around labor shortages, COVID-19, and the pace of recovery for the elective surgery market." It added, "To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for Exparel, Zilretta and iovera until it has gained enough visibility around the impacts of COVID-19." Pacira explained that since early 2020, its revenues have been impacted by COVID-19 and pandemic-related challenges "that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives." While the degree of impact has diminished during the course of the pandemic, "certain pandemic-related operational challenges persist," the company said. "It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise," it added. Shares of Pacira are down 7% to $42.11 in late morning trading.
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MS SCHW | Hot Stocks10:51 EST E*TRADE from Morgan Stanley eliminates commissions for all online mutual funds - E*TRADE from Morgan Stanley has announced it will eliminate all trade commissions and early redemption fees for mutual fund online trades on its platform. "The ability to add mutual funds to the list of E*TRADE's no commission offerings is another proof point that joining Morgan Stanley has provided substantial benefits to clients as we aim to offer the best investing experience possible," said Chad Turner, Head of Morgan Stanley Wealth Management's Digital Direct Channel. "E*TRADE has a long history of being an innovator in the industry and we are proud to be able to advance this narrative even further as part of Morgan Stanley." E*TRADE from Morgan Stanley offers over 6,500 commission-free mutual funds. Clients can use the Fund Screener to find funds that match their goals and investment strategies. The commission-free Mutual Fund offering will be effective for all online mutual fund trades executed on or after December 12, 2022.
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CHH SWK | Hot Stocks10:37 EST Choice Hotels names Sally Bartas as chief talent and culture officer - Choice Hotels International (CHH) has appointed Sally Bartas to the position of chief talent and culture officer. In this newly created role, Bartas will report directly to the company's chief human resources officer and work closely with leaders across the enterprise to strategically expand Choice's talent programs and forward-thinking HR strategies, including workforce planning, succession planning, and talent management and acquisition, the company said in a statement. Bartas joins Choice Hotels from Stanley Black and Decker (SWK), where she most recently served as vice president of human resources.
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VNDA | Hot Stocks10:30 EST Vanda weakness attributed to court opinion in Hetlioz patent case - Vanda Pharmaceuticals shares are up down 7% to $10.05 in morning trading, which Bloomberg attributes as being related to a court opinion being issued in a Hetlioz patent case.
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WORX | Hot Stocks10:28 EST SCWorx granted 180-day extension to meet Nasdaq minimum bid price requirement - SCWorx Corp received written notification from the Listing Qualification Department of The Nasdaq Stock Market LLC granting the company's request for a 180-day extension to regain compliance with Nasdaq's minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The company now has until June 5, 2023 to meet the requirement. Nasdaq's extension notice has no immediate effect on the continued listing status of the company's common stock on The Nasdaq Capital Market LLC under the symbol "WORX". If at any time during the additional 180-day extension, the bid price of the company's common stock closes at, or above, $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff will provide the company with a written confirmation of compliance and the matter will be closed.
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NUVL | Hot Stocks10:17 EST Nuvalent announces publication detailing design of NVL-520 - Nuvalent announced the publication of a manuscript in Cancer Discovery, a journal of the American Association for Cancer Research, which describes the design and characterization of NVL-520 and details Nuvalent's approach to rationally targeting ROS1. NVL-520 is currently being studied in the ongoing ARROS-1 Phase 1/2 clinical trial for patients with advanced ROS1-positive non-small cell lung cancer and other solid tumors. The paper details the design principles underlying the activity of NVL-520 against ROS1 and its most commonly occurring resistance mutation, ROS1 G2032R, and a molecular rationale for the selectivity of NVL-520 for ROS1 over the structurally-related TRK family. TRK inhibition in the CNS by approved or investigational ROS1 TKIs has been associated with neurological adverse events that can be dose limiting. Extensive preclinical characterization of the activity and selectivity of NVL-520 is presented, spanning biochemical and cellular assays, in vivo xenograft studies, and preclinical assessments of brain penetrance and intracranial activity. In addition, the paper includes three case studies of patients with ROS1 fusion-positive lung cancers that had relapsed on or were refractory to a range of ROS1 TKIs, and includes patients with tumors that harbored ROS1 G2032R or had intracranial metastases. NVL-520 elicited tumor responses in the patients with no observed neurological toxicities. These findings support the potential for NVL-520 to treat these patient populations while also enhancing tolerability through improved selectivity for ROS1.
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PBIO | Hot Stocks10:09 EST Pressure BioSciences announces shipment of UltraShear nanoemulsion product - Pressure BioSciences confirmed the shipment of the Company's first ever commercial production lot of a anoemulsion product created and enabled by the company's Ultra Shear Technology nanoemulsification platform. The shipped product is a CBD oral spray designed by PBI for fast effect and high potency for Safer Medical of Montana, with whom PBI signed a multi-year development and manufacturing agreement, announced on May 4, 2022. SMM pre-paid the entire $75,000 purchase price of the Phase I production lot. The Agreement covers three phases of development and commercialization of a custom-formulated oral spray of hemp-derived nanoemulsified CBD designed for extremely rapid absorption and effectiveness, and for efficient high potency delivery of CBD active material in each dose. All ingredients used in the manufacture of this UltraShear prepared nanoemulsion product are sourced from naturally-occurring, plant-based origins. Phases II and III of the PBI-SMM Agreement are focused on scaling up UltraShear nanoemulsion production by a factor of 10x in each stage, with total PBI revenues captured under this Agreement expected to top $1M in Q1/Q2 of 2023.
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OPCH | Hot Stocks10:06 EST Option Care Health expands partnership with WellSky - WellSky is significantly expanding its partnership with Option Care Health. Option Care Health will collaborate with WellSky to accelerate innovations and workflow enhancements within WellSky's infusion and specialty pharmacy platform, CareTend, and will implement the software across its more than 160 Option Care Health locations.
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BGNE | Hot Stocks10:05 EST BeiGene says Brukinsa shows superior efficacy versus Imbruvica in study - BeiGene presented the final progression-free survival analysis of the ALPINE trial "demonstrating superior efficacy and a favorable cardiac safety profile" for patients receiving Brukinsa as compared to Imbruvica in a Phase 3 trial in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic leukemia. The data will be presented during the late-breaking session at the American Society of Hematology Annual Meeting in New Orleans and simultaneously published in The New England Journal of Medicine. In the final analysis, Brukinsa achieved superior PFS over ibrutinib, BeiGene said in a statement. At 24 months, the investigator-assessed PFS rates were 78.4% for Brukinsa compared to 65.9% with ibrutinib. The PFS benefit was observed across all major subgroups. Brukinsa was generally well-tolerated with fewer adverse events leading to treatment discontinuation compared with ibrutinib, the company adds.
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PCYG | Hot Stocks10:05 EST Haven Foods selects ReposiTrak's traceability solution - ReposiTrakhas welcomed Haven Foods, LLC, to its ReposiTrak Traceability Network, the solution backed by the industry for being easy to adopt and the lowest cost possible. Joining the Network enables Haven Foods to seamlessly exchange traceability information from feed to store between its fresh and frozen seafood suppliers and producers and its retail and restaurant clients across the world, helping it meet and exceed the Food and Drug Administration's recently finalized Food Safety Modernization Act Section 204 rule on traceability.
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GE | Hot Stocks10:04 EST ELPEDISON selects GE Digital APM reliability application - GE Digital announced that ELPEDISON S.A., the first independent energy producer in Greece, has chosen its cloud-based Asset Performance Management Reliability application to improve the reliability of its combined cycle fleet. The software will be installed at ELPEDISON's Thisvi and Thessaloniki power plants, making it the first energy company in the country to cover an entire combined cycle plant with digital twin technology.
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NVS | Hot Stocks10:03 EST Novartis reports Phase 3 APPLY-PNH trial met both primary endpoints - Novartis announced detailed results from the pivotal Phase 3 APPLY-PNH trial. The results showed a vast majority of patients with paroxysmal nocturnal hemoglobinuria, or PNH, who received the investigational oral monotherapy iptacopan achieved clinically meaningful increases in hemoglobin levels compared to anti-C5 therapy. The study met both primary endpoints and most secondary endpoints, with iptacopan demonstrating superiority over anti-C5 therapy in adult patients with PNH experiencing residual anemia despite prior treatment with anti-C5 therapy. The study met both primary endpoints, showing superiority for iptacopan vs. anti-C51. For the first, an estimated 82.3% of iptacopan-treated patients achieved hemoglobin-level increases of 2 g/dL or more from baseline without the need for red blood cell transfusions, compared to an estimated 2.0% of anti-C5-treated patients: an estimated 80.3% difference in favor of iptacopan. The observed number of patients achieving this primary endpoint was 51/60# for iptacopan vs. 0/35 for anti-C5. For the second primary endpoint, an estimated 68.8% of iptacopan-treated patients achieved hemoglobin levels of 12 g/dL or more without the need for blood transfusions, compared to an estimated 1.8% of anti-C5-treated patients: an estimated 67.0% difference in favor of iptacopan. The observed number of patients achieving this primary endpoint was 42/60# for iptacopan vs. 0/35 for anti-C5.
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RIGL | Hot Stocks10:02 EST Optime Care announces enhanced partnership with Rigel Pharmaceuticals - Optime Care announced a contractual partnership with Rigel Pharmaceuticals, Inc., bringing its full suite patient support/HUB service capabilities to support Rezlidhi, a recent FDA-approved treatment for adult patients with relapse or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test. Optime Care's services for life sciences manufacturers include pre-commercialization and market access expertise, exclusive distribution partnerships, national medication fulfillment and high-touch patient support and HUB services for enhanced patient outcomes.
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LHX | Hot Stocks10:01 EST L3Harris awarded potential $886M contract supporting battlespace ISR - The U.S. Army Communications-Electronics Command awarded L3Harris Technologies a contract worth up to $886M to support intelligence, surveillance and reconnaissance capabilities for the Army, Department of Defense and intelligence community. The indefinite delivery, indefinite quantity contract includes a five-year base award with five one-year follow-on options to provide datalink architecture, network design enhancements for aerial and ground-based communications, and lifecycle management support.
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BAESY | Hot Stocks10:01 EST BAE Systems awarded $13.5M contract from U.S. Navy - The U.S. Navy has awarded BAE Systems $13.5M to incorporate its Smart D2 technology as part of the U.S Navy's ALE-47 Common Carriage program which increases expendable payload capacity as the service converts from round to square countermeasures. The contract is an Other Transaction Agreement through the Naval Aviation Systems Consortium. This is the first purchase of Smart D2 technology by the Department of Defense.
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TZA | Hot Stocks10:00 EST Small Cap Bear 3x falls -9.8% - Small Cap Bear 3x is down -9.8%, or -$3.17 to $29.05.
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SOXS | Hot Stocks10:00 EST Direxion Daily Semiconductor Bear 3X Shares falls -13.8% - Direxion Daily Semiconductor Bear 3X Shares is down -13.8%, or -$4.33 to $26.99.
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EWT | Hot Stocks10:00 EST Shares MSCI Taiwan Index Fund falls -14.4% - Shares MSCI Taiwan Index Fund is down -14.4%, or -$7.17 to $42.54.
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NOVA | Hot Stocks10:00 EST Sunnova Energy rises 13.8% - Sunnova Energy is up 13.8%, or $2.90 to $23.90.
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SOXL | Hot Stocks10:00 EST Direxion Daily Semiconductor Bull 3X Shares rises 14.2% - Direxion Daily Semiconductor Bull 3X Shares is up 14.2%, or $1.84 to $14.82.
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MCG | Hot Stocks10:00 EST Membership Collective rises 14.7% - Membership Collective is up 14.7%, or 58c to $4.52.
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DRV | Hot Stocks09:47 EST Debt Resolve falls -9.3% - Debt Resolve is down -9.3%, or -$4.62 to $44.95.
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SOXS | Hot Stocks09:47 EST Direxion Daily Semiconductor Bear 3X Shares falls -11.7% - Direxion Daily Semiconductor Bear 3X Shares is down -11.7%, or -$3.65 to $27.67.
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EWT | Hot Stocks09:47 EST Shares MSCI Taiwan Index Fund falls -14.5% - Shares MSCI Taiwan Index Fund is down -14.5%, or -$7.21 to $42.50.
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CVNA | Hot Stocks09:47 EST Carvana rises 11.2% - Carvana is up 11.2%, or 56c to $5.51.
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SOXL | Hot Stocks09:47 EST Direxion Daily Semiconductor Bull 3X Shares rises 12.1% - Direxion Daily Semiconductor Bull 3X Shares is up 12.1%, or $1.57 to $14.55.
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HUYA | Hot Stocks09:47 EST Huya rises 12.7% - Huya is up 12.7%, or 36c to $3.20.
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KSCP | Hot Stocks09:46 EST Knightscope announces contracts for ASRs, Blue Light Towers, Call Boxes - Knightscope announces the largest single contract in the Company's history alongside 2 new contracts from cities in New York and Georgia. The contracts consist of 12 K5 Autonomous Security Robots, 2 K1 Blue Light Towers and 2 K1 Call Boxes. A key decision-making factor for the larger client was the K5's capabilities that are not part of the current security program. The company will be deploying ASRs as part of an overall "layered" approach to give them unprecedented eye-level views and coverage. The ASRs will deter crime, criminal trespassing and loitering while providing their employees with greater personal safety. The two cities electing to expand their communication capabilities selected Knightscope K1 Blue Light Emergency Towers and Emergency Call Boxes using cellular and satellite communications with solar power to provide additional safety in remote locations. These newer, more advanced wireless systems will save end users money on both infrastructure and hardware costs, while improving reliability on a modern communication network.
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OPAL | Hot Stocks09:40 EST Opal Fuels Inc trading resumes
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BLZE | Hot Stocks09:32 EST Backblaze announces new data region in the Eastern U.S. - Backblaze expanded with a new data region in the Eastern United States. The U.S. East data region provides more location choice overall, bringing increased access speed for customers based in the Eastern U.S. and greater geographic separation for backup data stored by businesses operating in other regions. The new region also helps provide an additional destination for businesses seeking to store copies of their datasets to two or more cloud locations for compliance and continuity needs. This Cloud Replication service is provided with free data egress, enabling customers to copy data across the Backblaze platform at no expense. Data stored in U.S. East will reside in Backblaze's newest data center, IAD 1, located in Reston, Virginia. This data center features an exabyte of capacity with room to grow further, and supports SOC 2 Type 2, ISO 27001, NIST 800-53, and HIPAA compliance requirements to help ensure that data in the East region is safe and readily available for Backblaze customers.
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VINC | Hot Stocks09:30 EST Vincerx Pharma announces FDA safe to proceed letter, clearance for VIP236 IND - Vincerx Pharma announced that the U.S. Food and Drug Administration has provided a safe to proceed letter and cleared the IND application for VIP236, the Company's front-runner SMDC for the treatment of advanced solid tumors. VIP236 is a first-in-class SMDC with a tailored design to efficiently treat patients with cancer with aggressive and metastatic disease. VIP236 binds to activated alphaVbeta3 integrin allowing specific homing to the tumor and is efficiently cleaved by neutrophil elastase. Both proteins are present in the tumor microenvironment, are highly expressed in advanced metastatic tumors, and are associated with poor prognosis in patients with cancer. Anticancer activity occurs after a specific and targeted release of an optimized camptothecin payload by NE in the TME. The CPT payload of VIP236 is optimized for high permeability with low active efflux potential to overcome transporter-mediated resistance observed with SN38, the active metabolite of irinotecan.
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OPAL | Hot Stocks09:30 EST Opal Fuels Inc trading halted, volatility trading pause
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XAIR | Hot Stocks09:28 EST Beyond Cancer announces publication of pre-clinical data on tumor ablation tech - Beyond Cancer announced the publication of pre-clinical data demonstrating that its proprietary tumor ablation technology utilizing UNO results in a potent innate and adaptive immune response that prevents metastases and resulted in a statistically significant survival benefit. The data were published in an article entitled, "Gaseous Nitric Oxide Tumor Ablation Induces an Anti-Tumor Abscopal Effect," in the peer-reviewed journal Cancer Cell International. The manuscript published in CCI describes several studies of in-vitro and in-situ tumor ablation utilizing a single intratumoral treatment of UNO with secondary anti-tumor effects. In one study, CT26 tumor-bearing mice were treated with a single 5-minute administration of 50,000 ppm gaseous nitric oxide or 20,000 ppm gNO versus naive control. Two weeks post gas treatment, the tumors were resected and a week later a secondary tumor was induced in the contralateral flank. As shown in the figure below at day 55, all of the mice treated with 50,000 ppm gNO rejected the secondary CT26 cell inoculation versus none of the mice in the naive group. In addition, 73% of the mice treated with 20,000 ppm gNO rejected the secondary inoculation, also a significantly better result than naive control. By Day 75, the conclusion of the study, 89% of the mice treated with 50,000 ppm gNO and 64% of the mice treated with 20,000 ppm gNO rejected a secondary inoculation, compared to none of the mice in the naive group. The Kaplan-Meier analysis in the figure above shows statistical significance for survival in UNO treated CT26 tumor-bearing mice versus control. There was also a separation between the 50,000 ppm arm and the 20,000 ppm arm implying a potential dose response.
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SQL | Hot Stocks09:26 EST SeqLL appoints Brian Paras as CBO - SeqLL announced that Brian Paras has joined the company as Chief Business Officer. Prior to joining SeqLL, Mr. Paras held senior commercial leadership positions with life-science technology providers including Affymetrix, Covaris, Helicos Biosciences, Nabsys, and Caliper Life Sciences.
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WBEV | Hot Stocks09:26 EST Winc files voluntary petitions for relief under Chapter 11 - In a regulatory filing, Winc said that on November 30, 2022, it filed voluntary petitions for relief under Chapter 11 of Title 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware. The Debtors continue to operate their business as debtors in possession under the jurisdiction of the Bankruptcy Court. As previously announced, at a hearing on December 6, 2022, the Debtors received interim approval to enter into a debtor-in-possession facility provided by Project Crush Acquisition Corp LLC, a Delaware limited liability company, comprising a $5.0 million term loan, of which $2.0 million will be available pending final approval by the Bankruptcy Court, which will be pari passu with the Debtors' prepetition secured loan with Banc of California, N.A. On December 7, 2022, the Debtors entered into an asset purchase agreement with PCAC, pursuant to which PCAC agreed, subject to the terms and conditions contained in the Agreement, to purchase certain specified assets of the Debtors related to the Debtors' business and assume certain specified liabilities of the Debtors. Under the Agreement, PCAC has agreed to serve as a "stalking horse bidder," whereby the Agreement will serve as a baseline by which other offers may be measured in a potential open auction process conducted in accordance with the Code. The Agreement provides a cash purchase price for the Transaction in an amount equal to $10.0 million to be paid at the closing of the Transaction, which amount will be reduced by the aggregate amount of any unpaid and outstanding obligations under the DIP Facility, as well as certain fees, costs and expenses. The Transaction, including the designation of PCAC as the stalking horse bidder, is subject to the approval of the Bankruptcy Court. Also on December 7, 2022, the Debtors filed a motion with the Bankruptcy Court seeking an order, among other things, approving proposed bidding procedures and authorizing the Debtors to schedule an auction to sell all or substantially all of the Debtors' assets and scheduling a hearing to approve such sale.
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WBEV | Hot Stocks09:25 EST NYSE American to suspend trading immediately in Winc - NYSE American announced that the staff of NYSE Regulation has now determined to immediately suspend trading in the common shares of Winc, Inc. - ticker symbol WBEV - from the Exchange. On December 5, the NYSE American announced that it was commencing proceedings to delist the company. The company had the right to request a review of this determination by a Committee of the Board of Directors of the Exchange. On December 12, the company confirmed that it will not exercise that right. Accordingly, the NYSE American will now suspend trading in the common shares and will file a delisting application with the Securities and Exchange Commission. Reference Link
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EVC | Hot Stocks09:20 EST Entravision unit Smadex names Phil Gontier Chief Revenue Officer - Smadex, an Entravision company welcomes Phil Gontier as Chief Revenue Officer. Phil joins Smadex following six years of leading Liftoff to become one of the largest global programmatic ad platforms for Apps, Games and Brands. Blackstone took a majority stake in Liftoff in 2021.
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AEHA OCEA | Hot Stocks09:20 EST Aesther Healthcare Acquisition to extend period to consummate combination - As previously announced, on August 31, 2022, Aesther Healthcare Acquisition Corp. entered into definitive merger agreement with Ocean Biomedical, Inc. Aesther announced today that its Board of Directors has approved an extension of the period of time available to Aesther to consummate a business combination by three months from December 16, 2022 to March 16, 2022, as permitted under Aesther's governing documents. In connection with the Second Extension, Aesther's sponsor, Aesther Healthcare Sponsor, LLC, has agreed to deposit an aggregate of $1,050,000 into Aesther's Trust account for its public stockholders, representing $0.10 per public share, by December 16, 2022, which will be in the form of a loan. Aesther's governing documents permit a total of two three-month extensions, of which this is the second.
