Stockwinners Market Radar for September 26, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
DINO | Hot Stocks20:24 EDT HF Sinclair exec sells $2.84M in common stock - In a regulatory filing, HF Sinclair disclosed that its EVP Michael Jennings sold 50K shares of common stock on September 26th in a total transaction size of $2.84M.
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PATH | Hot Stocks20:14 EDT UiPath director sells $1.64M in common stock - In a regulatory filing, UiPath disclosed that its director Rich Wong sold 100K shares of common stock on September 22nd in a total transaction size of $1.64M.
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MKFG | Hot Stocks20:12 EDT Cathie Wood's ARK Investment bought 58.3K shares of Markforged today
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BYDIF JBL | Hot Stocks20:11 EDT Jabil to divest Mobility business to BYD Electronic for $2.2B - Jabil (JBL) "announced the signing of a definitive agreement to divest its Mobility business to BYD Electronic Company Limited (BYDIF) in a cash transaction valued at $2.2 billion. The definitive agreement follows a preliminary agreement announced by the two companies on August 27, 2023. Under the agreement, Jabil's Mobility business, which manufactures components for consumer electronics, will transfer to BYDE. The business is mainly located in Chengdu and Wuxi, China."
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MDRR | Hot Stocks19:45 EDT Medalist Diversified REIT CEO buys $58.2K in common stock - In a regulatory filing, Medalist Diversified REIT disclosed that its CEO Frank Kavanaugh bought 2.5K shares of common stock on September 22nd in a total transaction size of $58.2K.
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CARR | Hot Stocks18:46 EDT Carrier Global CEO: Viessmann expected to have strong growth in Europe - In an interview on CNBC's Mad Money, David Gitlin said Carrier has the capital to accelerate its share buyback and pay down debt. He's seeing a transition from fossil fuel heating to renewables and expects the trend to continue. The transition to EVs will happen to homes and buildings next, he added. He expects the company's K-12 business to be up 20% this year.
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NEE CPK | Hot Stocks18:04 EDT NextEra to sell Florida City Gas to Chesapeake for $923M in cash - NextEra Energy (NEE) announced its Florida Power & Light Company subsidiary has entered into a definitive agreement to sell Florida City Gas to Chesapeake Utilities Corporation (CPK) for $923M in cash. "We are pleased that FPL has reached this agreement to sell FCG to Chesapeake Utilities," said John Ketchum, chairman, president and chief executive officer, NextEra Energy. "This transaction allows us to continue our strategy of redeploying capital into our core businesses. I want to thank the FCG team for their hard work and accomplishments and am confident they will continue to be successful in the years to come." The transaction value of $923M, including $145M of intercompany debt, is expected to be accretive to NextEra Energy earnings immediately upon closing. The impact of the gain on sale at the time of closing will be excluded from adjusted earnings. Expected to be completed over the next several months, the sale is conditioned upon satisfaction of the Hart-Scott-Rodino review and customary closing conditions.
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CALT | Hot Stocks18:00 EDT Calliditas gets FDA orphan designation for treatment of Alport syndrome - According to a post on the FDA's website, Calliditas Therapeutics received orphan designation for its treatment of Alport syndrome. Reference Link
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BMRN | Hot Stocks17:58 EDT BioMarin receives FDA orphan designation for HCM treatment - According to a post on the FDA's website, BioMarin receives orphan designation for its treatment of patients with hypertrophic cardiomyopathy with a mutation in the MYBPC3 gene. Reference Link
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HYZN | Hot Stocks17:54 EDT Hyzon resolves SEC investigation for $25M without addressing allegations - Hyzon Motors announced a final resolution of the investigation by the SEC, subject to court approval. The investigation was previously reported by the company on January 12, 2022. "Hyzon is pleased to put this chapter behind us, and continue our disciplined execution of operational milestones including commercial vehicle deployments and fuel cell technology developments," said Hyzon Motors' CEO Parker Meeks. Without admitting or denying the allegations in the SEC's complaint, Hyzon has agreed to pay a civil monetary penalty of $25M in three installments: $8.5M within 30 days of entry of final judgment; $8.5M by December 31, 2024; and $8M within 730 days of entry of final judgment. In the second quarter of 2023, Hyzon accrued a $22M loss contingency, based upon management's assessment of the SEC investigation. Also named in the SEC's complaint were Craig Knight, the company's former CEO and a former director, and Max C.B. Holthausen, a former managing director of the company's European subsidiary, Hyzon Motors Europe B.V. Knight and Holthausen also separately consented to the entry of final judgments, subject to court approval, resolving the SEC's allegations.