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ARQQ DELL | Hot Stocks09:19 EST Arqit Quantum partners with Dell for quantum-safe solutions - Arqit Quantum (ARQQ) signed with Dell Technologies (DELL) a "Dell OEM Engineered Solutions Pilot Agreement". Dell agrees to preload Arqit's QuantumCloud software on selected Dell hardware devices, enabling Dell sales teams to sell the combined hardware and software as a single SKU to address existing and new customer needs. The initial target market is the US Federal Government, including the Department of Defense, the Federal Civilian Agencies and the Intelligence Community. Dell sales teams will be able to offer Arqit QuantumCloud software and Arqit sales teams will be able to offer Dell hardware and services in their sales portfolios.
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WTER | Hot Stocks09:18 EST Alkaline Water adds two new direct-store-delivery partners - The Alkaline Water Company announced that it has added two new direct-store-delivery partners, C&M Sales and Alber & Leff Foods Company to cover the entire state of Arkansas and Western Pennsylvania, respectively. Alkaline88 now has DSD coverage in fourteen states as it continues to grow sales in the convenience and grocery channels. "The addition of two great new DSD partners will help Alkaline88 continue to grow in important regional grocery chains as well as earn shelf space in more of the 150,000 convenience stores in the country," said Frank Lazaran, President and CEO of The Alkaline Water Company.
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AVYA RNG | Hot Stocks09:18 EST Avaya appoints RingCentral board nominee to board, says committed to partnership - Avaya (AVYA) publicly disclosed certain business information that it confidentially shared with certain of its financial stakeholders. This information was shared in connection with ongoing constructive discussions Avaya is having with its financial stakeholders regarding a comprehensive resolution to strengthen the Company's balance sheet and position the business for long-term success. Alan Masarek, Avaya's CEO, said, "We are pleased to remain engaged in constructive discussions with all of our financial stakeholders to enhance our capital structure, increase liquidity and accelerate our investment in innovative products and solutions. Avaya benefits from an iconic brand, massive partner ecosystem and a truly global footprint, and we are confident the steps we are taking are in the best interest of our business and our stakeholders." Avaya announced that Jill Frizzley has been appointed to its board of directors, effective immediately. Frizzley is a corporate governance expert with over two decades of experience serving on boards and advising on financial restructuring and mergers and acquisitions. Frizzley was nominated to Avaya's board by RingCentral (RNG), pursuant to their strategic partnership. The company remains committed to a strategic partnership with RingCentral.
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BWAY | Hot Stocks09:18 EST Brainsway reports open market stock purchase by board member - BrainsWay reported a recent open market purchase of BrainsWay American Depositary Receipts by Yossi Ben Shalom, an independent Director on the Company's Board. Ben Shalom purchased 147,500 ADRs on the open market for a total amount of $277,300, at an average price of $1.88 per ADR. The ADR purchase was made on the Nasdaq exchange, and follows recent open market stock purchases by additional BrainsWay board members, including its Chairman, Dr. David Zacut, and Avner Hagai. The Company's ordinary shares are listed and traded on the Tel Aviv Stock Exchange.
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ARAAF | Hot Stocks09:15 EST Aclara Resources provides update on greenfield exploration plan - Aclara Resources provides an update on its greenfield exploration. In parallel with the development of the Penco Module, the Company intends to define additional opportunities to increase potential future rare earth element production via intensive greenfield exploration programmes and the development of additional project "modules" within the Company's concessions. Based on the results of the mapping and sampling works performed in 2021, the Company identified the presence of regolith formations and rare earth element mineralization within the Veronica, Catalina and Petronila districts. The initial success from the mapping exploration works was complemented by a multi-element geophysics radiometry and magnetometry fly-over that covered most of the Company's mining concessions. Survey results were delivered at the end of the first quarter of 2022 and resulted in the generation of new prospective targets throughout the Company's concessions package. During Q2, Q3 and Q4 2022, further geological and regolith mapping was carried out in the Petronila and Veronica districts, where over 40,000 hectares of mining concessions were assessed for the presence of mineralization. This is associated with the geochemical analysis of superficial samples which has identified new areas of interest for a sonic drilling campaign and resulted in total of 28 targets being proposed for further drilling. As at YTD 2022, a total of 125 holes and 3,787 metres have been drilled within the Veronica District as part of the Company's 2022 greenfield exploration initiative. Preliminary results indicate continuity of mineralization with drill hole spacing of between 35 meters and 300 meters and shows mineralization occurring at a depth of between 2 and 10 meters below the surface. The Company intends to report the results of this drilling campaign in the first quarter of 2023. The Company is excited to present a robust budget of US$5.9 million to fund ongoing exploration activities within the Veronica and Petronila districts in 2023 to support its aspiration of adding additional modules to the current Penco module. In addition, the Company has recently decided to initiate Ionic Clays prospectivity exploration in other countries within South America, including Brazil, Colombia and Peru, which will be assessed in 2023 for future drilling campaigns.
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WBEV | Hot Stocks09:15 EST Winc Inc trading halted, news dissemination
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IBEX | Hot Stocks09:12 EST Ibex appoints Thigpen as SVP of Channel Partnerships - ibex announced that it has strengthened its investment in serving channel clients with the hiring of Michael Thigpen as Senior Vice President, SVP, of Channel Partnerships. In this key role, Thigpen will be responsible for growing ibex's worldwide channel strategy and engagements. His primary duties will include creating new programs and incentives for strategic channel partner clients such as Zendesk, Uipath and Talkdesk.
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AZ | Hot Stocks09:10 EST A2Z announces 30% increased advanced smart cart order from Yochananof - A2Z Smart Technologies announces that it has received an increased purchased order of 30% from a leading grocery chain M. YOCHANANOF AND SONS. This now brings the total order to 1,300 smart carts and total aggregate revenues to approximately New Israeli Shekels 35M or or $12M. Pricing and delivery terms are in line with the original agreement and payment will be made in advance for each batch of smart carts delivered. To date, Yochananof has paid the Company approximately NIS 20M, USD $5.8m. Delivery of the initial purchase order continues at pace with 11 Yochananof stores now utilizing the Cust2MatSmart Cart solution. The Company anticipates completion of the initial purchase order and the increased purchased order by the end of Q223.
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LPLA | Hot Stocks09:10 EST LPL Financial: Harbor Lighthouse Wealth joins RIA, custodial platforms - LPL Financial LLC announced that financial advisors David Rimkus, Donald Sharko and Thomas Phelan have joined LPL Financial's broker-dealer, RIA and custodial platforms, aligned with Financial Resources Group Investment Services. They reported having served approximately $285 million in advisory, brokerage and retirement plan assets, and join LPL from LaSalle St. Securities. Based in Orland Park, Ill., Rimkus launched the practice in 1997 after spending 10 years in banking. The business has grown over time, shifting from a transactional brokerage firm to a comprehensive wealth management firm that serves multigenerational clients. All three advisors grew up in Chicago and have a rich understanding and knowledge of the community. Rounding out the team are Operations Manager Emily Malfeo, who is Rimkus' daughter, along with Client Services Associate Debra Lapaglia.
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EEFT | Hot Stocks09:09 EST Euronet announces Ren Payments Platform selected by BNC - Euronet Worldwide announced its Ren Payments Platform will serve as the foundational technology for the digital payments transformation strategy at Bank Neo Commerce, BNC, one of the leading digital banks in Indonesia. BNC selected Euronet and Ren to help make its digital payments faster, accessible and safer for its customers. Retail digital payment transactions in Indonesia have grown 500% from $14B to $72B in the past 5 years with projections for further growth by 60-80% over the next 4-5 years, making Indonesia one of the top countries in the world in regard to rapidly growing digital payments usage. Adoption of BNC's products and services are also growing with quick adoption in terms of downloads, daily active users and monthly active users in Indonesia. As of June 2022, BNC had 18.4 million total customers with monthly active users reaching 3 million. The company hopes to add 15 million new customers by the end of 2022.
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MOBQ | Hot Stocks09:08 EST Mobiquity Technologies to launch new SaaS suite of products - Mobiquity Technologies announces its new and innovative focus into the AdTech Publisher ecosystem with the upcoming launch of the Mobiquity Suite for Publishers. Dean Julia, CEO of Mobiquity Technologies, said "We believe there is a major paradigm shift occurring and the market is ripe for it. The intelligence and the data residence must shift from demand-side solutions to publishers and publisher aggregators directly. Publishers must become owners of their first party data and manage the audiences in-house. Irrespective of whether a publisher chooses to work with us or not, it is prudent for them to find a solution that enables advertisers to do direct buys from them."
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IMMR | Hot Stocks09:08 EST Immersion renews multi-year license with Dongwoon Anatech - Immersion announced that it renewed a multi-year license with Dongwoon Anatech, which creates analog integrated circuits, or ICs, for phones, wearables, and other electronic devices, to make Immersion haptic patent licenses available to mobile phone, wearable, and PC OEMs through Dongwoon.
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CMNDF | Hot Stocks09:08 EST Clearmind completes IND-enabling studies for CMND-100 - Clearmind Medicine announced it has completed IND-enabling studies on its CMND-100 compound aimed at treating alcohol use disorder, in preparation for its first in-human clinical trial. An Investigational New Drug application is required by the U.S. Food and Drug Administration before commencing clinical studies in humans may initiate.The company is in the process of preparing the IND for its submission to the FDA and the Israeli Ministry of Health. As part of this year-long process, the company preformed pharmacology, pharmacokinetics, and toxicology assessments on the MEAI-based compound. Previous pre-clinical studies using MEAI demonstrated a high safety profile and indications of a significant dose-dependent effect reducing alcohol consumption in treated animals. CMND-100, which is Clearmind's lead compound, is a novel psychedelic-derived drug candidate, exhibiting compelling evidence that suggests a significant reduction of desire to consume alcoholic beverages- addressing a global unmet need.
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CFLT | Hot Stocks09:06 EST Confluent appoints Shaun Clowes as chief product officer - Confluent announced the appointment of Shaun Clowes as chief product officer, or CPO. As chief product officer, Clowes will lead the strategy and execution of all product-related activities within Confluent, including product innovation and the product roadmap. Clowes joins Confluent from Mulesoft, where he served as CPO, and before that, Atlassian where he served as the head of growth.
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NOGN SHOP | Hot Stocks09:06 EST Nogin names Bonham-Carter as Chief Revenue Officer - Nogin (NOGN) announced that it has named Rupert Bonham-Carter as Chief Revenue Officer. Bonham-Carter will lead Nogin's go-to-market operations, driving sales and developing strategic relationships to accelerate the company's growth. Bonham-Carter was most recently the director of global sales and partnerships at Shopify (SHOP), where he headed up global sales teams, led global business development, built Shopify's first sales development and systems integrator teams, and unified Shopify's agency programs.
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AI | Hot Stocks09:05 EST C3.ai gets 1st three orders in five year $500M pact with U.S. MDA - C3 AI has received the first three orders in its five-year, $500M Production-Other Transaction Agreement sponsored by the U.S. Missile Defense Agency or MDA, which will be applicable across the Department of Defense . All three orders will leverage the C3 AI Platform to accelerate deployment of critical enterprise artificial intelligence capabilities across the MDA. "An enterprise AI platform that allows for credible assessment of combined kinetic and non-kinetic effects across domains is critical to optimize and correctly evaluate missile defense mission effectiveness," said Ed Abbo, C3 AI President and CTO. "We are thrilled to fulfill the MDA's first three orders in our five-year partnership." "The insights extracted from large volumes of sensor, network, and weapon system test data are critical to analyzing the operational effectiveness, suitability, and survivability of the Missile Defense System," said Dr. Shari Feth, MDA Innovation Science and Technology Director. "The deployment of an enterprise AI platform has allowed MDA to demonstrate robust end-to-end capabilities for collaborating on AI model development and rapidly deploying insights into new production applications."
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HDSN | Hot Stocks09:05 EST Hudson's partner transitions to exclusive use of reclaimed refrigerants - Hudson Technologies announced that its partner AprilAire has fully transitioned to the exclusive use of reclaimed refrigerants in its refrigeration systems. Earlier this year, the two companies announced their collaboration in support of healthy air initiatives, with AprilAire committing to being an early adopter for the incorporation of reclaimed refrigerant into its products and teaming with Hudson as its exclusive supplier of reclaimed refrigerants. Brian Coleman, President and Chief Executive Officer of Hudson Technologies commented, "With our industry-leading reclamation technology and long-standing commitment to responsible, sustainable refrigerant management, we're delighted to work with AprilAire and other industry partners, as they make the shift to creating more environmentally friendly products that operate using reclaimed refrigerant. We applaud AprilAire for its advanced and aggressive transition to the use of 100% reclaimed refrigerant in its products as an early adopter of the CARB Regulation Order for Certified Reclaimed Refrigerant Use Requirements. CARB calls for the use of at least 10% reclaimed refrigerant in equipment coming off the factory floor, and AprilAire is an industry forerunner with its evolution to exclusively incorporating reclaimed refrigerant into its products. We believe our partnership, with its focus on recovering, reclaiming and reusing refrigerants, not only reduces waste and air pollution, but also maximizes the economic value of refrigerants."
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AI | Hot Stocks09:04 EST C3.ai receives first three orders in five-year, $500M MDA agreement - C3 AI has received the first three orders in its five-year, $500M Production-Other Transaction Agreement sponsored by the U.S. Missile Defense Agency, or MDA, which will be applicable across the Department of Defense, or DoD. All three orders will leverage the C3 AI Platform to accelerate deployment of critical enterprise artificial intelligence capabilities across the MDA.
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TBLA | Hot Stocks09:03 EST Taboola signs exclusive, multi-year deal with Time Out - Taboola announced a new multi-year deal with Time Out, a global media and hospitality business that inspires and enables people to discover and experience the best things to do, see and eat in 333 cities in 59 countries. Taboola will be implemented across all Time Out websites globally, including the U.S., U.K, France, Spain, Portugal, Singapore and Australia. Under the agreement, Taboola will be featured on Time Out websites across articles, venues and landing pages. Time Out will also leverage Taboola Feed, a seamlessly integrated feed that provides readers with personalized content for a more engaging experience and video. Additionally, Time Out will incorporate Taboola Newsroom, a technology offering that uses advanced A.I. and readership signals from millions of daily active users.
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DTGI | Hot Stocks09:02 EST Digerati Technologies' NextLevel Internet launches CCaaS solution - Digerati Technologies announced the roll-out of a new Contact Center as a Service solution. This new Omni-Channel CCaaS offering, which will initially be available through Digerati's subsidiary NextLevel Internet, will enhance the portfolio of solutions the Company is currently offering to the SMB marketplace. NextLevel's new intelligent Contact Center suite of services uses a combination of artificial intelligence, workflow automation, virtual agents, intelligent call routing, integrations, reporting, and employee collaboration tools to help businesses reduce costs and improve the customer experience, all without the need to add additional resources. As a cloud-based solution, NextLevel's Contact Center allows its business users to deliver superior customer care from anywhere.
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FEAM | Hot Stocks09:02 EST 5E Advanced Metals signs LOI with Estes Energetics - 5E Advanced Materials has entered into a non-binding letter of intent, LOI, with Estes Energetics to collaborate in producing boron advanced materials for solid rocket motors to support the U.S. space and military industries. Under the terms of the LOI, 5E and Estes will work towards a binding agreement for the supply of boron advanced materials, which are used in the manufacture of solid rocket motor ignitors. 5E and Estes Energetics will also consider a broader collaboration focused on partnering on production facilities, business development activities and sharing technical know-how for the purpose of developing boron advanced materials and proprietary intellectual property targeting space and military applications. The boron advanced materials used by Estes Energetics and under the terms of the LOI, align with recent U.S. government initiatives and programs as they are critical in military munitions and civilian applications and are subject to supply risk given overseas supply concentration and U.S. reliance on imports. Commenting on the LOI with 5E, Karl Kulling, Estes Chief Executive Officer noted: "There is a growing awareness of supply chain risk in the US. By collaborating with 5E, we are building a supply chain that starts from a domestic mine and continues all the way through products broadly used in solid rocket motors, pyrotechnics, and other applications. Boron advanced materials complement our existing manufacturing and research efforts in critical chemicals and solid rocket motors. Boron is used in mature products and has great promise in high-performance fuels."
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PCRFY LCID | Hot Stocks09:02 EST Panasonic Energy, Lucid Group announce battery supply agreement - Panasonic Energy Co., a Panasonic Group (PCRFY) company, and Lucid Group (LCID) announced they have entered into multi-year agreements to supply batteries for Lucid's award-winning luxury electric vehicle, Lucid Air, the fastest-charging, longest range EV on the market, and Lucid's upcoming Gravity SUV. The agreement marks another milestone in Panasonic's plans to expand production of lithium-ion EV batteries beyond Japan and into the U.S. with production coming from both a facility in Japan, as well as expected future production from its recently announced battery production facility in De Soto, Kansas.
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RICK | Hot Stocks09:02 EST RCI Hospitality to acquire five adult nightclubs in Texas for $66.5M - RCI Hospitality signed definitive agreements to acquire two Baby Dolls and three Chicas Locas adult nightclubs and their associated real estate in the Dallas-Fort Worth and Houston markets. The acquisition would be RCI's second largest since its founding. Consideration to be paid for all transactions totals $66.5M, consisting of $25.0M in total cash; 10-year, 7% seller financing notes totaling $25.5M; and 200,000 restricted shares of common stock based on a per share price of $80, subject to a lock-up, leak out agreement. EBITDA contribution of approximately $11M is expected in the first year. Four locations are open, a fifth will reopen shortly after a full remodel, and RCI anticipates expanding operations of two of the locations. Once the remodeling and expansions are complete, EBITDA is expected to grow to $14-16M annually. Closing, which is expected in January, is subject to transfer of and/or obtaining all necessary permits, licenses, and other authorizations; and other customary closing conditions for transactions of this kind.
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ITRI | Hot Stocks08:57 EST Itron signs contract with GRU to modernize infrastructure - Itron announced that they signed a contract with Gainesville Regional Utilities, or GRU, a multi-service utility owned by the City of Gainesville, to modernize the utility's infrastructure with Itron's multi-purpose industrial IoT, or IIoT, network solution, including smart Gen 5 500W water and Gen 5 500G gas communication modules and Gen5 Riva Distributed Intelligence enabled electric smart meters. The utility will also take advantage of Itron Enterprise Edition Meter Data Management as a Software-as-a-Service to manage meter and sensor data. These solutions will allow GRU to improve operational efficiency, data collection accuracy and enhance customer service. The utility plans to deploy Itron's solutions across Gainesville and surrounding areas.
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AZ | Hot Stocks08:56 EST A2Z announces increased smart cart order from Yochananof - A2Z Smart Technologies announces that it has received an increased purchased order of 30% from a leading grocery chain M. YOCHANANOF AND SONS. This now brings the total order to 1,300 smart carts and total aggregate revenues to approximately New Israeli Shekels 35M. Pricing and delivery terms are in line with the original agreement and payment will be made in advance for each batch of smart carts delivered. To date, Yochananof has paid the Company approximately NIS 20M. Delivery of the initial purchase order continues at pace with 11 Yochananof stores now utilizing the Cust2Mate Smart Cart solution. The Company anticipates completion of the initial purchase order and the increased purchased order by the end of the second quarter of 2023.
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PAX | Hot Stocks08:55 EST Patria Investments announces divestment of ODATA, Entrevias - Patria Investments announced definitive agreements for the divestments of ODATA, a Brazilian data center service provider, and Entrevias, a toll road operator in the state of Sao Paulo. Together these transactions are expected to generate approximately $1.4 billion in proceeds for investors in Patria's Infrastructure Fund III. ODATA is a data center service provider offering scalable, reliable and flexible IT infrastructure. It is among the fastest growing hyperscale data center platforms in the Latin America, with operational facilities strategically located across Brazil, Colombia, Mexico and Chile, as well as additional data centers currently under development across the region. Aligned Data Centers, a leading technology infrastructure company offering innovative, sustainable and adaptive Scale Data Centers and Build-to-Scale solutions for global hyperscale and enterprise customers, has entered into a definitive agreement to acquire ODATA from Patria Infrastructure Fund III and other selling stakeholders, marking its expansion into Latin America. On December 1, 2022, Patria also announced the divestment of 55% of its stake in Entrevias Concessionaria de Rodovias to VINCI, a world leader in concessions, energy and construction. Entrevias was created by Patria in 2017, and operates a 30-year concession encompassing 570 kilometers of toll roads that cross the state of Sao Paulo. The concession entailed significant capex investment by Patria to restore, enlarge and implement new technologies throughout the existing highway to improve the transportation matrix for both passengers and cargo, and foster the connection and development of surrounding regional economic centers. Patria's Infrastructure Fund III will continue to own the remaining 45% of Entrevias. The divestment of ODATA and Entrevias will bring cumulative distributions to fund investors to approximately $2 billion, surpassing a full return of capital, and bringing the fund near to the performance hurdle threshold, beyond which it enters the "100% catch up" phase and can begin realizing the accrued performance fees.