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ACAQ | Hot Stocks17:38 EDT Athena Consumer Acquisition to delist upon combination with Next.e.GO Mobile - Athena Consumer Acquisition announced that, upon the consummation of its previously announced proposed business combination with Next.e.GO Mobile, it intends to voluntarily delist its Class A common stock, units and public warrants from the NYSE American, subject to the satisfaction or waiver, as applicable, of all closing conditions in connection with the Business Combination. The Company's Class A common stock, units and public warrants will continue to trade on the NYSE American under the symbols "ACAQ," "ACAQ.U" and "ACAQ WS," respectively, until the consummation of the Business Combination.
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FICO | Hot Stocks17:37 EDT FICO exec sells $2.52M in common stock - In a regulatory filing, FICO disclosed that its exec James Wehmann sold 2.8K shares of common stock on September 22nd in a total transaction size of $2.52M.
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PLTR | Hot Stocks17:33 EDT Palantir awarded $250M Army contract - Palantir was awarded a $250M firm-fixed-price contract to conduct research and development services in the area of artificial intelligence and machine learning. Work locations and funding will be determined with each order, with an estimated completion date of September 25, 2026. Army Contracting Command is the contracting activity.
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COST | Hot Stocks17:30 EDT Costco says inventory shrinkage not a big issue - Says selling one ounce gold bars on website, but are going fast and limited to two per customer. Says membership price increase is a question of when and not if. Says feels good about member loyalty and member growth. Says wants to be first to lower prices to drive sales. Comments taken from Q4 earnings conference call.
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HAYW CIVI | Hot Stocks17:19 EDT Hayward to replace Civitas Resources in S&P 600 at open on 9/29
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CIVI SYNH | Hot Stocks17:18 EDT Civitas Resources to replace Syneos Health in S&P 400 at open on 9/29 - Elliot Investment Management is acquiring Syneos Health (SYNH) in a deal expected to be completed soon pending final conditions.
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WEAV AFRM | Hot Stocks17:15 EDT Weave partners with Affirm to expand payment options for patients - Weave (WEAV), "an all-in-one experience platform for small and medium-sized healthcare businesses," announced a new partnership with Affirm (AFRM), the payment network that empowers consumers and helps merchants drive growth. Now available to thousands of Weave's customers, this collaboration provides flexible payment options for eligible patients, making it easier for them to access and afford the care they need. By partnering with Affirm, Weave customers can offer their patients pay-over-time financing with as low as 0% APR. Affirm is directly integrated with Weave payments, so patients can apply to pay with Affirm in a matter of seconds, and spread out their payments over time, easing the burden of upfront costs and providing an additional payment option for dental, optometry, veterinary, or medical practices. This partnership will not only benefit patients but also allow healthcare practices to receive payments quicker than before.
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OVV | Hot Stocks17:10 EDT Ovintiv renews annual buyback program - Ovintiv "announced it has received regulatory approvals for the renewal of its share buy-back program. This action is consistent with the Company's capital allocation framework, which returns at least 50 percent of post base dividend Non-GAAP Free Cash Flow to shareholders."
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DELL QCOM | Hot Stocks17:09 EDT Dell Technologies names Steve Mollenkopf to board of directors - Dell Technologies (DELL) has appointed Steve Mollenkopf as its newest independent member of the Dell Technologies board of directors, effective Sept. 27, 2023. Additionally, Simon Patterson, managing director of Silver Lake, has resigned as a member of the board of directors, effective Sept. 26, 2023. With the appointment of Mollenkopf, the Dell Technologies board of directors now seats eight directors, six of which are independent members. Steve Mollenkopf served as the CEO of Qualcomm (QCOM) from 2014 to 2021.
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DELL QCOM | Hot Stocks17:07 EDT Dell Technologies names Steve Mollenkopf to board of directors - Dell Technologies (DELL) has appointed Steve Mollenkopf as its newest independent member of the Dell Technologies board of directors, effective Sept. 27, 2023. Additionally, Simon Patterson, managing director of Silver Lake, has resigned as a member of the board of directors, effective Sept. 26, 2023. With the appointment of Mollenkopf, the Dell Technologies board of directors now seats eight directors, six of which are independent members. Steve Mollenkopf served as the CE of Qualcomm (QCOM) from 2014 to 2021.