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JUPW | Hot Stocks08:53 EST Jupiter Wellness announces approval to dual list on Upstream - Jupiter Wellness announced its approval to dual list its shares on Upstream, the trading app for digital securities and NFTs powered by Horizon Fintex and MERJ Exchange Limited. Trading begins on Upstream January 10, 2023, at 10:00 am ET under the ticker symbol JUPW. Global investors can get ready to trade by creating an account on Upstream and completing a simple KYC identity verification
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BRSH | Hot Stocks08:52 EST Bruush electric toothbrush to be featured item on home shopping channel TSC - Bruush Oral Care will be participating in a one-day sales campaign on the home shopping channel, Today's Shopping Choice, on Friday December 16, 2022. This will be the Company's second appearance on the home shopping channel, with their first appearance having taken place in September. TSC is Canada's only nationally televised shop-from-home service, reaching into over 7 million households across the country and is actively watched by almost 1.5 million viewers weekly. Through the campaign with TSC, Bruush hopes to reach a broader audience this holiday season and will showcase its most popular colors while on the air. Earlier this month, the Company launched two seasonal colors - Arctic Blue and Midnight Blue - which will be available on a limited-edition basis through the holiday period.
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UAVS | Hot Stocks08:51 EST Ageagle Aerial Systems introduces eBee VISION drone - AgEagle Aerial Systems announced its introduction of the new eBee VISION, a small, fixed-wing unmanned aerial system designed to provide real-time, enhanced situational awareness for critical Intelligence, Surveillance and Reconnaissance missions. Scheduled for global commercial release in 2023, the eBee VISION delivers high resolution, medium-range video imagery made possible by its 32x zoom and powerful thermal observation capabilities. Its sensor payloads are capable of detecting, tracking and geo-locating objects in both day and night conditions. Offering up to 90 minutes of flight time and the same ease-of-use that has earned AgEagle's eBee line of drones industry distinction, the eBee VISION can be deployed and operated by a single person.
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AMAO | Hot Stocks08:50 EST American Acquisition target Royalty Management becomes CASFER member - American Acquisition Opportunity merger target company, Royalty Management Corporation announced that it has become a gold member of Texas Tech University's recently created Center for Advancing Sustainable and Distributed Fertilizer Production, or 'CASFER' organization. Becoming a gold members of CASFER enables RMC to have access to the technologies and intellectual property developed out of CASFER, in particular the innovative and novel technologies to produce, capture, and recycle nitrogen-based fertilizers resulting from farming activities.
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BKTI | Hot Stocks08:49 EST BK Technologies receives $1.4M purchase order from Washington State DNR - BK Technologies Corporation received a purchase order valued at $1.4M from the Washington State Department of Natural Resources for its BKR 5000 portable communications technology and accessories. This is the first significant purchase of the BKR 5000 by the DNR following a smaller order placed in March of 2022 for testing and approval purposes.
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NCRA | Hot Stocks08:47 EST Nocera reports $3.2M in eel sales revenue in November - Nocera announced that it has hit a record-breaking revenue for the month of November, reaching approximately $3.2M in eel sales revenue.
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YUM | Hot Stocks08:44 EST Yum! Brands sees long-term annual unit growth 5%, annual system sales growth 7% - Sees at least 8% annual operating profit growth long-term. Comments taken from Yum!'s investor day event.
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POAI | Hot Stocks08:44 EST Predictive Oncology announces appointment of Malandro to SAB - Predictive Oncology announced the appointment of Marc Malandro, Ph.D., to the company's Scientific Advisory Board, SAB, where he will serve alongside other key thought leaders in their respective fields to guide the company's scientific initiatives and growth strategy. Dr. Malandro currently serves as the Vice President of Operations for Science at the Chan Zuckerberg Initiative, where he is part of the team that partners, supports and builds novel advances and tools to enable and accelerate biomedical research.
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MOB | Hot Stocks08:44 EST Mobilicom secures $100,000 inital order from tier-1 customer - Mobilicom announced the Company has secured a major design win and initial purchase order of over $100,000 from a new customer, a very large Tier-1 Asia-based small-sized drone manufacturer.
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KULR MSFT | Hot Stocks08:43 EST KULR's CellCheck Battery Monitoring System launches on Microsoft's Azure - KULR Technology Group (KULR) announced that its CellCheck Battery Monitoring System is now running on the Azure Cloud Computing Service by Microsoft ( MSFT). This next-generation battery safety technology captures real-time and lifetime battery data allowing it to detect adverse electrical, environmental and physical events resulting in maximum battery safety, reliability, and performance. In its new iteration, CellCheck devices can wirelessly transmit live sensor data from the edge to the Azure Cloud where it is displayed on an extensive dashboard system. "Electrifying the circular economy will generate vast streams of high-value data," said Keith Cochran, President and COO of KULR Technology Group. "We are developing cutting-edge solutions that enable our customers to realize the full value of this data - from using predictive analytics for preventing thermal runaway, to using battery intelligence data for enhancement of operational performance, to using sustainability data to visualize ESG and climate impact. CellCheck technology will dramatically increase the safety of battery packs by providing instant analysis of current and historic health. We believe this to be a game-changing product for the $44 billion lithium-ion battery market."
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BKTI | Hot Stocks08:42 EST BK Technologies gets $1.4M purchase order from the Washington State DNR - BK Technologies announced that it has received a purchase order valued at $1.4M from the Washington State Department of Natural Resources or DNR for its BKR 5000 portable communications technology and accessories. This is the first significant purchase of the BKR 5000 by the DNR following a smaller order placed in March of 2022 for testing and approval purposes.John Suzuki, CEO of BK Technologies, commented, "We are pleased that the Washington State Department of Natural Resources has selected the BKR 5000 radio for use in their field operations. The agency has been one of the largest users of BK radios at the state level. The BKR 5000 will provide portable communications technology that is ideally suited for their diverse field operations, and we look forward to continuing this longstanding partnership with the DNR and supporting them in their management and conservation responsibilities."
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CFRX | Hot Stocks08:42 EST ContraFect announces pricing of $7M registered directoffering - ContraFect Corporation entered into a securities purchase agreement with a single institutional investor to purchase approximately $7.0 million of its common stock in a registered direct offering and warrants to purchase common stock in a concurrent private placement. The combined effective purchase price for each share of common stock and associated warrants will be $0.129. nder the terms of the securities purchase agreement, ContraFect has agreed to issue 4,350,000 shares of common stock and pre-funded warrants to purchase 49,913,565 shares of common stock. In the concurrent private placement, which will be consummated concurrently with the offering, ContraFect also has agreed to issue Class A warrants to purchase up to an aggregate of 108,527,130 shares of common stock and Class B warrants to purchase up to an aggregate of 54,263,565 shares of common stock. Each of the warrants is subject to a customary beneficial ownership limitation on exercisability, and the Class A warrants and Class B warrants will not be exercisable at all until ContraFect obtains a shareholder approval of an amendment to the Company's certificate of incorporation for either an increase in authorized shares of its common stock or a reverse split of its common stock and a shareholder approval as required under the Nasdaq rules with respect to this transaction. Each of the Class A warrants and Class B warrants will have an exercise price of $0.129 per share of common stock. The Class A Warrants will expire five years from the date on which they become exercisable. The Class B warrants will expire six months from the date on which they become exercisable. Maxim Group LLC is acting as the sole placement agent for the offering. The offering is expected to close on or about December 15, 2022, subject to the satisfaction of customary closing conditions.
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HUDI | Hot Stocks08:41 EST Huadi named Chief Executive Entity of Wenzhou the Belt, Road association - Huadi International announced the Company has been named as the Chief Executive Entity of Wenzhou the Belt and Road Enterprise Development Association. HUDI's director Jueqin Wang was also appointed as an executive president of the Association for a five-year term. Di Wang, Chairman of Huadi International Group, commented: "Belt and Road Enterprise Development Association is a professional service platform with flagship significance in the province. We are honored to be chosen to serve as the Chief Executive Entity for the Association, and will make persistent efforts to actively promote multilateral cooperation on trade and investment in Wenzhou among our member enterprises and beyond. We believe that the Association will be a medium for extensive exposure to international capital markets, which shall help HUDI explore and develop new business opportunities for future sustainable growth."
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RVYL | Hot Stocks08:41 EST RYVYL Inc. says 'no exposure to crypto firms' that filed for bankruptcy - RYVYL announced a letter to shareholders regarding recent events in the cryptocurrency market and the implications on RYVYL, which read in part, "It's been a tumultuous end to 2022 for the cryptocurrency marketplace with the fall of FTX and BlockFi among other firms, along with the sharp decline in the price of cryptocurrencies and related securities. In the wake of this crises, we at RYVYL now more than ever want to clearly communicate the conviction that we have in our differentiated suite of payment technology solutions that arm us to seize on a fantastic opportunity and emerge as a leader in the digital payments space. RYVYL is not a cryptocurrency firm and has no exposure to crypto firms that have recently filed for bankruptcy protection. The collapse of crypto exchanges only strengthens our position and validates the strategy we have taken. Our smart contract token, known as coyni, has a unique architecture as a USD-pegged stablecoin, backed dollar for dollar in a federally insured custodial account with near real-time attestation, ensuring the continuous health and compliance of the ecosystem. Our technology settles through a proprietary blockchain ledger that we believe is the ideal digital payments product on the market today. To clarify, each coyni digital token is held in a wallet on the platform and matched with one U.S. dollar held in a custodial account by a federally insured financial institution. The dollars backing coyni are not tied up in investments or US treasury notes and are not converted to cryptocurrencies. All industry failures we have seen recently, in both stablecoin and crypto, occurred with ecosystems that did not utilize these safety measures, leading to severe market disruption. We continue to support regulatory oversight along these principles. One of the most significant points of distinction for us is that coyni has near real-time custodial account attestation. This was no small feat and accomplished only after a lengthy review of IT, compliance and, specifically, SOC 2 compliance certification from Armanino, a top accounting, consulting and technology firm in the U.S. The recent crypto market collapse will undoubtedly lead to increased regulatory oversight, something which we welcome and believe will be beneficial to our business and growth trajectory. As oversight increases and stablecoin matures, we believe there will be less need for volatile cryptocurrencies. We believe a stablecoin that is properly pegged to fiat currency, both in coverage and compliance reporting, is equivalent to fiat and is likely to eventually be even better than fiat as it has the potential of being adjusted or hedged by commodity. This is where RYVYL can step in. While some large banks work with the Federal Reserve on a recently announced pilot-program leveraging blockchain backed stablecoin technology, we are already in the market as demonstrated by our successful work in American Samoa. With a closed-loop payment system already in operation, we bring to market our leading-edge digital payment solutions across the banking sector and in multiple countries to quickly achieve scale and market share. While market conditions have made for a challenging year for stocks in our sector and presented obstacles to our acquisition strategy, we believe the latest fallout in the crypto landscape provides all the opportunity we need to become a disruptive force in the digital payments market and deliver sustainable long-term growth for our shareholders."
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ALDX | Hot Stocks08:40 EST Aldeyra: Drug candidate ADX-629 trial improved signs of intoxication in Alcohol - Aldeyra Therapeutics announced demonstration of target engagement and improvement in the signs of alcohol intoxication in a sequence-randomized, double-masked, placebo-controlled crossover Phase 2 clinical trial of ADX-629, a first-in-class orally administered investigational new drug candidate. Relative to placebo, ADX-629 reduced dermal flushing , increased Romberg test balance time , and lowered levels of the ethanol RASP metabolite acetaldehyde following acute exposure to alcohol. "The evidence of activity of ADX-629 following acute alcohol intoxication is encouraging given the paucity of treatment options for patients with alcohol-associated liver diseases," stated Loretta L. Jophlin, M.D., Ph.D., Assistant Professor of Medicine at the University of Louisville. "For patients with moderate alcohol-associated hepatitis, standard of care is generally observation, and thus there is demand for potential new therapies such as ADX-629 that could prevent disease progression or otherwise improve outcomes." " "With unparalleled expertise in the discovery and development of drug product candidates that target RASP, we remain committed to bringing to market a novel pharmacology to address unmet medical need." Based on the results of the alcohol challenge clinical trial, Aldeyra plans to support an investigator-sponsored Phase 2 clinical trial of ADX-629 in moderate alcoholic hepatitis. The trial is expected to be initiated in 2023. Results from a Phase 2 clinical trial of ADX-629 in chronic cough are expected in the first half of 2023, and results from Phase 2 clinical trials of ADX-629 in minimal change disease and Sjogren-Larsson Syndrome are expected in 2023.
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SLS | Hot Stocks08:39 EST Sellas Life Sciences announces Phase 1 data with GFH009 - SELLAS Life Sciences Group announced positive results from its ongoing dose escalating Phase 1 first-in-human study of its highly selective CDK9 inhibitor, GFH009, in patients with relapsed and/or refractory hematologic malignancies. Results include preliminary safety and efficacy data presented this week at the American Society of Hematology, ASH, Annual Meeting, along with updated data since the ASH abstract cutoff date of August 2, 2022. One patient treated with GFH009, in the 30 mg once per week cohort, achieved a confirmed complete response, which is the first CR reported in acute myeloid leukemia with any CDK9 inhibitor monotherapy. No minimal residual disease was detected in this CR patient and full neutrophil, platelet and red blood cell recovery was reported. Anti-cancer effects were also observed at multiple dose levels in both the r/r AML and r/r lymphoma treatment groups. Neutrophil counts improved in most patients from both groups while on treatment, and drug-related severe neutropenias were observed in less than 10% of enrolled patients. Dose limiting toxicities have not been identified at any of the levels studied to date and the maximum tolerated dose has not yet been reached. A total of 57 patients have been enrolled to date, including 31 with r/r lymphoma and 26 with r/r AML. All enrolled patients to date were heavily pretreated with up to six lines of previous therapy. New dosing regimens added to the ongoing trial include 40 mg administered twice per week and 30 mg, 45 mg and 60 mg administered once a week, all of which have been fully enrolled except for the 60 mg cohort. All initially planned dose escalation cohorts with 2.5 mg, 4.5 mg, 9 mg, 15 mg, 22.5 mg and 30 mg of GFH009 administered twice per week are also fully enrolled. The 45 mg once a week cohort, although fully enrolled, has not yet been analyzed. Selective Preliminary GFH009 Monotherapy Efficacy Data in r/r AML Group: One patient has a confirmed CR and is MRD negative after failing azacytidine-venetoclax regimen; One patient continued on treatment for 3 months; Two patients had blast count decreases of greater than or equal to50% in bone marrow. Selective Preliminary GFH009 Monotherapy Efficacy Data in r/r Lymphoma Group: 2 patients had partial response; 4 patients achieved SD with one of them maintaining SD for over a year while still continuing GFH009 monotherapy; The pharmacokinetics profile of GFH009 shows dose proportional concentrations with a biphasic profile of rapid initial tissue distribution followed by slower elimination from tissues. There were no apparent time-dependent changes in volume of distribution or clearance.
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CCK | Hot Stocks08:39 EST Crown Holdings appoints two new directors to Board from Icahn Enterprises - Crown Holdings has entered into an agreement with Icahn Enterprises whereby Jesse Lynn and Andrew Teno, General Counsel of Icahn Enterprises and Portfolio Manager of Icahn Capital, respectively, will join the company's Board of Directors, effective immediately. Lynn and Teno will also stand for election at the company's upcoming 2023 Annual Meeting of Shareholders and Crown has agreed to include Teno and Lynn on its recommended slate of nominees for election at the company's 2023 AGM. With the additions of Lynn and Teno, the Crown Board will expand to 13 directors, 12 of whom are independent. Pursuant to the Director Appointment and Nomination Agreement, Icahn Enterprises, which owns 8.5% percent of Crown's outstanding common stock, has agreed to customary standstill, voting commitments and other provisions. Jesse Lynn has been general counsel of Icahn Enterprises since 2014. From 2004 to 2014, Lynn was Assistant General Counsel of Icahn Enterprises. Lynn has been a director of Xerox since November 2021; FirstEnergy since March 2021; and Conduent since April 2019. Andrew Teno has been a portfolio manager of Icahn Capital LP, the investment management subsidiary of Icahn Enterprises, since October 2020. Teno has been a director of Southwest Gas since May 2022; FirstEnergy since March 2021; and Herc Holdings since February 2021.
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BIOYF | Hot Stocks08:37 EST Biosyent announces renewal of normal course issuer bid - BioSyent announced that the TSX Venture Exchange has accepted the Company's Notice of Intention to Make a Normal Course Issuer Bid. Pursuant to the NCIB, BioSyent may purchase up to 690,000 of its common shares over a 12-month period, representing approximately 5.70% of the Shares outstanding as of December 13, 2022. The NCIB will commence on December 19, 2022 and terminate on December 18, 2023, or such earlier date on which purchases under the NCIB have been completed. Purchases of Shares under the NCIB will be made through the facilities of the TSX-V or alternative Canadian trading systems at the market price of the Shares at the time of acquisition. The number of Shares the Company is permitted to purchase during any 30-day period is limited to 241,957 Shares, representing 2% of the total outstanding Shares. BioSyent has entered into an automatic share purchase plan with a broker, Raymond James Ltd., in connection with the NCIB to allow for the purchase of Shares during certain pre-determined blackout periods. Outside of these pre-determined blackout periods, Shares will be purchased at the discretion of senior management of BioSyent. BioSyent believes that the Shares may from time to time trade in a price range that does not adequately reflect the value of the Shares in relation to its activities and future prospects. As a result, BioSyent believes that the purchase of Shares, from time to time, would be an appropriate use of corporate funds in light of potential benefits to remaining shareholders. BioSyent has repurchased and cancelled a total of 2,200,625 Shares under NCIBs between December 10, 2018 and December 12, 2022.
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IGIFF... | Hot Stocks08:36 EST nesto raises $80M Series C financing round - nesto announced the closing of an oversubscribed $80 million Series C financing. The financing round was led by IGM Financial (IGIFF), with support from existing and new investors; Diagram Ventures, Portage, NAventures, National Bank of Canada's corporate venture capital arm (NTIOF), BMO Capital Partners (BMO), as well as Michael Rowell and Michael Paulus. The Series C financing round will enable nesto to further develop its proprietary technology, expand its marketing capabilities across Canada and launch nesto Mortgage Cloud. nesto intends to offer the nesto Mortgage Cloud to financial institutions in order to support their ongoing digital transformation, search for efficiency and their continuing efforts to modernize their mortgage operations with best-in-class technology for an effortless customer experience. By doing so, nesto will diversify its customer base and revenue streams, and strengthen its position as the leader in digital mortgage lending.
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ADEA | Hot Stocks08:36 EST Adeia renews multi-year IP license agreement with SONIFI - Adeia announced that it has renewed a multi-year agreement with SONIFI Solutions to license Adeia's media intellectual property portfolio. SONIFI has served the hospitality industry for over 30 years, offering technology solutions that enhance the engagement, entertainment and digital experience of hotel and resort guests. "SONIFI is addressing the evolving needs of the hospitality industry as the world emerges from travel restrictions imposed by a global pandemic that had constrained business and leisure travel. We are excited about the relationship Adeia is building with one of the leading technology providers to a sector that is of critical importance to the global economy," said Dr. Mark Kokes, Adeia's chief licensing officer and general manager, media. "Our license agreement with SONIFI further confirms the value and longevity of Adeia's media IP portfolio for organizations serving the traveling public's needs and we are excited to both expand and extend our relationship with them."
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GNSS | Hot Stocks08:34 EST Genasys announces new Zonehaven, Genasys emergency management contract - Genasys announced a multi-year Genasys Emergency Management and Zonehaven software-as-a-service contract with Monterey County, California. GEM is displacing a competitor's critical event management system. "Monterey County's diverse coastline and rugged mountains, which include the steepest coastal slope in the contiguous United States, present formidable emergency management challenges," said Richard Danforth, Chief Executive Officer, Genasys, Inc. "The county's major disasters over the last 50 years include severe coastal storms, flooding, landslides, earthquakes, and several large wildfires. To better protect the county's 430,000 residents and more than 3 million annual visitors during disasters and other crisis situations, Monterey County emergency management personnel and first responders are deploying Genasys critical communications software and evacuation resources," continued Mr. Danforth. "10 of California's 15 coastal counties have implemented our unified multichannel platform for county emergency management. In two additional coastal counties, San Francisco and Orange, certain cities and tourist areas are covered by Genasys public safety solutions."
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QNRX | Hot Stocks08:33 EST Quoin announces dosing of first patient in trial in Netherton Syndrome - Quoin Pharmaceuticals announces that the first patient has been dosed in its ongoing clinical trial evaluating the safety and efficacy of QRX003 as a treatment for Netherton Syndrome. Quoin's first clinical trial is a randomized, double blinded, vehicle-controlled study which is being conducted under a U.S. Investigational New Drug, IND, Application and is assessing two different doses of QRX003 topical lotion versus a vehicle lotion in Netherton patients. The test materials are applied once daily over a twelve-week period, to pre-designated areas of the patient's body. Based on discussions with the U.S. Food and Drug Administration, FDA, a number of different clinical endpoints will be assessed in the study. In October 2022, Quoin announced it plans to initiate a second study assessing its QRX003 topical lotion in Netherton patients who are currently receiving off-label treatment including systemic therapy for symptomatic relief. This second study, which has now been cleared by the FDA to initiate clinical testing, is an open-label, non-placebo controlled trial that will evaluate 10 Netherton patients over a twelve week period. The study, which will run concurrently with Quoin's ongoing clinical trial, will be conducted at the same sites and by the same clinical investigators as the first study, thereby optimizing the potential for a rapid recruitment of patients. Quoin CEO, Dr. Michael Myers, said, "With over seventy potential candidates already having gone through our initial screening process, we have been delighted with the level of interest in our clinical programs that has been shown by the Netherton community. The dosing of our first patient and the clearance of our second study are big steps forward for Quoin and, hopefully, for the community in general. With all six clinical sites on track to be fully opened this month, we are hopeful that the rate of recruitment into both studies will accelerate rapidly going forward.
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CANN | Hot Stocks08:30 EST Trees Corporation closes Green Tree acquisition - TREES CORPORATION announced the closing of the transaction to acquire the Green Tree cannabis dispensaries, located in Berthoud and Longmont, Colorado, along with additional cultivation and manufacturing assets. This purchase continues the rapid and targeted expansion of TREES' dispensary footprint and supports our ongoing retail expansion plan in Colorado. Allyson Feiler, the founder of Green Tree, was elected to serve on our Board of Directors as well as our Nominating Committee, on December 12, 2022. The Company continues to evaluate merger and acquisition transactions that fit both financially and strategically into our geographic expansion plans.
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HUMA | Hot Stocks08:27 EST Humacyte hosts KOL webinar on vascular trauma - Humacyte announced that it will host a key opinion leader webinar on its proprietary Human Acellular Vessels in the treatment of wartime vascular trauma on Thursday, December 15, 2022 at 8:00 AM ET. The event will feature presentations from several Ukrainian surgeons discussing use of the HAV to treat multiple cases of war induced traumatic injuries. The HAV has received priority designation for the treatment of vascular trauma from the U.S. Secretary of Defense. The HAV is highly resistant to infection and is designed to offer off-the-shelf availability for the repair of injured blood vessels. The HAV is made in a bioreactor bag that can be shipped and stored, so that the HAV can be immediately available when needed to repair vascular injuries. The HAV is designed to address long-standing limitations of vascular tissue repair and replacement in acute injuries, both in civilian and combat settings. The HAV results included in these presentations are part of Humacyte's humanitarian relief initiative in Ukraine. In June 2022, Humacyte provided investigational HAVs to multiple front-line Ukrainian hospitals for the treatment of patients with traumatic vascular injuries sustained during the conflict. In the United States, Humacyte is also evaluating the HAV for treatment of civilian vascular trauma in a Phase 2/3 clinical trial. Patients enrolled in the Phase 2/3 trial have no suitable autologous vein for reconstruction of their traumatic injuries, and many have contaminated wounds that make synthetic conduits not amenable for use. The HAV is an investigational product and has not been approved for sale by the FDA, the Ukrainian Ministry of Health, or any international regulatory agency.
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PCRX | Hot Stocks08:26 EST Pacira reports preliminary net product sales of $57.5M for November - Pacira BioSciences reported preliminary unaudited net product sales of $57.5 million for the month of November 2022. The company's net product sales include EXPAREL, ZILRETTA, and the iovera degrees system. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc. "As many of our large hospital customers are facing unprecedented financial challenges, we have rolled out a number of new programs to make EXPAREL more readily available to a broader range of potential new patients. Key programs include an expanded contracting strategy offering single-digit discounting to many of our large hospital customers and the implementation of 340B pricing, which opens up access to 5,200 new accounts. In addition, our collaboration with Sevredent is providing access to more than 1,800 oral and maxillofacial surgery facilities, allowing us to build a new customer base within this surgical specialty," said Dave Stack, CEO. "With expanding manufacturing capacity and improving gross margins, we have an incentive to sell every EXPAREL unit we can manufacture. These programs are a win-win that should significantly drive EXPAREL volume growth and more than offset the single-digit impact to our net selling price. We expect these programs to be accretive to net revenues in 2023 and beyond as we access a much larger customer base representing thousands of new patients. Most importantly, these programs allow more patients to benefit from EXPAREL and advances our mission to provide a non-opioid pain management solution to as many patients as possible."
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HSC | Hot Stocks08:24 EST Harsco announces Tosyali Harsco signs 10-year contract with Tosyali Holding - Harsco Corporation announced that Tosyali Harsco, Harsco's joint venture with Tosyali Holding, Turkey's leading flat steel and steel pipe producer, signed a 10-year contract with an estimated revenue of $210M USD to provide services at the company's green field steel plant in Sariseki, Iskenderun. Initial plant commissioning is set to begin at the new green field steel plant in Sariseki, in March 2023. The plant is a significant investment of nearly $2.5 billion USD value for Tosyali and will include a total 4 million ton capacity, two Quantum electric arc furnaces, slab and billet casting machines, a hot rolling mill, and long and flat product finishing lines. Tosyali Harsco's scope of work at the new Sariseki plant will include the treatment of all scraps via sorting, shearing, lancing and cleaning processes, scrap handling and logistics to the melt shop, underfurnace cleaning, ladle slag handling and slag processing. "I would like to congratulate our team for the outstanding performance that made this win possible," said Harsco Environmental Chief Operating Officer Russ Mitchell. "This expanded relationship is a testament to Tosyali's confidence in our ability to deliver services that advance both their business and environmental goals."
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WVE | Hot Stocks08:24 EST Wave Life Sciences jumps 12% to $4.05 after strategic collaboration with GSK
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SLRX | Hot Stocks08:23 EST Salarius Pharmaceuticals presents clinical data on seclidemstat - Salarius Pharmaceuticals announced that investigators in the Department of Leukemia at the University of Texas MD Anderson Cancer Center presented clinical data on seclidemstat in patients with MDS and CMML at the 64th American Society of Hematology, ASH, Annual Meeting and Exposition underway in New Orleans and virtually. Seclidemstat is a novel oral, reversible, targeted LSD1 inhibitor. The objective of this investigator-initiated Phase 1/2 dose-escalation study is to evaluate the safety, tolerability, maximum tolerated dose and overall response of seclidemstat in combination with azacitidine in adult patients with higher-risk MDS or CMML who previously failed or relapsed after hypomethylating agent therapy. As of October 2022, nine patients were enrolled with a median follow-up time of 3.9 months. Typically, overall survival is four to six months for patients after failing therapy with hypomethylating agents. As presented at ASH, no serious adverse events were reported and all adverse events observed in the study were manageable. Of the eight evaluable patients, four had an objective response including one complete response patient who is planned to receive potentially curative allogeneic stem cell transplantation, two marrow complete responses plus hematological improvement and one marrow complete response. The Phase 1 dose-escalation portion of this study will evaluate up to six dose levels of seclidemstat. The maximum tolerated dose, which will inform the Phase 2 portion of the study, was not yet reached. "We are encouraged that this investigator-initiated trial, which is separate from Salarius' sponsored sarcoma trial, shows promising results at this early stage of the study when seclidemstat is combined with azacitidine," said David Arthur, president and chief executive officer of Salarius Pharmaceuticals. "Patients who have failed prior treatments including hypomethylating agents typically have an overall survival of four to six months and are in desperate need of new treatment options. With a 50% overall response rate, including a complete remission planned for potential curative allogeneic stem cell transplantation, we are hopeful that seclidemstat will play a role in their treatment paradigm."
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VTVT RLYB | Hot Stocks08:21 EST vTv Therapeutics appoints Tuch as Chief Financial Officer - vTv Therapeutics (VTVT) announced the appointment of Steven Tuch as Chief Financial Officer, effective immediately. Prior to joining vTv, he served as Head of Corporate Development at Rallybio Corporation (RLYB), leading the Company through its $92.7 million IPO in July 2021. "Steven's success in capital raising and business development, combined with his range of work in the life science and healthcare industry, makes us confident that he is an excellent fit for the position and our needs," said Paul Sekhri, President and Chief Executive Officer of vTv Therapeutics. "We anticipate that he will play a pivotal role as we actively prepare to initiate, then execute on, our Phase 3 trials for our lead drug candidate, TTP399."
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JENGQ | Hot Stocks08:21 EST Just Energy CEO Scott Gahn takes leave of absence for health reasons - Just Energy Group announced that Scott Gahn, its CEO, will be taking an immediate leave of absence for health reasons. The Just Energy Board of Directors has appointed Michael Carter, the Company's CFO, as interim President and CEO, effective immediately. As a member of the leadership team since 2020, Mr. Carter is deeply involved in the operations of Just Energy and, with the support of the other members of the executive management team, is well-positioned to lead the Company out of its restructuring phase, upon the close of the previously announced transaction under the Companies' Creditors Arrangement Act.
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STSS | Hot Stocks08:18 EST Sharps Technology, Nephron Pharmaceuticals sign distribution agreement - Sharps Technology announces the signing of a distribution agreement with partner Nephron Pharmaceuticals. This is a strategic first step in building the larger partnership between the two companies and is in support of their recently announced collaboration. "This distribution agreement opens so many possibilities for Sharps Technology and Nephron Pharmaceuticals," commented Robert Hayes, Sharps Technology CEO. "The timing is perfect in that we are expanding our ability to supply innovative drug delivery systems at a point when the market is in demand for them. Through this distribution plan, Sharps Technology will be able to deliver increased capacity, driving growth for one of the high value product segments of our business." The agreement also allows for Sharps Technology to utilize Nephron's sales and marketing teams to further support the sale of the Company's innovative products to targeted customers within the Nephron customer network. The collaboration between Sharps and Nephron is expected to continue to grow as previously announced, as the companies move forward with the startup of the Inject-EZ operation in South Carolina in early 2023.
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GCAAF | Hot Stocks08:18 EST Guardian Capital to remove lifetime carbon balance by 2040 - Guardian Capital Group announced its commitment to fully remove its lifetime carbon balance - the total greenhouse gas emissions from its operations since the company's inception - by December 31, 2040. Guardian will eliminate its LCB over 19 years, through annual investments in carbon removal projects, in partnership with The Pond Foundation, of which it is a founding member. As part of this initiative, The Pond Foundation team has prepared an assessment and report of Guardian's LCB from the company's inception in 1962 through to December 31, 2021. The evaluation covered over six decades of data and was based on the Greenhouse Gas Protocol, the international standard for corporate accounting and reporting of emissions, which categorizes greenhouse gasses into Scope 1, 2 and 3 emissions, based on the source. Through this analysis, the assessment determined that Guardian's LCB was 35,219 tonnes of C02 equivalent. As a result, in addition to Guardian's existing commitment to balance its annual carbon emissions footprint starting in 2022 by reducing its own emissions and investing in external, nature-based projects that remove carbon from the atmosphere, Guardian has now committed to completely removing these lifetime emissions by the end of year 2040. The amount for the first year will be removed by investing in the following three projects: Ricehouse - Promotes the circular economy from the field to the house with rice-based construction material in Italy. Durrell Rewild Forest Restoration - Contributes to the conservation of 1,000 highly endangered black lion tamarins, restores new forest and creates direct employment for 250 families in their region of Brazil, where poverty incidence is up to 47%. Tanoe-Ehy Forest - Aims to improve livelihoods and governance structures for local people in the Ivory Coast, protect critical habitats and biodiversity, help to reduce illegal logging and bushmeat hunting and more.
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ERAS | Hot Stocks08:17 EST Erasca announces FDA clearance of IND application for ERAS-3490 - Erasca announced the United States Food and Drug Administration, FDA, has cleared an investigational new drug, IND, application for ERAS-3490, an orally available small molecule KRAS G12C inhibitor designed to have high central nervous system, CNS, penetration for the treatment of KRAS G12C-mutated solid tumors, including non-small cell lung cancer, NSCLC. "KRAS G12C is a prevalent oncogenic mutation that was historically considered undruggable. While first generation inhibitors have made great progress against this mutation, we believe that they do not sufficiently penetrate the blood-brain barrier which can lead to poor disease control, particularly in NSCLC, where up to 40% of patients may develop CNS metastases," said Jonathan E. Lim, M.D., Erasca's chairman, CEO, and co-founder. "ERAS-3490, our first homegrown development candidate, was selected for its robust CNS and systemic activity. We are pleased the FDA has cleared our IND for ERAS-3490."
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NUWE | Hot Stocks08:16 EST Nuwellis announces peer-reviewed publication on Aquadex - Nuwellis announced the peer-reviewed publication of the results from a 10-year, real-world retrospective analysis of 334 hospitalized acute decompensated heart failure patients with fluid overload treated with adjustable ultrafiltration using the Aquadex FlexFlow System. Published in the American Heart Journal Plus, the analysis conducted by investigators at Abington Hospital-Jefferson Health in Abington, Pennsylvania demonstrated significant reductions in heart failure hospitalizations and 30-day hospital readmission rates, as well as improvements in renal function response, using Aquadex ultrafiltration. The published study, titled "Ten-Year Real-World Experience with Ultrafiltration for the Management of Acute Decompensated Heart Failure," findings included: Patients experienced an overall 81% decrease in heart failure hospitalizations per year; Rehospitalizations for patients after receiving UF with Aquadex were 48% less than the national average at 30 days; 55% of patients achieved sustained weight loss greater than 15 lbs.; and All patients had stable renal function at follow-up. "These results are consistent with the AVOID-HF Win Ratio analysis recently presented at the Heart Failure Society of America 2022 Annual Scientific Meeting that demonstrated statistically significant clinical superiority of ultrafiltration therapy using the Aquadex System over diuretics in reducing heart failure events within 30 and 90 days," said Nestor Jaramillo, Jr., President and CEO of Nuwellis. "We are grateful to both Dr. Haas and Dr. Robert Watson, Principal Investigator and Chief of Cardiology and Co-Director, and to the study's Sub-Investigators, Maureen Hummel, CRNP, and Patricia Barrella, RN, MSN, for studying their center's experience with Aquadex FlexFlow. We look forward to helping other healthcare providers learn from their findings. Nuwellis is committed to making Aquadex therapy the standard of care for fluid management in heart failure patients that are unresponsive to diuretics."
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JETMF | Hot Stocks08:15 EST Global Crossing Airlines signs LOI for A320 - Global Crossing Airlines Group signed a letter of intent for its tenth passenger aircraft- N286 GX- which is scheduled to join the fleet in February 2023. This aircraft is a sistership to the three ex-Alaska A320s currently flown by GlobalX, with upgraded interior and wi-fi Aircraft Fleet Initiatives: A321 passenger aircraft - N966AD arrived in Miami on December 10 and is undergoing final conformity checks and FAA approvals. It is scheduled to start revenue flying on December 15. This aircraft, with 210 seats, is in high demand by GlobalX's customer base. A321 cargo aircraft- N410 GX- will fly to the paint facility this week and is scheduled to arrive in Miami on December 20. N411 GX - cargo conversion is now completed and the aircraft is undergoing some additional FAA modifications. It will join the fleet once the aircraft is compliant.
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ORIC | Hot Stocks08:14 EST Oric Pharmaceuticals presents preclinical data on ORIC-533 - ORIC Pharmaceuticals presented preclinical ORIC-533 data demonstrating a potential best-in-class CD73 inhibitor profile for the treatment of multiple myeloma."ORIC-533 continues to demonstrate strong potency in reducing adenosine generation and thereby overcoming immune suppression and restoring lysis of multiple myeloma cells as a single agent in ex vivo models," said Jacob M. Chacko, MD, chief executive officer. "We look forward to sharing initial clinical data from the ongoing Phase 1b study of ORIC-533 in patients with multiple myeloma in the first half of 2023." Key highlights from the presentation include: Preclinical analyses continue to show ORIC-533 demonstrates a potential best-in-class CD73 inhibitor profile. ORIC-533 overcame immune suppression and triggered significant lysis of multiple myeloma cells across all dose levels tested and in a dose-responsive manner, in an autologous ex vivo assay using samples derived from bone marrow aspirates from patients with relapsed refractory multiple myeloma. Together these preclinical data confirm that single agent ORIC-533 inhibits CD73 to potently reduce adenosine generation, overcome immune suppression and restore lysis of multiple myeloma cells and therefore holds potential as a treatment for patients with multiple myeloma.
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SLRX | Hot Stocks08:12 EST Salarius Pharmaceuticals presents SP-3164 data - Salarius Pharmaceuticals announces that yesterday Daniela Santiesteban, Ph.D., Salarius' director of targeted protein degradation development, presented positive SP-3164 preclinical data at the 64th American Society of Hematology, ASH, Annual Meeting and Exposition underway in New Orleans and virtually. SP-3164 is an oral, next-generation molecular glue that uses deuterium to stabilize the preferred (S)-enantiomer of avadomide and thereby prevents interconversion into the unwanted (R)-enantiomer of avadomide. The poster - titled "SP-3164, a Novel Cereblon-Binding Protein Degrader, Shows Activity in Preclinical Lymphoma Models" - demonstrated that in lymphoma cells, SP-3164 interacts with the cereblon component of a CRL4 E3 ligase, inducing recruitment and subsequent degradation of the hematological transcription factors Ikaros and Aiolos, which play a critical role in regulating B and T cell development. Like other Ikaros and Aiolos degraders such as lenalidomide and avadomide, SP-3164 demonstrates compelling activity in NHL and may have potential safety and efficacy advantages over other molecular glues. Data highlights included in the poster, available here, include: SP-3164 induced rapid and efficient Ikaros degradation compared to other studied molecular glues; SP-3164 exhibited antiproliferative effects across several NHL cell lines; SP-3164 pharmacokinetics showed exclusive exposure to the preferred (S)-enantiomer; SP-3164 demonstrated single-agent activity in DLBCL mouse model and superiority to lenalidomide; SP-3164 resulted in complete regressions in 50% of mice when treated in combination with rituximab in a DLBCL mouse model and performed significantly better than the approved regimen of lenalidomide and rituximab
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BYSI | Hot Stocks08:10 EST BeyondSpring presents plinabulin data in DIN in NSCLC patients - BeyondSpring announced data from the ESMO Asia Congress 2022 and the American Society of Hematology Annual Meeting about the use of lead asset, plinabulin, for the prevention of docetaxel-induced neutropenia in non-small cell lung cancer patients. In addition, data was presented on plinabulin for the prevention of docetaxel-induced neutropenia in breast cancer at the 2022 San Antonio Breast Cancer Symposium. The analyses in the NSCLC studies support the efficacy of plinabulin as a monotherapy in reducing the mean duration of severe neutropeniawith a greater than1 day benefit for patients receiving docetaxel and plinabulin in two independent randomized trials. Title: Prevention of Docetaxel Induced Neutropenia with Single Agent Plinabulin Versus Control in Non-Small Cell Lung Cancer in Two Randomized Trials: The presentation summarized data from two randomized NSCLC studies, and DIN results were compared between the plinabulin arm and the control arm. The DSN was calculated based on Day 8 absolute neutrophil count values in the plinabulin and control arms. In NSCLC patients, docetaxel 75 mg/m2 is typically used without G-CSF prophylaxis. This analysis focuses on the effectiveness of plinabulin vs. control for the prevention of DIN in the 101 and 103 studies. In summary, in these two independent randomized studies, plinabulin demonstrated a superior benefit for Gr4N, Gr3/4N, all GrN and DSN compared to the control. Importantly, in both these randomized studies, there was a reduction in mean DSN of greater than1 day for plinabulin vs. control. Title: Superior single agent effectiveness with plinabulin versus placebo for docetaxel-induced neutropenia prevention in non-small cell lung cancer patients: The presentation summarized DIN data from a non-randomized comparison derived from two different studies: plinabulin data from study 105 and the control data from study 103. In the 105 study, NSCLC pts with at least one febrile neutropenia risk factor received docetaxel 75 mg/m2 with plinabulin. In the 103 study, patients received docetaxel 75 mg/m2 without plinabulin. In summary, plinabulin was superior for the prevention of DIN and hematologic complications vs control: Grade 4 Neutropenia: 17% with plinabulin vs 40% with placebo. In addition, the mean DSN was 0.43 days for plinabulin vs. 1.32 days for placebo. There was also a favorable quality of life and safety profile with plinabulin. Title: Superior effectiveness of Plinabulin versus no-treatment for Docetaxel-induced neutropenia and other hematologic complication in breast cancer patients: The presentation summarized DIN data for plinabulin from study 105 and the control data was taken from the literature. The hematologic complications endpoints from the 27 early breast cancer patients with at least one NCCN high FN risk factor from the Phase 3 portion of 105 study were compared with the no-treatment studies from literature where patients were given 75 mg/m2 docetaxel without G-CSF. Blood sampling in the no-treatment studies were infrequent and likely underestimated the true grade 4 neutropenia frequency. In summary, despite a higher frequency of ANC sampling in cycle 1, plinabulin was superior vs no-treatment for DIN and hematologic complications. Quality of life was maintained, and there were minimal adverse effects including minimal bone pain burden in the plinabulin arm vs. no-treatment.
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FATE | Hot Stocks08:10 EST Fate Therapeutics announces data on approaches to cancer immunotherapies - Fate Therapeutics presented preclinical data of several novel strategies designed to enable administration of off-the-shelf cell-based cancer immunotherapies without conditioning chemotherapy at the 64th American Society of Hematology, ASH, Annual Meeting and Exposition. Conditioning chemotherapy, commonly used throughout the field of cell therapy, often results in hematologic toxicities, can limit the potential for administration of multiple doses, and can prohibit adoption as part of early-line treatment. "Eliminating the need for conditioning chemotherapy has the potential to significantly improve the safety and clinical benefit of cell therapies, and enable their use in a significantly broader population of patients with hematologic malignancies and solid tumors. Our next-generation iPSC product platform seeks to create the ideal off-the-shelf cell therapy, which would enhance functional persistence and anti-tumor activity while reducing or eliminating the need for conditioning chemotherapy to deplete host lymphocytes," said Bob Valamehr, Ph.D., Chief Research and Development Officer of Fate Therapeutics. "We are developing multiple promising strategies that can only be realized through precise multiplexed-engineering of cells, and we believe our leading iPSC product platform is uniquely positioned to generate clonal NK and T-cell product candidates that can thrive and resist rejection."
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MAIA | Hot Stocks08:09 EST MAIA Biotechnology expands Phase 2 THIO-101 trial to Europe - MAIA Biotechnology announced that regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, have approved the implementation of THIO-101, MAIA's Phase 2 clinical trial evaluating its lead therapeutic candidate, THIO, in patients with Non-Small Cell Lung Cancer NSCLC. The first patients in THIO-101 were dosed in Australia earlier this year. THIO-101 is designed to evaluate THIO's potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of Regeneron's anti-PD1 therapy, Libtayo or cemiplimab , allowing for immune system activation and sensitivity to the PD-1 inhibitor to take effect. The primary objectives of the trial are to evaluate the safety and tolerability of THIO administered as a direct anticancer and priming immune system agent prior to cemiplimab administration, as well as to evaluate the clinical efficacy of THIO in patients with advanced NSCLC who either progressed or relapsed through treatment with an immune-check point inhibitor alone or in combination with chemotherapy. "Adding EU sites to the THIO-101 study increases patient access to THIO on a global scale. Lung cancer is the second most common cancer indication, so addressing it requires worldwide research efforts," said MAIA Chief Medical Officer Mihail Obrocea, M.D. "Adding EU sites to THIO-101 officially makes it a global trial. We believe the data that THIO-101 generates will further validate THIO and be a major step towards bringing effective therapies to lung cancer patients."
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SATL | Hot Stocks08:07 EST Satellogic signs LOI with AEM for satellite earth observation platform - Satellogic announced that it has signed a letter of intent with Agencia Espacial Mexicana to develop a fully-featured and operational Constellation-as-a-Service program to monitor approximately 2M square kilometers of the nation. The LOI provides a framework for the development of a Constellation-as-a-Service program, leveraging Satellogic satellites to deliver high-resolution multispectral imagery to support Mexico's innovation and participation in the New Space economy with multipurpose, country-wide monitoring up to three times a year, enhancing Mexico's EO competence via commercial capabilities. The LOI also includes details for a pilot project with AEM to utilize archive imagery. "Satellogic's unique Constellation-as-a-Service model provides a low-risk, cost-effective entry point for nations to leverage Earth Observation satellites for geospatial science advancement, and economic prosperity, as well as emergency response and sustainability planning," said Thomas VanMatre, VP of Global Business Development at Satellogic. "Governments and agencies throughout the region are focusing more intently on the benefits of satellite data and are excited to work with Satellogic to demonstrate for their nations what can be achieved with our high-capacity, high-resolution constellation."
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IMMX | Hot Stocks08:07 EST Immix Biopharma announces patient dosing in Phase 1b/2a IMX-110 trial - Immix Biopharma announced patient dosing in its ongoing Phase 1b/2a IMX-110 monotherapy clinical trial. This is the fifteenth patient dosed with IMX-110 to-date. IMX-110 clinical trial data is expected to be released on a rolling basis beginning in Q1 2023; once dosing begins, patients undergo CT scans every 8 weeks to assess tumor response to IMX-110. IMX-110 monotherapy and IMX-110 combination clinical trial with Beigene/Novartis anti-PD-1 tislelizumab are enabled by newly manufactured, scaled-up IMX-110 GMP batches produced using our proprietary process. "We are thrilled to accelerate our efforts to bring IMX-110 to patients after scaling-up manufacturing of IMX-110," said Ilya Rachman, MD PhD, CEO of ImmixBio. "Key opinion leaders at our 5 clinical trial sites are excited to bring IMX-110 to their adult and pediatric cancer patients as a monotherapy and as a combination with Beigene/Novartis anti-PD-1 tislelizumab."
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JEWL | Hot Stocks08:06 EST Adamas One announces key trademarks supporting marketing, branding - Adamas One announces it has trademarked key branding elements. The newly trademarked content includes, "The Original Lab Grown Diamond Company." Adamas One possesses key intellectual property that can traced back to the original CVD process for lab-grown diamonds. The second trademark covers the Company tagline, "Not mined. Not fake. Just sped up perfection." Jay Grdina, Adamas One's CEO, comments, "These trademarks are an important element of our ongoing marketing. Following our recent IPO, we are dedicated to more aggressive outreach, and these trademarked elements will provide us with stronger positioning and brand engagement as we enter the holiday season and the new year."
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BAESY | Hot Stocks08:05 EST BAE Systems signs two contracts worth $32M for Bofors 57mm ammunition - BAE Systems has signed two contracts worth approximately $32M for its market-leading Bofors 57mm 3P advanced ammunition in a combined procurement from both the Swedish Defence Materiel Administration, or FMV, and the Finnish Defence Forces Logistics Command, or FDF LOG COM. Sweden is ordering a large stock of the Bofors 57mm 3P advanced ammunition, for an order value of approximately $18M. This is a critical step for the Swedish Armed Forces as they continue their efforts to increase readiness in the face of the current security situation in Central Europe. The FMV also has a contract option for additional quantities in 2023. Finland is also ordering a considerable stock of rounds of the ammunition, valued at approximately $14 million. This is an important step in reinforcing the security of supplies as Finland, and in particular the Finnish Navy, also confirms its readiness.
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KACL | Hot Stocks08:04 EST Wellous, Kairous Acquisition enter definitive merger agreement - Wellous Group and Kairous Acquisition announced that it has entered into a definitive merger agreement that will result in Wellous becoming a publicly listed company upon the closing of the transaction contemplated there in. Upon closing, the combined company will be renamed "Wellous Group Holdings Limited" and expects to list its ordinary shares on Nasdaq. Founded in 2016, Wellous started off as a homegrown brand focusing on sharing and harnessing the benefits of mother nature to communities through carefully curated formulations. The Company prides itself not only as a nutrition company aiming to provide health food and supplements that meet, and exceed the expectations of its product users, but also as an innovative technology-forward company with a platform available to its thousands of "techpreneurs" - individuals with sophisticated social media marketing skills, as well as nutrition and fitness knowledge-transfer capabilities - to utilize the Company's Five5S sales platform to establish, enhance and expand its relationship with product users. Wellous sources its ingredients naturally, from geographically diverse origins, and works diligently to ensure it upholds high standards while curating its products. Wellous and its products are trusted brands, as evidenced by numerous awards accumulated over the past several years. As provided in the Merger Agreement, the merger consideration is $270 million, payable by newly-issued securities of the Combined Company valued at $10.10 per share. Additional earnout shares may be issuable to Wellous stockholders after closing, upon achievement of certain trading price-based and/or profitability targets. Cash proceeds raised will consist of Kairous's approximately $21 million in trust which is anticipated to support the Company's growth capital needs and to be used for general working capital purposes. After the closing, Wellous shareholders are expected to retain a majority of the outstanding shares of the Combined Company and Wellous will designate a majority of proposed directors for the Combined Company's board. The Wellous management team, led by its co-founders Andy Tan and Henry Chin, will continue to run the Combined Company after the closing of the Proposed Transaction. The boards of directors of both Wellous and Kairous have unanimously approved the Proposed Transaction, which is expected to be completed in mid-2023, subject to, among other things, approval by Kairous' and Wellous' shareholders, and satisfaction of the conditions provided in the Merger Agreement, including regulatory approvals and other customary closing conditions, including a registration statement in connection with the Proposed Transaction being declared effective by the U.S. Securities and Exchange Commission .
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MULN | Hot Stocks08:03 EST Mullen Automotive signs first U.S. dealer partner, Randy Marion Automotive - Mullen Automotive announces Randy Marion Automotive as the first dealer group partner for Mullen's commercial EV lineup, which is set to launch in the U.S. in 2023. Mullen's commercial EV lineup includes Class 1-3 cargo van and cab chassis offerings and Bollinger Motors Class 4-6 chassis products. "We are excited to bring on such a tremendous dealer partner that is so well respected and recognized throughout the commercial industry," said David Michery, CEO and chairman of Mullen Automotive. "Randy and his team recognize the opportunity with Mullen's commercial vehicles and are poised to be a critical partner for us."
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EYEN | Hot Stocks08:02 EST Eyenovia announces FDA acceptance of NDA for MydCombi - Eyenovia announced that the U.S. Food and Drug Administration, FDA, has accepted for review the company's New Drug Application, NDA, for MydCombi ophthalmic spray. MydCombi is a drug-device combination product that comprises the company's proprietary, first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation, administered via the investigational Optejet drug delivery technology. The agency has assigned the resubmitted NDA a standard review with a Prescription Drug User Fee Act target action date of May 8, 2023. The FDA also indicated that it is currently not planning to hold an advisory committee meeting to discuss the application. "Acknowledgement of our MydCombi NDA is a significant step forward in our quest to bring a paradigm change in the way that topical eye drugs are developed and delivered, and we look forward to working with FDA during its review," stated Michael Rowe, Chief Executive Officer of Eyenovia. "If approved, MydCombi would be the first commercial product to leverage our proprietary Optejet drug delivery device, which we believe could bode well not only for our other internal development programs for presbyopia and progressive myopia but our ongoing partnering discussions as well." The MydCombi NDA is supported by two completed Phase 3 clinical trials, MIST-1 and MIST-2. The MIST-1 trial compared MydCombi to phenylephrine alone and tropicamide alone, while MIST-2 compared MydCombi to placebo. All treatments were administered using Eyenovia's Optejet technology.
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LDOS | Hot Stocks08:02 EST Leidos selected to upgrade Atlanta International Airport's security checkpoints - Leidos was selected by New-South Synergy to upgrade U.S. Transportation Security Administration checkpoints at Hartsfield-Jackson Atlanta International Airport. The upgrades are part of a larger initiative to expand and enhance the airport's security checkpoints by leveraging the latest technologies, while also improving the passenger experience. The upgrade will update security lanes at the Domestic Terminal Main Security Checkpoint with Leidos' Advanced Imaging Technology.
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ATA | Hot Stocks08:02 EST Americas Technology Acquisition announces liquidation - Americas Technology Acquisition announced that due to its inability to consummate an initial business combination by such date, the Board of Directors of ATA has elected to dissolve and liquidate ATA in accordance with the provisions of its Amended and Restated Memorandum and Articles of Association, as amended , and will redeem all of the outstanding ordinary shares that were included in the units issued in its initial public offering, at a per-share redemption price of approximately $10.59. As of the close of business on December 17, 2022, the Public Shares will be deemed cancelled and will represent only the right to receive the redemption amount. In order to provide for the disbursement of funds from the trust account, ATA will instruct the trustee of the trust account to take all necessary actions to liquidate the securities held in the trust account. The proceeds of the trust account will be held in a non-interest bearing account while awaiting disbursement to the holders of the Public Shares. Record holders will receive their pro rata portion of the proceeds of the trust account by delivering their Public Shares to Continental Stock Transfer & Trust Company, the Company's transfer agent. Beneficial owners of Public Shares held in "street name," however, will not need to take any action in order to receive the redemption amount. The redemption of the Public Shares is expected to be completed within ten business days after December 17, 2022. The Company's sponsor has agreed to waive its redemption rights with respect to its outstanding ordinary shares issued prior to ATA's initial public offering. There will be no redemption rights or liquidating distributions with respect to ATA's warrants, which will expire worthless.
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WEC | Hot Stocks08:01 EST WEC Energy plans to raise quarterly dividend 7.2% in 1Q23 - The board of directors of WEC Energy Group announced that it is planning to raise the quarterly dividend on the company's common stock to 78c per share in the first quarter of 2023. This would represent an increase of 5.25c per share, or 7.2%. The directors expect to declare the new dividend at their regularly scheduled meeting in January. The dividend - which would be equivalent to an annual rate of $3.12 per share - would be payable March 1, 2023, to stockholders of record on Feb. 14, 2023.
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RAMPF | Hot Stocks07:57 EST Polaris Renewable Energy appoints Catherine Fagnan as consultant to the board - Polaris Renewable Energy is adding Catherine Fagnan as a Consultant to the Board until the next Annual General Meeting, expected to be held in June 2023. Catherine will work with, and advise, the Board, on a variety of initiatives, including ESG matters, for which she has in depth knowledge and experience. It is anticipated that Catherine will be included in management's nominees to the Board for the 2023 AGM. Catherine currently acts as Associate General Counsel for Green Infrastructure Partners.
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SLGGF | Hot Stocks07:49 EST Cornerstone files management information circular for SolGold arrangement - Cornerstone Capital Resources announced that it has filed and commenced mailing its management information circular and related materials in connection with the special meeting of Cornerstone shareholders to be held in virtual-only format via live webcast at 9:00 a.m. on January 9, 2023 to approve the previously-announced plan of arrangement with SolGold, all as more particularly described in the Circular.The Circular provides important information regarding the Arrangement and related matters, including the background to the Arrangement, the reasons for unanimous recommendation of the board of directors of Cornerstone, voting procedures and how to virtually attend the Meeting. Shareholders are urged to read the Circular and its appendices carefully and in their entirety. The Circular and the related materials in connection with the Meeting are being mailed to Shareholders in compliance with applicable laws and interim order of the Court of King's Bench of Alberta granted on December 6, 2022 and are available under Cornerstone's issuer profile on SEDAR at www.sedar.com. The Board of Directors unanimously recommends that the Shareholders vote FOR the Arrangement. Since announcement of the Arrangement, SolGold has raised gross proceeds of US$86M through royalty and equity financings. SolGold is well positioned to advance the ongoing strategic review process while continuing to advance and de-risk the world class Cascabel project. In connection with SolGold's upcoming annual general meeting, not in connection with the Arrangement, to be held on December 22, 2022, Cornerstone is pleased to report that it has voted FOR all resolutions proposed to be approved by SolGold shareholders.
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VMAR | Hot Stocks07:48 EST Vision Marine enters formal Supplier Agreement with Groupe Beneteau - Vision Marine Technologies announces that Vision Marine has entered into a formal Supplier Agreement with Groupe Beneteau. This agreement further solidifies the relationship between Vision Marine and Beneteau, which was previously announced on July 19, 2022. The Four Winns H2e, the first purpose built electric runabout available to consumers, will be jointly marketed to Beneteau's dealer network by Vision Marine and Beneteau. Beneteau's extensive dealer network includes 72 dealers throughout the United States, and 400 worldwide, on five continents. "We are proud to enter into this strategic global supplier alliance with Groupe Beneteau. This represents an exciting milestone and inflection point for Vision Marine and its shareholders. We look forward to sharing our mutual mandates, and to assist Beneteau to expand its global carbon neutral goals via the electric transition of global waterways." stated Alex Mongeon, co-founder, and CEO of Vision Marine. "We expect our order book to show continuous growth as we approach the formal introduction of the H2e, as well as other offerings by Beneteau."
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J | Hot Stocks07:47 EST Jacobs providing consulting services to US air bases in Japan - Jacobs was selected to provide professional facility planning, programming, design and construction management services for the U.S.Air Force at Yokota Air Base, Misawa Air Base and Camp Zama, Japan. This indefinite delivery indefinite quantity architecture and engineering services contract for the USAF 374th Airlift Wing, Yokota Air Base, Japan has a shared potential ceiling across multiple awardees of $99M. The contract has an initial five-year base period with the option to renew for an additional two years.
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APEN | Hot Stocks07:47 EST Apollo Endosurgery announces two milestones for endoscopic systems - Apollo Endosurgery announced that the MERIT trial, published in The Lancet earlier this year, was selected as 2022 Top Story in Gastroenterology. Additionally, the American Society for Metabolic and Bariatric Surgery formally added four Apollo systems to its list of FDA Approved Bariatric Devices on December 5. These milestones come only months after Apollo received FDA marketing authorization for Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx to facilitate weight loss in patients with obesity. In the Expert Opinion article published in Gastroenterology announcing the selection of the MERIT trial as the 2022 story of the year, Dr. Steven A. Edmundowicz, Past President and Master of the American Society for Gastrointestinal Endoscopy, highlighted the outcomes of the MERIT trial, including 77% of the ESG group reaching 25% or more excess weight loss versus 12% in control group, low adverse event rate managed without ICU care or surgery, and 80% of ESG group with improvement in one or more metabolic comorbidity. Dr. Edmundowicz also called for a "unified approach" among gastroenterology and surgical societies to support patients with obesity and in the pursuit of insurance coverage. The selection of the MERIT trial follows just days after Endoscopic Sleeve Gastroplasty and Transoral Outlet Reduction and Apollo Revise Sx Endoscopic Suturing System were added to the FDA Approved Bariatric Devices list by ASMBS. ASMBS endorsed procedures and FDA approved medical devices do not require IRB approval in accredited MBSAQIP-Accredited centers. Physicians will now be able to perform these procedures with the FDA authorized devices at MBSAQIP accredited centers without the need for IRB approval; procedures will also be included in the MBSAQIP database.
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CLLS | Hot Stocks07:46 EST Cellectis announces preliminary data for UCART22, UCART123 - Cellectis will host a live webcast reviewing updated clinical data on its Phase 1/2a BALLI-01 clinical trial and on its Phase 1 AMELI-01 clinical trial that were presented in an oral session on December 12, 2022 at the 64th Annual Meeting of the American Society of Hematology, ASH. BALLI-01 is a Phase 1/2a open-label dose-escalation trial evaluating the safety and clinical activity of UCART22 given at escalating dose levels after lymphodepletion with either fludarabine and cyclophosphamide or FC with alemtuzumab in patients with relapsed or refractory acute lymphoblastic leukemia. Alemtuzumab was added to the LD regimen to sustain host T-cell and Natural Killer cell depletion and to promote UCART22 cell expansion and persistence. Compared to the last clinical update on BALLI-01 at ASH 2021, the webcast presented data from five additional patients who received UCART22 at dose level 3 5x106 cells/kg after lymphodepletion with FCA. No dose limiting toxicities, Grade 2 or higher cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome or adverse events of special interest were observed. Evidence of UCART22 anti-tumor activity was observed in 60% (n=3) of the five patients at DL3 after lymphodepletion with FCA: A patient experienced a durable minimal residual disease negative complete response with incomplete count recovery that continues beyond 6 months. A patient experienced an MRD negative complete response that continues beyond Day 56. A patient experienced a morphologic leukemia-free state that continues beyond Day 84. All three of the responders failed multiple lines of prior therapy including chemotherapy, CD19-directed autologous CAR T cell therapy, and allogeneic stem cell transplant. Additionally, the patient with the MRD negative CR also failed both prior blinatumomab and inotuzumab. Overall, these preliminary data support the continued administration of UCART22 after FCA lymphodepletion in patients with r/r ALL. The Company is now enrolling patients in BALLI-01 with product candidate manufactured fully in-house at DL2 after FCA lymphodepletion. The first patient has been dosed at dose level 2 1x106 cells/kg. The next data set is expected to be released in 2023.
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TMDI | Hot Stocks07:45 EST Titan Medical announces USPTO granted patent covering user experience - Titan Medical announced that the United States Patent and Trademark Office, USPTO recently issued patent No. 11,504,191, titled "Graphical User Interface for a Robotic Surgical System." The patent, directed at enhancing the surgeon user experience, generally covers a graphical user interface overlay of a surgical workspace to track instrument movement. "The granting of this patent is a result of our strategic plan to independently build and protect a robust patent portfolio in robotic assisted surgery, including around the Enos robotic single access surgical system. Today's news validates our commitment to the continuum of innovation in robotic assisted surgery," stated Cary Vance, President, and CEO of Titan. "Along with recent patent application filings, including some that have recently published, this patent demonstrates the company's focus on being an innovation leader in single-access RAS. The technology covered in this patent could assist with early-stage artificial intelligence that works to limit movement of instruments, including movements based on patient anatomy or more general keep-out zones, as well as enhancements in single-access RAS beyond the Enos system, including next generation single-access RAS technologies and systems. We believe the breadth and depth of our patent portfolio provides us with options for monetization or other strategic opportunities." The granted patent covers technology that generates a three-dimensional boundary for instruments within the surgical workspace, based on movement generated by a user-controlled hand controller.
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JUSHF | Hot Stocks07:42 EST Jushi Holdings unveils cannabis brand portfolio in California - Jushi Holdings announced the launch of a comprehensive product suite in California that includes three brands crafted to meet cannabis consumers' preferences and price points. With the addition of Seche Pre-Roll Singles, Tasteology Fruit Chews and The Lab Vapes, the Company brings a new selection of high-quality brands and proprietary products exclusively available at the Company's Beyond Hello retail locations in the Golden State. "As California is one of the most competitive and mature cannabis markets in the world, California cannabis consumers have some of the most discerning tastes," said Jim Cacioppo, CEO. "They want high-quality products at a range of price points that deliver a premium consumer experience. Our diverse house of brands has been carefully crafted to meet the needs of the canna-curious and the canna-connoisseurs alike. As we expand Jushi's branded product portfolio in key markets across the country, we look forward to exceeding consumers expectations by offering new, innovative brands and products through our digital and retail store footprint."
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ENVX | Hot Stocks07:41 EST Enovix receives ISO 9001:2015 certification - Enovix Corporation announced it received ISO 9001:2015 certification, a rigorous international evaluation process that validates the company's end-to-end business processes meet industry-recognized standards. ISO 9001:2015 is a certification from the International Organization for Standardization, an independent, non-governmental body that ensures companies provide their customers with consistent, quality products and services.
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IPIX | Hot Stocks07:40 EST Innovation Pharmaceuticals reports in vivo antifungal data on Brilacidin - Innovation Pharmaceuticals provided an update on ongoing research on the broad-spectrum antifungal activity of Brilacidin, the Company's defensin mimetic drug candidate exhibiting antimicrobial and immunomodulatory properties. New in vivo data in an A. fumigatus murine fungal keratitis model showed Brilacidin reduced fungal burden and disease severity, while also improving corneal thickness compared to control. Brilacidin-treated corneas harbored almost no viable fungus, suggesting the compound suppressed fungal proliferation within the cornea. Worldwide, on an annual basis, fungal keratitis affects up to 1.5 million people, of whom 75 percent may lose an eye and/or their sight. These new Brilacidin findings in fungal keratitis complement an earlier in vitro and in vivo evaluation of Brilacidin as an ocular anti-infective in bacterial keratitis. A broad-spectrum drug that could target both fungal and bacterial keratitis would be uniquely positioned as to its treatment profile and commercial potential. Planned next steps in Brilacidin antifungal research include extending in vitro and in vivo testing into additional clinical isolates and animal models, and publishing scientific findings. In collaboration with the NIH/NIAID's mycology division, Brilacidin also is to be screened in multiple fungal species to further characterize its broad-spectrum antifungal activity. Future updates are planned.
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APEN | Hot Stocks07:40 EST Apollo Endosurgery advances endoscopic procedures for obese patients - Apollo Endosurgery announced that the MERIT trial, published in The Lancet earlier this year was selected as 2022 Top Story in Gastroenterology. Additionally, the American Society for Metabolic and Bariatric Surgery ASMBS formally added four Apollo systems to its list of FDA Approved Bariatric Devices on December 5. These milestones come only months after Apollo received FDA marketing authorization for Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx to facilitate weight loss in patients with obesity .In the Expert Opinion article published in Gastroenterology announcing the selection of the MERIT trial as the 2022 story of the year, Dr. Steven A. Edmundowicz, Past President and Master of the American Society for Gastrointestinal Endoscopy ASGE , highlighted the outcomes of the MERIT trial, including 77% of the ESG group reaching 25% or more excess weight loss versus 12% in control group, low adverse event rate managed without ICU care or surgery, and 80% of ESG group with improvement in one or more metabolic comorbidity. Dr. Edmundowicz also called for a "unified approach" among gastroenterology and surgical societies to support patients with obesity and in the pursuit of insurance coverage.
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AMED | Hot Stocks07:40 EST Amedisys closes on home health JV with University of Arkansas - Amedisys has closed on its joint venture with the University of Arkansas for Medical Sciences to provide home health services in Searcy and Little Rock. This joint venture is part of the partnership between UAMS, Amedisys and Contessa, an Amedisys company, to offer patients a full spectrum of medical care in the comfort and convenience of their own homes through UAMS Health Comprehensive Care at Home. Clinical services will include Recovery Care at Home, Rehabilitation Care at Home, Palliative Care at Home, Primary Care at Home and Home Health. Home health services include skilled nursing care; physical, occupational and speech therapy; medical social work; and home health aides to assist with activities of daily living, such as bathing, dressing and eating. Home health services will operate as UAMS Health Home Health across 12 counties in Central Arkansas.
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CNM | Hot Stocks07:40 EST Core & Main sees FY22 adjusted EBITDA $910M-$930M - "We expect to deliver strong performance in the fourth quarter despite the 50% net sales growth we achieved in the same period last year," LeClair continued. "We expect demand to remain resilient, supported by our balanced business mix and the execution of our growth initiatives. We remain confident in the long-term stability of our business and end-markets, as roughly half of our net sales are driven by non-discretionary repair and replacement activity. Taken altogether, we are raising our expectation for fiscal 2022 Adjusted EBITDA to be in the range of $910 to $930 million, representing year-over-year growth of 51% to 54%."
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ABUS | Hot Stocks07:39 EST Arbutus Biopharma completes enrollment in Phase 2 trial with AB-729, NA therapy - Arbutus Biopharma announced preliminary data from the AB-729 lead-in portion of its Phase 2a clinical trial combining AB-729 with nucleos(t)ide analogue therapy and Peginterferon alfa-2a. The data reinforces AB-729's surface antigen reducing-capacity, while continuing to exhibit a generally safe and well-tolerated profile in patients with chronic Hepatitis B virus. Given that only a few patients are in the early weeks of the IFN phase of the clinical trial, the Company intends to provide additional updated data in the first half of next year which will include preliminary results of the IFN portion of the trial. Enrollment is complete in the clinical trial with 43 patients having received at least one dose of AB-729. For the first 15 patients who reached week 16 of treatment and received two doses of AB-729 plus NA therapy, the mean HBsAg decline was 1.51 log, comparable to the decline observed at the same timepoint in the completed Phase 1b clinical trial AB-729-001. As the trial progresses, patients will be randomized into various treatment arms which include the combination of AB-729, NA therapy and short courses of IFN for either 12 or 24 weeks. The randomized, open label, multicenter Phase 2a proof-of-concept clinical trial is designed to investigate the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of IFN. After completion of the assigned IFN treatment period, all patients will remain on NA therapy for an additional 24-weeks and will then discontinue NA treatment provided they meet pre-defined stopping criteria. Patients who stop NA therapy will enter an intensive follow-up period of 48 weeks.
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SYNH | Hot Stocks07:39 EST Syneos Health extends partnership with Medable - Syneos Health extended its strategic partnership with Medable, the industry-leading technology platform for patient-centered clinical trials, as part of the Company's commitment to bring clinical trials closer to the patient. Together, Syneos Health and Medable will continue to reduce site and patient burden, improve enrollment and retention and increase patient access and diversity through innovative decentralized clinical trial solutions. Syneos Health first partnered with Medable in April 2021. Notably, over the past 18 months, Syneos Health and Medable have collaborated on more than 15 clinical trials with the aim of reaching 21,000 patients across multiple therapeutic areas. Extended work will continue to successfully deliver technology-enabled, insights-driven DCT solutions to address customers' customized needs.
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MGTX | Hot Stocks07:38 EST MeiraGTx announces clinical data from the AQUAx Phase 1 study of AAV2-hAQP1 - MeiraGTx announced positive clinical data from the ongoing Phase 1 AQUAx study of AAV2-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia. AQUAx is an open label, multi-center, dose escalation study of a single administration of AAV2-hAQP1 to one or both parotid glands in patients with radiation-induced salivary hypofunction and grade 2/3 xerostomia. As of the cutoff date of November 30, 2022, all 12 unilaterally treated participants have undergone their 12-month assessment, with 3 having completed their 24-month assessment and one having completed their 36-month assessment in the long-term follow-up study. Efficacy Data presented from the 24 participants treated in the AQUAx study: Clinically meaningful improvements in xerostomia symptoms reported consistently across two validated PROs assessing xerostomia symptom severity; Meaningful increases in whole saliva flow rates observed post-treatment, providing objective evidence of biological activity of AAV2-hAQP1 treatment; Early long-term follow-up data suggest durability of improvement 2+ years post-treatment. Global Rate of Change: Bilateral Cohorts to 6 Months: 10/12 participants reported symptoms of dry mouth as "better" at the 6 month timepoint; No participant reported any worsening of xerostomia symptoms. Unilateral Cohorts to 12 Months: 8/12 participants who reached the 12-month assessment reported symptoms of dry mouth as "better" following treatment; Improvement in xerostomia symptoms can be seen persisting through 2 years in all 3 patients who have reached that timepoint; Participant 1-1 reached the 3-year assessment and the maximum score of 7 was maintained; No participant reported any worsening of xerostomia symptoms. Combined Unilateral and Bilateral Cohorts: 18/24, or 75%, of all unilateral and bilateral treated participants reported symptoms of dry mouth as "better" following treatment; In the overall cohorts the average improvement in scores was greater in bilateral participants compared to unilateral participants; Unilateral cohort achieved overall improvement of greater than3 points at 12 months; Bilateral cohort achieved overall improvement of greater than3 points at 2 months and an overall improvement of 4 points by 6 months; overall improvement in scores was maintained and increased over time in both unilateral and bilateral cohorts
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XTRAF | Hot Stocks07:37 EST Xtract One says Tachi Palace Casino Resorts to expand use of SafeGateway tech - Xtract One announced that Tachi Palace Casino Resorts has expanded its use of Xtract One's SafeGateway weapons detection technology to accommodate the venue's growth. Tachi, owned by the Tachi-Yokut Native American tribe, first purchased Xtract One gateway technology in July 2021. The new resort expansion spans more than 300,000 square feet, encompassing a casino, hotel and resort, entertainment center, gas station and more. As a result of Tachi's positive experience with Xtract One's SafeGateway system, the company will expand the use of SafeGateway to all entrances of the newly built complex. Tachi is reporting that Xtract One's solution has significantly increased the safety and customer experience at the venue, with the SafeGateway detecting an average of more than seven guns and 450 knives per month. Patrons arriving at the resort enjoy secure, fast entry - simply "walking-right-in" without delays, or invasive scanning.
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INDP | Hot Stocks07:35 EST Indaptus Therapeutics initiates first-in-human Phase 1 trial of Decoy20 - Indaptus Therapeutics announces the initiation of INDP-D101, its first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors. The USC Norris Cancer Center in Los Angeles, California is the first activated clinical trial site that has been opened for patient enrollment, and patient screening is expected soon. The study's objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose and recommended phase 2 dose, as well as to assess Decoy20 pharmacokinetics, pharmacodynamics and clinical activity. The Phase 1 study will begin with a single dose escalation part followed by an expansion part with continuous administration of Decoy20. The study will enroll patients with advanced/metastatic solid tumors, who have exhausted the other known treatment options. Primary endpoint of the study is incidence, relatedness and severity of adverse events and treatment-emergent adverse events and determining the number of subjects per cohort with dose limiting toxicity-based adverse events. Secondary endpoints include the incidence of anti-drug antibodies and neutralizing antibodies pre- and post-treatment, change in Decoy20 PK parameters over time, objective response rate in subjects with measurable disease and duration of response.
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OPGN | Hot Stocks07:34 EST OpGen announces data from trial for Unyvero Urinary Tract Infection Panel - OpGe announced top line data from its successfully completed Unyvero UTI clinical trial. OpGen's Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens. The test aims at quantitative detection of microorganisms. The trial was designed to compare the performance of the Unyvero UTI Panel for detecting urinary tract infections, UTI, using clean-catch or catheter related urine samples. Preliminary analysis of all prospectively enrolled samples showed that the primary study endpoint was successfully met by demonstrating an overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% when compared against each trial site's standard of care microbiology results. The trial included a total of 1,858 prospective and archived samples and has run over 3,300 Unyvero cartridges, including controls and reproducibility tests performed at the different trial sites. In addition to local microbiology laboratory results and additional standardized central microbiology data from an independent reference laboratory, OpGen is currently generating next-generation sequencing data at its Rockville, MD, lab facility to also allow genotypic correlation of antibiotic resistance markers detected during the study. Based on the results of the unblinded data set, testing of additional contrived samples with well-characterized pathogen strains will complement and provide additional data points for low prevalence strains and antibiotic resistance markers. Based on all the data generated and analyzed, OpGen will now start preparing a De Novo request package for submission to the U.S. FDA in due course.
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WVE GSK | Hot Stocks07:34 EST Wave Life Sciences, GSK collaborate for oligonucleotide therapeutic development - Wave Life Sciences Ltd. (WVE) and GSK (GSK) announced a strategic collaboration to advance oligonucleotide therapeutics, including Wave's preclinical RNA editing program targeting alpha-1 antitrypsin deficiency, WVE-006. The discovery collaboration has an initial four-year research term. It combines GSK's unique insights from human genetics, as well as its global development and commercial capabilities, with Wave's proprietary discovery and drug development platform, PRISM(TM). Oligonucleotides are short strands of DNA or RNA that can reduce, restore, or modulate RNA through several different mechanisms. The unique capability of oligonucleotides to address a wide range of genomic targets in multiple therapeutic areas is enabling new opportunities to treat a range of human diseases, including diseases where no medicines currently exist or that have historically been difficult to treat with small molecules or biologics. Wave's PRISM platform is the only oligonucleotide platform offering three RNA-targeting modalities. Importantly, these modalities incorporate novel chemistry, including PN backbone chemistry and control of stereochemistry, to optimize the pharmacological properties of therapeutic oligonucleotides.The collaboration includes two main components. The first is a discovery collaboration which enables GSK to advance up to eight programs and Wave to advance up to three programs, leveraging Wave's PRISM platform and GSK's expertise in genetics and genomics. In addition to these programs, GSK receives the exclusive global license for Wave's preclinical program for AATD called WVE-006, which uses Wave's proprietary "AIMer" technology. AATD is an inherited genetic disease that affects both the lungs and liver with limited treatment options. Wave's WVE-006 is a first-in-class RNA editing therapeutic that is designed to address both liver and lung manifestations of the disease. Bepirovirsen, an investigational antisense oligonucleotide for the potential treatment of chronic hepatitis B infection, is now entering Phase III trials, and GSK4532990, a siRNA oligonucleotide, is progressing to Phase II for NASH. WVE-006 brings a third oligonucleotide into GSK's portfolio that has the potential to be a first-in-class AATD treatment for both lung and liver disease and is a well-understood genetic target, contributing to GSK's pipeline that is now more than 70% genetically validated. The companies expect to pursue targets across multiple disease areas, given preclinical data indicating Wave oligonucleotides can distribute to various tissues and cells without complex delivery vehicles.Under the terms of the agreement, Wave will receive an upfront payment of $170M, which includes a cash payment of $120M and a $50M equity investment. For the WVE-006 program, Wave is eligible to receive up to $225M in development and launch milestone payments and up to $300M in sales-related milestone payments, as well as tiered sales royalties. Development and commercialization responsibilities will transfer to GSK after Wave completes the first-in-patient study. For each of GSK's eight collaboration programs, Wave will be eligible to receive up to $130-$175M in development and launch milestones and $200M in sales-related milestones, along with tiered sales royalties. Wave will lead all preclinical research for GSK and Wave programs up to investigational new drug enabling studies. GSK collaboration programs will transfer to GSK for IND-enabling studies, clinical development, and commercialization. The collaboration includes an option to extend the research term for up to three additional years, expanding the number of programs available to both parties. The equity investment and collaboration agreement will complete at the same time and are conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.
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NYAX MA | Hot Stocks07:32 EST Nayax awarded MasterCard European issuer license - Nayax (NYAX) has received its European issuer license from Mastercard (MA), on behalf of CoinBridge. The European issuer license enables CoinBridge to further expand its operations and services into the EU and U.K. Together with receipt of an Israeli issuer license from Mastercard earlier this year, this reflects Nayax's strategy of obtaining issuer licenses across the globe and facilitating the launch of CoinBridge's "Pay with Points" loyalty solution across all regions. With this newly awarded license, CoinBridge intends to launch its payment services with European retailers in the coming months. CoinBridge is a solution for converting digital assets, including rewards, points, gift cards, vouchers, cashbacks and payouts, into real purchase transactions at any shop or website, worldwide, over the Credit Cards Scheme.
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DEN | Hot Stocks07:28 EST Denbury announces new CO2 sequestration site in SW Louisiana - Denbury announced a definitive agreement with a large landowner in southwest Louisiana for the future development and operation of a dedicated CO2 sequestration site. The 31,000 acre land position is located in Allen, Beauregard and Vernon Parishes, approximately 25 miles north of Denbury's Green Pipeline. Denbury estimates that there is potential to store up to 250 million metric tons of CO2 in the site, with first injection planned as early as 2026. The strategic location of the site provides nearby storage potential for the heavy industrial areas of Beaumont and Port Arthur, Texas, and Lake Charles, Louisiana. In close proximity to the dedicated CO2 sequestration site is more than 60 million metric tons per year of existing emissions. Nik Wood, Denbury's Senior Vice President, CCUS, commented, "Denbury has unparalleled experience and CO2 pipeline infrastructure in the U.S. Gulf Coast for the transportation and storage of CO2. Today's announcement adds an important piece in the development of our CCUS business, providing another significant future storage site in close proximity to our pipeline infrastructure, which naturally expands the reliability and future capacity of our network. We look forward to developing this site as we aim to provide the most efficient and reliable CO2 platform in the U.S."
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MRNA MRK | Hot Stocks07:25 EST Moderna, Merck says mRNA-4157/V940 met primary efficacy endpoint - Moderna, Inc. (MRNA) and Merck (MRK) announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA, Merck's anti-PD-1 therapy, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival versus KEYTRUDA alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection. Adjuvant treatment with mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared with KEYTRUDA alone. Adverse events observed with mRNA-4157/V940 in KEYNOTE-942 were consistent with those previously reported in a Phase 1 clinical trial. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies. Serious treatment-related adverse events occurred in 14.4% of patients who received the combination arm of mRNA-4157/V940 and KEYTRUDA versus 10% with KEYTRUDA alone. The companies plan to discuss the results with regulatory authorities and initiate a Phase 3 study in melanoma patients in 2023. In October of this year, the companies announced that Merck had exercised its option to jointly develop and commercialize mRNA-4157/V940. Merck and Moderna will share costs and any profits equally under this worldwide collaboration.
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JBLU | Hot Stocks07:25 EST JetBlue sees Q4 revenue per ASM at low end of 15%-19% range
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JBLU | Hot Stocks07:24 EST JetBlue sees Q4 CASM ex-fuel up 8.5%-10.5% year over three
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JBLU | Hot Stocks07:24 EST JetBlue still sees Q4 flown capacity up 1%-4% vs. 3Q19 - In a regulatory filing, JetBlue said its operational performance has remained strong with a solid completion factor quarter-to-date, including nearly 100% during the November holiday travel period. The company continues to expect flown capacity for the fourth quarter of 2022 to increase 1% to 4% compared to the third quarter of 2019. Underlying demand trends continue to be strong with healthy load factors and yields above 2019 levels for both trough and peak travel periods. JetBlue also continues to generate strong ancillary revenue performance, with exceptional co-brand performance which continues to reach record levels. However, JetBlue experienced a negative impact from Hurricane Nicole in November, and the expected very strong close-in demand for December reflected in its prior outlook has materialized below expectations. In addition, the adverse impact of the fourth quarter holiday calendar timing this year is greater than previously forecasted. As a result, JetBlue now expects revenue per available seat mile for the fourth quarter of 2022 to be at the low-end of its prior guidance range for a 15% to 19% increase. The company continues to expect CASM Ex-Fuel for the fourth quarter of 2022 to increase between 8.5% and 10.5%, year over three. Based on the forward curve as of December 9, 2022, JetBlue continues to expect an average all-in price per gallon of fuel of $3.65 in the fourth quarter of 2022.
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MRKR | Hot Stocks07:21 EST Marker, Lincoln Park enter into stock purchase agreement of up to $25M - Marker Therapeutics announced that the Company has entered into a Common Stock Purchase Agreement for up to $25M with Lincoln Park Capital Fund, LPC. Under the terms of the Agreement, LPC has committed to purchase up to $25M of shares of the Company's common stock at Marker's sole discretion from time to time during a 24-month period upon satisfaction of the conditions in the Agreement, including after a registration statement registering the resale of shares to be sold to Lincoln Park under the Purchase Agreement is declared effective by the Securities and Exchange Commission. The price per share is set forth in the Agreement and is generally based on the market prices prevailing at the time of each sale to LPC. Marker will retain full control as to the timing and amount of any sale of shares of common stock to LPC, subject to certain limitations specified in the Agreement, including those under Nasdaq listing rules. There is no upper limit as to the price per share that LPC may pay for future stock issuances under the Purchase Agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Marker's common stock. No warrants are being issued in this transaction, and the Agreement does not contain any rights of first refusal, participation rights, penalties or liquidated damages provisions in favor of any party.
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QNGY | Hot Stocks07:20 EST Quanergy initiates sale process through Chapter 11, CEO Kevin Kennedy to retire - Quanergy announced that the company initiated an orderly sale process for its business. To facilitate the sale and maximize value, the company filed for protection under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware and intends to pursue a sale of the business under section 363 of the Bankruptcy Code. Quanergy also announced that Kevin Kennedy, CEO, will retire effective December 31, but will continue to serve as non-executive chair of the board of directors. Kennedy will transition executive leadership to a newly appointed chief restructuring officer and president, Lawrence Perkins. Perkins is the founder and CEO of SierraConstellation Partners, an interim management and advisory firm, which he founded in 2013. Perkins has served in a variety of senior-level positions, including interim CEO/President, chief restructuring officer, board member, financial advisor, strategic consultant, and investment banker, to numerous private and public middle-market companies. Prior to the filing of the company's Chapter 11 case, the board of directors and management evaluated a wide range of strategic alternatives to maximize value for all stakeholders. The company also significantly reduced operating expenses and resolved significant patent litigation with Velodyne. Now with the protections afforded by the Bankruptcy Code, the company intends to broaden its marketing efforts to potential purchasers interested in specific business segments or assets as well as continuing to seek a going concern sale of the business. The company expects to continue operations during the Chapter 11 process and seeks to complete an expedited sale process with Bankruptcy Court approval. To help fund and protect its operations, Quanergy intends to use available cash on hand along with normal operating cash flows to fund post-petition operations and costs in the ordinary course.
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LEV | Hot Stocks07:20 EST Lion Electric announces pricing of marketed public offering of units - The Lion Electric Company announced the pricing of its previously announced marketed public offering of units in the United States and Canada. The Company will issue 19,685,040 Units at a price of $2.54 per Unit for aggregate gross proceeds to the Company of approximately $50M. Each Unit will consist of one common share in the capital of the Company and one common share purchase warrant. Each whole Warrant will entitle the holder thereof to acquire one common share in the capital of the Company at an exercise price of $2.80 per Warrant Share for a period of five years following the closing of the Offering. B. Riley Securities, Inc. and National Bank Financial Inc. are acting as joint bookrunners for the Offering. The Offering is expected to close on or about December 16, 2022, subject to customary closing conditions. Under the terms of the underwriting agreement, the Company has granted the Underwriters an over-allotment option, exercisable for a period of 30 days from the date of the closing of the Offering, to purchase up to 2,952,755 additional Units at a price of $2.54 per Unit, representing in the aggregate 15% of the total number of Units to be sold pursuant to the Offering. Power Sustainable Capital through its wholly-owned subsidiary Power Energy Corporation will purchase Units at the offering price representing an aggregate purchase price of approximately $25M. The Company intends to use the net proceeds of the Offering to strengthen its financial position, and allow it to continue to pursue its growth strategy, including the Company's capacity expansion projects in Joliet, Illinois and Mirabel, Quebec.
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IREN | Hot Stocks07:18 EST Iris Energy reports 151 bitcoin mined in November - Iris Energy published a monthly investor update for November 2022, containing its results from operations as well as construction and development updates. Corporate: Liquidity: $47 million cash, no debt; $21 million estimated net capex spend to achieve 180MW5; $75 million remaining Bitmain prepayments; $100 million unutilized under B. Riley equity facility; Potential monetization of assets through miner sales. Opportunities: Significant optionality from 180MW real assets platform; Focus on expanding self-mining capacity to 5.4 EH/s; Potential additional expansion from 20MW to 600MW at Childress. On November 21, the Company also provided a corporate update and announced certain preliminary financial information and operational updates for Q1 FY23 and October 2022. Operations: Average operating hashrate of 1,445 PH/s; Monthly operating revenue of $2.9 million; 151 Bitcoin mined.
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TBCRF | Hot Stocks07:17 EST Timbercreek Financial comments on Groupe Selection loans - Timbercreek Financial provided commentary and clarification on its loans to Groupe Selection. On November 13, 2022, Groupe Selection filed an application under the Companies' Creditors Arrangement Act in order to proceed with a restructuring. Several recent media articles have stated that Timbercreek's investments to Groupe Selection total approximately $212M. Timbercreek is in the business of originating commercial mortgages and often works with third-party lenders to share loans based on different risk and return criteria. This total amount represents the gross amount of the first ranking registered and secured hypothecs on two investments in Quebec: an apartment construction loan of $81.6M and a retirement home loan of $130M. Net of syndicated amounts, Timbercreek Financial's total commitment to Groupe Selection is $78.1M. This includes $13.1M on the apartment construction project that is approximately 60% complete and $65M on a high-quality operating retirement home in Montreal. As at September 30, 2022, Timbercreek Financial's net mortgage investments were $1,255.4M. Timbercreek Financial is actively representing itself and its syndication partners legally and is closely involved in the current proceedings before the courts. The Company has legal options as a first ranking secured creditor and will continue to act in the best interest of shareholders, including potentially seeking to lift the CCAA stay in order to enforce its security against these two projects. The Company has considerable experience in these situations and will work towards a successful resolution of these investments. Blair Tamblyn, CEO of Timbercreek Financial, said: "While we do not typically comment on individual loans, we felt it was important to clarify our net exposure in this circumstance. Having originated more than $13B in commercial real estate debt since launching our lending platform in 2007, and actively managed a sizable portfolio through multiple economic cycles, we are experienced in navigating these kinds of situations to preserve our investors' principal."
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MRNA MRK | Hot Stocks07:17 EST Moderna, Merck report personalized mRNA cancer vaccine trial met trial endpoint - Moderna (MRNA) and Merck (MRK) announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda, Merck's anti-PD-1 therapy, demonstrated a "statistically significant and clinically meaningful" improvement in the primary endpoint of recurrence-free survival, or RFS, versus Keytruda alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection. Adjuvant treatment with mRNA-4157/V940 in combination with Keytruda reduced the risk of recurrence or death by 44% compared with Keytruda alone. Adverse events observed with mRNA-4157/V940 in KEYNOTE-942 were consistent with those previously reported in a Phase 1 clinical trial. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies. Serious treatment-related adverse events occurred in 14.4% of patients who received the combination arm of mRNA-4157/V940 and KEYTRUDA versus 10% with KEYTRUDA alone. The companies plan to discuss the results with regulatory authorities and initiate a Phase 3 study in melanoma patients in 2023. In October of this year, the companies announced that Merck had exercised its option to jointly develop and commercialize mRNA-4157/V940. Merck and Moderna will share costs and any profits equally under this worldwide collaboration. "Today's results are highly encouraging for the field of cancer treatment. mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma. We will begin additional studies in melanoma and other forms of cancer with the goal of bringing truly individualized cancer treatments to patients. We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as with health authorities," said Stephane Bancel, Moderna's CEO.
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GRTS | Hot Stocks07:16 EST Gritstone granted two new U.S. patents for samRNA - Gritstone bio announced that the United States Patent and Trademark Office, USPTO, recently issued two new patents related to the company's novel self-amplifying mRNA, samRNA, vaccine platform technology. U.S. Patent No. 11,504,421 includes claims covering Gritstone's individualized cancer vaccine candidates. U.S. Patent No. 11,510,973 includes claims covering antigen-encoding samRNA vectors and has broad applicability across Gritstone's candidates in oncology and infectious disease. "Self-amplifying mRNA is increasingly being recognized for its benefits over first-generation mRNA, and our new patents reflect the leadership position we believe we have established in this rapidly growing space," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone. "Gritstone's samRNA vectors enable extended duration and magnitude of antigen expression, in an immunostimulatory context, which together can drive more potent and durable induction of neutralizing antibodies and T cell immunity. In addition, Gritstone's samRNA vectors allow for large cassettes, providing substantial target antigen capacity and flexibility. The clinical data we have shared to date support the potential broad application and powerful impact of this technology, and we look forward to harnessing these inherent capabilities as we further advance and develop samRNA therapeutics and prophylactics for oncology and infectious diseases."
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MCIOF | Hot Stocks07:15 EST MCI Onehealth announces consolidation of certain Ontario clinics - MCI Onehealth Technologies announced that it is consolidating certain Ontario clinics within its high-performance healthcare network. The consolidation is expected to enable extended hours at remaining clinics, enable intensification of services and significantly reduce overhead costs. Consolidated MCI clinics will cease operations under MCI management in the Company's fourth quarter of 2022, with the majority of physicians, nurses and staff expected to be redeployed at remaining MCI clinics. Ontario and Alberta clinics that operate as MCI The Doctor's Office will continue to provide top-quality, accessible walk-in, family practice and specialist care to MCI's clientele of more than one million patients. The five MCI The Doctor's Office clinics in Alberta are not participating in the consolidation. "MCI has made the strategic decision to consolidate five under-capacity clinics into its remaining 15 Ontario clinics where possible. We fully expect that this action will have a positive impact on the financial performance of the Company and enable the Company to remain focused on sustained growth in its higher-margin, data-driven and clinical research initiatives." said Scott Nirenberski, MCI Onehealth CFO.
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GTBIF | Hot Stocks07:13 EST Green Thumb names Anthony Georgiadis president, Matt Faulkner CFO - Green Thumb Industries announced the appointments of four executive leadership positions and one new board member. The leadership promotions include Anthony Georgiadis to President, Matt Faulkner to Chief Financial Officer, and Bret Kravitz to General Counsel and Secretary, as well as the appointments of Rachel Albert to Chief Administrative Officer and Dawn Wilson Barnes to the Company's board of directors. These appointments will be effective January 1, 2023. As President, Georgiadis will be responsible for all operational and financial matters of the Company. His direct reports will include CFO General Counsel, and Senior Vice Presidents who oversee operational functions. Georgiadis will continue to work closely with Kovler on overall corporate strategy and operations, while allowing Kovler to focus greater attention on capital allocation, strategic partnerships, brand positioning, investor relations, and mergers & acquisitions. Since 2017, he has served as CFO, directing the Company's cash flow and financial planning while overseeing operations for other areas of the business. As Chief Financial Officer, Faulkner will be responsible for managing all financial activities for the Company. Faulkner joined Green Thumb in 2018 and was appointed to Chief Accounting Officer in 2020. As General Counsel and Secretary, Kravitz will serve as the primary legal advisor to management and the board while overseeing all legal matters of the Company. Kravitz has served as Chief Corporate Counsel since joining Green Thumb in 2017. Rachel Albert will assume a new role as Chief Administrative Officer, supporting executive initiatives and decision-making while helping to shape Green Thumb's culture. Albert joined Green Thumb as a consultant in 2020 to lead the Human Resources department. The Company also announced the appointment of Dawn Wilson Barnes to its board of directors effective January 1, 2023. Barnes will join the board as an independent director and member of the audit committee. Barnes is an experienced financial services professional, and currently serves as President and Founder of Aurora Bay Capital.
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FLNC | Hot Stocks07:12 EST Fluence Energy to design, manufacture battery packs as part of storage products - Fluence Energy announced a strategic plan to develop Fluence-made battery packs, with production set to begin in early 2024 in the United States. The move is intended to give Fluence greater control over the global supply chain and increase standardization across products. The Fluence-designed pack will include battery modules and a battery management system with cells procured competitively from our growing base of global suppliers. "This strategic move to develop the Fluence battery pack is possible because of the deep technical expertise within our research and development team," said Fluence SVP and Chief Product Officer Rebecca Boll. "This program is the next pivotal step for Fluence's supply chain flexibility. The Fluence-developed BMS allows for the rapid acceleration of our cloud-based software products and aftermarket services growth, all while providing increased standardization across our storage products." Fluence is working closely with suppliers to secure a globally-diversified battery cell supply and will procure cells competitively for our battery packs. Fluence will also incorporate its own BMS technology into the packs to enhance access to granular data and system control, while expanding battery intelligence capabilities.
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LAD | Hot Stocks07:12 EST Lithia & Driveway purchases first location in Kentucky - Lithia & Driveway has purchased its first location in Kentucky. The store is projected to generate more than $140M in annualized revenue. In 2022, LAD has acquired 33 stores that are expected to contribute annualized revenue of $3.5B. Acquisitions continue to be a key part of the company's 2025 plan to reach $50B in revenue and $55-$60 in EPS.
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FRGT | Hot Stocks07:10 EST Freight Technologies' platform Fr8App integrates with FourKites - Freight Technologies discloses its integration with FourKites, a leading supply chain visibility platform in the U.S. With this integration, Fr8App's platform can send automatic locations to the FourKites's New Unified Customer Interface so that enterprise companies using the new FourKites's product are able to receive real time locations from drivers using Fr8App. "A leader in track and trace in the U.S., FourKites is used by many enterprise companies and some of our current customers. With this integration we empower our Fr8Radar product, making the track and trace monitoring process more efficient for our customers currently using FourKites's monitoring system," said Javier Selgas, CEO of Fr8Tech. "By integrating with Fr8App, FourKites has validated our services and increased our access to new, large customers. We believe this alliance will be a long-term revenue driver and we look forward to reporting on our progress."
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PMGM AEON | Hot Stocks07:10 EST Priveterra Acquisition, AEON Biopharma enter business combination agreement - AEON Biopharma and Priveterra Acquisition announced that they have entered into a definitive business combination agreement. Upon closing of the proposed transaction, the combined company will operate as AEON Biopharma, Inc. and is expected to list on Nasdaq under the ticker symbol "AEON". The companies said, "Since its founding in 2019, AEON Biopharma has been led by Marc Forth, an Allergan plc veteran of 16 years and a former head of the BOTOX Therapeutic franchise in the United States. AEON has assembled a seasoned team with expertise in neuroscience research, development, regulatory affairs, operations, manufacturing, and commercialization. Its executive team is comprised of industry leaders who have led new drug FDA approvals including multiple indications across multiple neurotoxin products. The global therapeutic neurotoxin market is currently estimated to be $3.0 billion, of which the U.S. represents approximately 84%, and projected to grow to approximately $4.4 billion in 2027. BOTOX, marketed by Abbvie, Inc., currently holds approximately 95% U.S. market share for therapeutic indications in the neurotoxin space.1 Other neurotoxin competitors have had success with aesthetic indications in the cash-pay consumer-driven market but have been unable to acquire meaningful market share for therapeutic indications due to the indirect influence of pricing dynamics for aesthetic indications that results in a minimal value proposition for both payors and providers. AEON intends to file a unique BLA for therapeutic indications that would be free of any effects on reimbursement that exist for all other toxin competitors that have both therapeutic and aesthetic indications approved under a single BLA. Lead product candidate, ABP-450, is the same botulinum toxin approved and marketed for an aesthetic indication. Its 900 kDa molecular weight, similar to the market leader, will enable providers with a seamless transition to ABP-450 for therapeutic uses. Similar to the approved neurotoxins currently in the market, ABP-450's commercial success does not depend upon patent protection, creating the possibility for an annuity-like construct of continued revenue generation, should ABP-450 be FDA approved. AEON's therapeutic-only focus also provides a differentiated business model designed to deliver enhanced value to payors and providers by permitting a traditional pharma pricing model that is not currently available to competitors that also market their products for aesthetic uses approved under a single BLA. The sole focus on therapeutics allows AEON to pursue an original BLA filing that would allow a unique commercial strategy that cannot be employed by other competitors." Priveterra will acquire 100% of AEON in exchange for the issuance of 16.5 million of shares of common stock of Priveterra to the existing shareholders and convertible noteholders of AEON at close. Priveterra's sponsor has also allocated 50% of its common stock to an earnout based on achievement of certain clinical milestones. The Boards of Directors of both AEON and Priveterra have unanimously approved the proposed merger, which is expected to close in the first half of 2023, subject to the approval by Priveterra's shareholders and the satisfaction or waiver of certain other customary closing conditions.
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HIW | Hot Stocks07:09 EST Highwoods Properties, The Bromley Companies form 50/50 joint venture - Highwoods Properties and The Bromley Companies have formed a 50/50 joint venture to construct Midtown East, a multi-customer office development project located in the mixed-use Midtown Tampa project in Tampa's Westshore submarket. Upon completion, the joint venture will own 134,000 square feet, consisting of five floors of office and ground level retail, of an overall 18-story, 432,000 square foot tower. The total anticipated investment for the joint venture's share of the overall project is approximately $83M. Construction of the project is expected to begin in the first quarter of 2023 with a scheduled completion date in the first quarter of 2025 and a pro forma stabilization date in the second quarter of 2026. Highwoods currently owns an 80% interest in a joint venture with The Bromley Companies that developed and owns Midtown West, a 150,000 square foot, $71 million office project completed in the second quarter of 2021 that was 92.5% leased as of September 30, 2022. Ted Klinck, President and Chief Executive Officer of Highwoods, said, "We're excited to once again partner with The Bromley Companies on another high-quality office development in the dynamic Midtown Tampa district. The proven success of Midtown West, which broke ground in the fourth quarter of 2019 and leased up according to pro forma even in the midst of a global pandemic, has demonstrated how quickly Midtown Tampa has become the premier office destination for growing companies in Tampa."
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IMV | Hot Stocks07:08 EST IMV begins trading on the TSX and Nasdaq post-reverse stock split - IMV announced that its common shares commence trading post consolidation . As announced and previously approved by shareholders on December 7, the Corporation has consolidated its outstanding common shares on the basis of one new common share for every 10 outstanding common shares. The consolidation has taken effect on December 7, and the Corporation's common shares commence trading on the Toronto Stock Exchange and on the Nasdaq Capital Market under the name IMV Inc. on a post-consolidation basis at the opening of markets today. The consolidation is primarily intended to bring the Corporation into compliance with the minimum required closing bid price for continued listing on Nasdaq of US$1.00 per share.
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TAK | Hot Stocks07:07 EST Takeda to acquire NDI-034858 from Nimbus Therapeutics for $4B upfront - Takeda announced that it will acquire NDI-034858 from Nimbus Therapeutics. NDI-034858 is an oral, selective allosteric tyrosine kinase 2, or TYK2, inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis. When the transaction is complete, NDI-034858 will be known as TAK-279. Nimbus recently disclosed positive topline results from a Phase 2b study evaluating NDI-034858 in patients with moderate-to-severe plaque psoriasis. Takeda intends to present results from this Phase 2b study early in 2023. NDI-034858 is anticipated to enter Phase 3 in psoriasis in 2023. It is in an ongoing Phase 2b study in active psoriatic arthritis, and Takeda plans to investigate it for the treatment of IBD and other autoimmune diseases. Under the terms of the agreement, Takeda will pay Nimbus $4B upfront, and two milestone payments of $1B each upon achieving annual net sales of $4B and $5B. The upfront payment will be primarily funded by cash on hand. The transaction is expected to be finalized before the end of FY22. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
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FUV | Hot Stocks07:07 EST Arcimoto announces development of driverless EVs for tourism rentals - Arcimoto announced a partnership with Faction Technology, Inc. and GoCar Tours, Inc. to develop up to 310 driverless electric vehicles, powered by Faction's DriveLink and TeleAssist technologies and GoCar's patented GoCar Network technology, which allows users to explore select cities on their own schedule at their own pace. The partnership calls for an initial 20-vehicle pilot program to begin at GoCar Tours Las Vegas in 2023. Upon successful completion of the pilot, GoCar will begin a phased deployment of up to an additional 290 vehicles to GoCar locations in Las Vegas, San Francisco, and San Diego, Calif., and later in Barcelona, Spain. "This is a confluence of three cutting-edge technologies: the rightsized Arcimoto electric vehicle architecture, Faction's driverless technology, and GoCar's award-winning GPS-guided tours," said Jesse Fittipaldi, Arcimoto Interim CEO. "Building on GoCar's proven business model, we believe this is a perfect fit for the sustainable tourism industry today, and will be a key step in our plans to deploy driverless FUVs for everyday transportation in the future." Faction's DriveLink and TeleAssist technologies will enable GoCar EVs to combine autonomy with remote human teleoperation.
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BLCO | Hot Stocks07:05 EST Bausch + Lomb's Biotrue contact lense cleaner receives 510(k) clearance from FDA - Bausch + Lomb has received 510(k) clearance from the FDA for Biotrue Hydration Boost Contact Lens Rehydrating drops, a preservative-free multi-dose rehydrating drop for use with soft and rigid gas permeable contact lenses. Biotrue Hydration Boost Contact Lens drops contain a combination of ingredients informed by the Tear Film and Ocular Surface Society's DEWS II report including hyaluronan, a moisturizer found naturally in the eye, and other naturally inspired ingredients. Biotrue Hydration Boost for Contacts also matches the pH of healthy tears for comfort.
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WBX LYFT | Hot Stocks07:05 EST Wallbox and Lyft team to boost home EV charging access in North America - Drivers on the Lyft (LYFT) platform in the United States and Canada can now purchase Level 2 home EV chargers through Wallbox (WBX) and installation services performed by COIL, a recent Wallbox acquisition. The partnership gives Lyft drivers a discount on L2 EV chargers from Wallbox. This is the first such partnership between Wallbox and Lyft and highlights the commitment of both companies to lower barriers to EV ownership in North America. Earlier this year, Consumer Reports released the results of a survey that found 71% of Americans have some level of interest in owning or leasing an EV. The same survey found that "charging logistics" was cited as the top barrier to entry among respondents. "We're excited to partner with Lyft to make access to EV charging easier for drivers across North America," said Douglas Alfaro, General Manager of Wallbox North America. "Wallbox is committed to doing our part in making the path to EV ownership easier for consumers, and our partnership with Lyft represents a significant step forward on that mission."
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EVGO LYFT | Hot Stocks07:05 EST EVgo, Lyft launch new partnership to accelerate rideshare electrification - EVgo (EVGO) announced the launch of a new EV charging discount program for rideshare drivers on the Lyft (LYFT) platform. Starting this week, drivers on the Lyft platform will be able to enroll in the new program with EVgo via the Lyft Driver app. Once enrolled, drivers in certain markets with Lyft Gold and Platinum status can save up to 45% on session costs over EVgo's standard Pay As You Go rates. In addition, drivers with Lyft will enjoy waived monthly fees at EVgo's more than 850 fast charging locations nationwide.
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ADMA | Hot Stocks07:04 EST ADMA Biologics announces FDA approval for storage of ASCENIV, BIVIGAM - ADMA Biologics announced the United States Food and Drug Administration's, FDA, approval for its supplemental Biologics License Applications, BLAs, for both ASCENIV and BIVIGAM to now include room temperature storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM. "With today's announced approval, the Company anticipates reaching more customers otherwise inaccessible due to limited refrigeration space and cold chain capacity constraints; this approval meaningfully alleviates these supply chain restrictions," said Adam Grossman, President and Chief Executive Officer of ADMA. "The approval of room temperature storage for ASCENIV and BIVIGAM is a meaningful enhancement of each product's go-to market offering as it should provide for more versatile utilization and inventory management by providers."
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CYTK | Hot Stocks07:03 EST Cytokinetics announces Nasdaq halts trading of stock - Cytokinetics, Incorporated announced that Nasdaq has halted the trading of the Company's common stock. The U.S. Food & Drug Administration Cardiovascular and Renal Drugs Advisory Committee is meeting to review the New Drug Application for omecamtiv mecarbil, an investigational selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction. The advisory committee meeting, which is being held virtually, is scheduled to begin at 9:00 AM.The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA. The NDA for omecamtiv mecarbil is based on the results from GALACTIC-HF, the Phase 3 clinical trial of omecamtiv mecarbil. The Prescription Drug User Fee Act target action date for the NDA is February 28, 2023.
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AAL | Hot Stocks07:03 EST American Airlines names Devon May Chief Financial Officer - American Airlines Group announced that Devon May has been named Chief Financial Officer following a long-planned succession process. May, who is currently the airline's senior vice president of Finance and Investor Relations, will assume the CFO role effective Jan. 1, 2023. He will report to American's CEO Robert Isom. American's current CFO Derek Kerr will remain at the airline as Vice Chair, President of American Eagle and Strategic Advisor. He will continue to lead American's Regional and Cargo teams and serve as a strategic advisor to the company.
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AIRS | Hot Stocks07:02 EST AirSculpt Technologies to open London location in 2023 - AirSculpt Technologies announced the opening of its first overseas Elite Body Sculpture location in London, England in the first half of 2023. AirSculpt now expects to open five office locations in 2023.
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SVRE | Hot Stocks07:02 EST SaverOne 2014 receives expanded order for 25 cement trucks from ReadyMix - SaverOne 2014 announced that following an initial successful trial earlier this year among a small group of trucks, SaverOne has received an expanded order for a further 25 cement trucks from ReadyMix Industries. ReadyMix and its parent company, Cemex Group, a global leader in the building materials industry, both present significant potential for SaverOne, with fleets of hundreds of cement mixer trucks and heavy vehicles.
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TRU | Hot Stocks06:47 EST TransUnion to sell G2, LCI and Fintellix for $176M - TransUnion has signed a definitive agreement to sell G2 Web Services, Lundquist Consulting - LCI - and Fintellix India, to an affiliate of Stellex Capital, a global, multi sector investment firm with offices in New York, Detroit, Pittsburgh and London with over $2.6B in AUM. The $176M consideration consists of $104M of cash and a $72M note receivable with up to three years in duration. The companies are targeting to close the transaction by the end of the year. TransUnion expects to use the net cash proceeds to pre-pay debt. TransUnion acquired Verisk Financial Services in April 2022 for $515M for its proprietary database of card and deposit transactions, and related advisory services.
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QTRHF | Hot Stocks06:35 EST Quarterhill announces C$80M contract with ETC - Quarterhill announced that the Alameda County Transportation Commission has signed a contract with Electronic Transaction Consultants, or ETC, a Quarterhill company, for the implementation and operation of the electronic toll system integration services for the I-680 Express Lanes. Alameda CTC is the managing agency for the I-680 Express Lanes on behalf of the I-680 Sunol Smart Carpool Lane Joint Powers Authority. The initial term of the contract is 10 years with options for up to four additional years of operations and maintenance. Excluding option years, the base contract is valued at approximately C$80M.
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UAL BA | Hot Stocks06:33 EST United orders 100 Boeing 787 Dreamliners, includes option to purchase 100 more - United Airlines (UAL) announced the largest widebody order by a U.S. carrier in commercial aviation history: 100 Boeing (BA) 787 Dreamliners with options to purchase 100 more. United expects to take delivery of the new widebody planes between 2024 and 2032 and can choose among the 787-8, 9 or 10 models, providing flexibility to support a wide range of routes. United also exercised options to purchase 44 Boeing 737 MAX aircraft for delivery between 2024 and 2026 - consistent with the United Next 2026 capacity plan - and ordered 56 more MAX aircraft for delivery between 2027 and 2028. The airline now expects to take delivery of about 700 new narrow and widebody aircraft by the end of 2032, including an average of more than two every week in 2023 and more than three every week in 2024. United also will retrofit 100% of its mainline, narrow-body planes with its signature interior - about 100 aircraft are scheduled to be completed in 2023 with the remaining expected to be completed by the end of 2025. Approximately 100 planes of the new widebody order are expected to replace older Boeing 767 and Boeing 777 aircraft, with all 767 aircraft removed from the United fleet by 2030, resulting in up to an expected 25% decrease in carbon emissions per seat for the new planes compared to the older planes they are expected to replace.
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TNDM | Hot Stocks06:32 EST Tandem Diabetes to acquire AMF Medical - Tandem Diabetes announced that it has entered into a definitive agreement to acquire AMF Medical SA, the privately held Swiss developer of the Sigi Patch Pump. The Sigi Patch Pump is under development and not commercially available. It is designed to be an ergonomic, rechargeable patch pump that reduces the burden of managing diabetes through its use of pre-filled insulin cartridges and its compatibility with automated insulin delivery technology. Tandem Diabetes Care will acquire AMF Medical under the following financial terms of the agreement: A previous strategic investment of CHF 8M paid in the third quarter of 2022; A cash payment of CHF 62.4M due at closing; Additional contingent earnout payments of up to CHF 129.6M, in aggregate, payable upon the achievement of certain milestones, including: Up to CHF 38.4M upon the successful completion of key development milestones over the next two years; Up to CHF 91.2M upon obtaining regulatory clearance of an automated controller enabled pump by the United States FDA. The transaction is subject to the satisfaction of customary closing conditions and is expected to close in January 2023.
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BW | Hot Stocks06:32 EST Babcock & Wilcox awarded $20M contract for ash-handling technologies - Babcock & Wilcox's B&W Environmental segment has been awarded a contract for more than $20M to design and supply ash-handling and conveying technologies for a power plant in North America. The equipment is designed to assist the plant operator to reduce the environmental impact of the plant and compliance with emissions regulations. The SGC systems will be manufactured in B&W's Lancaster, Ohio, facility.
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LZM GOGN | Hot Stocks06:14 EST GoGreen Investments enters into business combination with Lifezone Metals - GoGreen Investments (GOGN) has entered into a definitive agreement for a business combination with Lifezone Metals, a developer of cleaner battery metals. The transaction will create the first nickel resource and green technology company listed on the NYSE. Upon completion of the proposed transaction, the combined company will operate under the "Lifezone Metals" name and be listed on the NYSE under the ticker symbol "LZM". Lifezone Metals pairs one of the largest and highest-grade undeveloped nickel sulphide deposits in the world with proprietary green-processing technology, to produce cleaner metals in support of growing demand for batteries used in electric vehicles, fuel cell vehicles and energy storage. The transaction values the combined company at a pro forma implied equity value of approximately $1.0B with total net proceeds of $318M. Including the net proceeds from the transaction and existing cash on Lifezone's balance sheet, Lifezone would have over $357M of cash at transaction close, which is expected to help fund the company's future growth and transition into its commercialization phase in 2026. Concurrently with the consummation of the transaction, new strategic and institutional investors have committed in excess of $70M in a common equity PIPE at $10 per share, with additional commitments subject to agreement. Chris Showalter, CEO of Lifezone, will continue as CEO. Keith Liddell, founder of Lifezone, will serve as the Chairman of the Lifezone Metals Board, and Michael Sedoy, CFO of GoGreen, will join Lifezone Metals as interim CFO. John Dowd, GoGreen CEO and Govind Friedland, GoGreen COO, will join the Lifezone Metals Board. The balance of the Lifezone Metals Board members will be appointed by Lifezone.
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SECO | Hot Stocks06:08 EST Secoo Holding regains compliance with Nasdaq minimum bid price requirement - Secoo Holding has received a written notification letter from the Listing Qualifications Department of Nasdaq dated December 12 informing the company that it has regained compliance with Nasdaq's Minimum Bid Price Requirement. The closing bid price of the company's ADSs has been at $1.00 per ADS or greater for 10 consecutive business days from November 28 to December 9, and the matter is closed.
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HITI | Hot Stocks06:07 EST High Tide begins selling cannabis seeds in the United States - High Tide announced that it has begun selling cannabis seeds in the United States, initially through its wholly owned subsidiaries Grasscity and Smoke Cartel, which are the two most popular e-commerce platforms for consumption accessories in the world. The company plans to expand seed sales to additional online retail platforms within its portfolio in 2023.3 This launch comes on the heels of the American Drug Enforcement Agency's recent official determination that cannabis seeds fall under the legal definition of hemp and can therefore be sold openly in the United States.
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RMTI | Hot Stocks06:06 EST Rockwell Medical adds hemodialysis business in Minnesota - Rockwell Medical is adding new business within the Minnesota region. Rockwell started to supply these clinics with its hemodialysis concentrates products effective December 5, anticipates that all clinics will be onboarded by January 1, 2023, and expects to generate over $1M in revenue the first year. In the U.S., the in-center hemodialysis concentrates market is currently valued at $380M and is anticipated to grow to approximately $500M by 2026, driven primarily by an increasing number of patients suffering from end-stage kidney disease. Rockwell believes it is well-positioned to achieve annual revenue of $100M in the next few years.
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AXNX | Hot Stocks06:06 EST Axonics announces Health Canada approval of R20 neurostimulator - Axonics announced that Health Canada has approved the company's fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to once every 6 to 10 months for only one hour. This compares to the third-generation's recharging interval of once a month for one hour. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the third-generation device and is paired with the same tined lead and intuitive, easy to use patient remote control. Axonics has commenced sales of the R20 sacral neuromodulation system to customers in Canada. The device is currently under review by the FDA in the United States. The company anticipates FDA approval and plans to commercially launch the product in the United States in the first quarter of 2023.
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WPRT | Hot Stocks06:03 EST Westport, Johnson Matthey announce collaboration - Westport Fuel Systems announced their collaboration with Johnson Matthey to develop an emissions aftertreatment system tailored to Westport's proprietary H2 HPDI hydrogen fuel system, with the goal of reducing or eliminating emissions. The agreement focuses on combining Johnson Matthey's technologies and products with Westport's H2 HPDI fuel system to create the lowest possible vehicle tailpipe emissions. In collaboration with Johnson Matthey, Westport will test and develop the Johnson Matthey prototype system at the company's engineering center in Vancouver, Canada.
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GGR | Hot Stocks06:02 EST Gogoro announces four year extension of Taiwan subsidy program - Gogoro announced its support for the Taiwan government's decision to extend its electric two-wheel vehicle subsidy program for four additional years.
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LL | Hot Stocks06:02 EST LL Flooring expects to open three to four new stores in 2023 - LL Flooring provided a business update in advance of investor meetings, noting the company's plans to slow new store openings and recommence share repurchases in 2023 under its existing share repurchase program. "We are confident in our long-term growth strategies and our unique positioning of offering the high-touch service of an independent combined with the value and convenience of a national brand," said President and CEO Charles Tyson. "In light of the current macroeconomic environment, we believe it is prudent to slow our new store opening cadence and allocate capital toward share repurchases under our current authorized plan." The company recently opened two new stores in Bellingham, Washington, and Joplin, Missouri, bringing total new store openings to 18 in 2022. Looking ahead to 2023, the company currently expects to open three to four new stores. The company will continue to evaluate its new store opening strategy based on the operating environment.
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IBM | Hot Stocks05:30 EST IBM, Rapidus announce joint development pact ro advance logic scaling in Japan - IBM and Rapidus announced a joint development partnership to advance logic scaling technology as part of Japan's initiatives to become a leader in semiconductor research, development, and manufacturing. IBM and Rapidus announced a joint development partnership to advance logic scaling technology as part of Japan's initiatives to become a global leader in semiconductor research, development, and manufacturing.
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GLPG | Hot Stocks05:26 EST Galapagos, CellPoint present initial data from ongoing ATALANTA-1 study - Galapagos and CellPoint presented initial data from the ongoing ATALANTA-1 Phase 1/2 study with GLPG5101 at the 64th Annual American Society of Hematology, or ASH, Congress taking place in New Orleans, Louisiana. ATALANTA-1 is a Phase 1/2 study in heavily pre-treated rrNHL patients to evaluate the safety, efficacy, and feasibility of GLPG5101, a fresh CD19 CAR-T product candidate manufactured at point-of-care. The dose levels that are evaluated in the Phase 1 part of the study are 50x106, 110x106 and 250x106. As of November 8, 9 patients were enrolled; baseline and safety data for eight patients were available. Seven patients reached the follow-up period of 28-days and were eligible for efficacy evaluation. The initial results from seven patients that were eligible for efficacy evaluation indicated that a seven-day vein-to-vein time is feasible and demonstrated strong and consistent in vivo CAR-T expansion levels. Moreover, the initial efficacy results are encouraging with an objective response rate, or ORR, of 86% observed and all responding patients achieving a complete response, or CR. A duration of response of up to seven months has been reported and follow-up is ongoing. Two patients who received DL1 that progressed after initial stable disease or CR respectively, had a CD19-negative escape. No CD19-positive relapses have been observed. In the safety analysis of these seven patients, adverse events were consistent with the known toxicities of CD19 CAR-T treatment. No grade 3 or higher cytokine release syndrome, or CRS, or immune effector cell-associated neurotoxicity syndrome, or ICANS, was observed in any of the patients. At DL2, CRS grade 1 or 2 was reported in 4 patients and ICANS grade 1 was reported in three patients. Patients at DL1 did not experience any grade of CRS or ICANS. Dose-limiting toxicity was observed in 1 patient and the majority of grade 3 adverse events were hematological toxicities.
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MIRM | Hot Stocks05:19 EST Mirum Pharmaceuticals announces EC marketing authorization for Livmarli - Mirum Pharmaceuticals announced that the European Commission has granted marketing authorization for Livmarli oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome, or ALGS, two months of age and older. The approval follows a positive opinion granted by the European Committee for Medicinal Products for Human Use, or CHMP, in September. LIivmarli is the first and only approved treatment in both the European Union and the United States to treat this rare liver disease affecting one out of 30,000 people globally.
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EQIX | Hot Stocks05:18 EST Equinix to enter South African market with $160M data center investment - Equinix announced plans to enter the South African market with a $160M data center investment in Johannesburg that augments its current footprint on the African continent in Nigeria, Ghana and Cote d'Ivoire. The new data center is expected to open mid-2024. With its South Africa expansion, Equinix is entering one of the largest and most digitally developed nations on the African continent.
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CALT VTRS | Hot Stocks05:16 EST Calliditas Therapeutics enters exclusive Nefecon license agreement with Viatris - Calliditas Therapeutics (CALT) announced that they have entered into an exclusive license agreement with Viatris (VTRS), to register and commercialize Nefecon, a specialty drug recently approved in Europe and the U.S. for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy, or IgAN, in Japan. Under the terms of the agreement, Calliditas is entitled receive an initial upfront payment of $20M upon signing and up to an additional $80M in pre-defined development and commercialization milestones. Viatris will also pay mid-teens percentage royalties on net sales. IgAN, also known as Berger's disease, is a rare and serious progressive autoimmune disease in which up to 50% of patients end up at risk of developing end stage renal disease and thus requiring dialysis or a kidney transplant.
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GFI | Hot Stocks05:14 EST Gold Fields CEO Chris Griffith to step down - Gold Fields has announced that Chris Griffith will step down from the board of directors and as CEO of Gold Fields, effective December 31.
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QGEN | Hot Stocks05:09 EST Qiagen announces FDA approval of therascreen KRAS RGQ PCR kit as companion test - Qiagen has announced the FDA approval of its therascreen KRAS RGQ PCR kit as a companion diagnostic test to Mirati Therapeutic's drug Krazati for non-small cell lung cancer, or NSCLC. Qiagen and Mirati Therapeutics (MRTX), a targeted oncology company, announced their cooperation in May 2021. The tissue based KRAS companion diagnostic assay, which Qiagen developed specifically to identify patients with NSCLC that have a KRAS G12C mutation, is instrumental in determining who may benefit from treatment with KRAZATI. The drug is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA approved test, who have received at least one prior systemic therapy.
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IMGN | Hot Stocks05:06 EST ImmunoGen enters exploratory research collaboration with Biosion for ADCs - Biosion announced an exploratory research collaboration to create antibody-drug conjugates, or ADCs, for the treatment of cancer with ImmunoGen (IMGN). In the joint research effort, Biosion will leverage its proprietary SynTracer high-throughput, or HT, endocytosis platform to generate highly selective antibodies to targets allocated by each company and ImmunoGen will provide their proprietary linker-payload technology to create novel ADCs.
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