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GSUN | Hot Stocks17:03 EDT Golden Sun Education Group discloses Nasdaq listing deficiency notice - Golden Sun Education "announced that the company received written notification from the Nasdaq Stock Market LLC on September 22, 2023, notifying the company that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Listing Rules for continued listing on Nasdaq."
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GNSS | Hot Stocks17:02 EDT Genasys to acquire Evertel in $5.8M cash and stock deal - Genasys announced that it has entered into a definitive agreement to acquire Evertel Technologies, a cross-agency collaboration platform for public safety. Genasys will be acquiring Evertel in a cash and stock deal for a total consideration of $5.8M. "Combining the two solutions will revolutionize inter and intra agency collaboration, adding a compliant, real-time layer of communication and intelligence sharing between first responders and emergency managers" said Richard Danforth, Chief Executive Officer of Genasys Inc. "Planning, actioning and optimizing every stage of emergency response before and during an incident needs to be interoperable, trustworthy and transparent." Under the definitive agreement, Genasys has agreed to acquire Evertel, from Word Systems Operations for approximately $5.8M, comprised of approximately 75% stock and 25% cash, subject to customary adjustments. Genasys expects the cash consideration to be financed through cash on hand. The transaction is expected to close the first week of October.
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MCLD | Hot Stocks17:01 EDT mCloud Technologies to delist from Nasdaq - mCloud Technologies announced it would not meet the listing requirements of the Nasdaq Stock Market LLC. As such, Nasdaq has determined it will delist the Company's securities.
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SLNH... | Hot Stocks17:01 EDT Soluna's Project Dorothy 1 reaches full capacity - Soluna Holdings announced it has brought Project Dorothy 1 fully online, with a focus on sustainability and enabling more renewable energy on the grid, completing construction on Project Dorothy 1B, and deploying 50 MW of Bitcoin mining machines for its hosting and proprietary businesses. This now brings Soluna to 2.6 EH/s under management. John Belizaire, CEO of Soluna Holdings, commented, "We've had a busy summer ramping Project Dorothy through record high temperatures. As we approach the peak wind months and cooler temperatures in Texas, we have achieved a key milestone to complete Project Dorothy 1 and bring it to its 50 MW capacity. We have also made great progress accelerating development at Project Dorothy 2, Project Kati, and working on operational improvements, including significant reductions in SG&A. We also began delivering on our promise to mitigate curtailment for renewable energy power projects."
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MORF | Hot Stocks16:57 EDT Morphic CEO Dr. Praveen Tipirneni takes leave after 'emergent medical event' - Morphic Holdings announced that Chief Executive Officer Dr. Praveen Tipirneni suffered an emergent medical event and is taking a medical leave of absence. Dr. Tipirneni is expected to return to his role as Chief Executive Officer after he recovers. In the interim, Morphic's executive team, led by Dr. Bruce Rogers, President and Dr. Marc Schegerin, COO and CFO, will continue with its leadership in day-to-day operational activities on a normal basis. "Praveen's health and continued recovery is the only focus for him and his family. We are sending them our thoughts and support and we look forward to him returning in good health," said Gustav Christensen, Morphic's Chairman of the Board of Directors. "In the meantime, our highly seasoned and experienced executives will work collaboratively, as always, to maintain business operations and ensure that the Company's strategic objectives remain on track during Praveen's leave." Morphic expects no interruptions or changes to its business operations and will provide an update on Dr. Tipirneni's health as soon as is practicable. The Company remains confident in its differentiated proprietary pipeline and MInT platform technology to treat the high unmet need of serious chronic diseases, including the development prospects for MORF-057 in IBD.
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PCRX | Hot Stocks16:31 EDT Pacira CEO, chairman David Stack to retire - Pacira announced that David Stack will retire from his role as chairman and CEO. To ensure a transition, Stack has committed to continuing in his current role until a new CEO is appointed by the board of directors, who are conducting the search. He will then continue in a consulting role with the company through August of 2025. The company's board has retained Klein Hersh International, an executive search firm to assist in a search for the company's next chief executive officer.
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MLKN | Hot Stocks16:27 EDT MillerKnoll jumps 16% to $22.25 after Q1 results beat, FY24 guidance raised
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AES | Hot Stocks16:18 EDT AES Corp. announces minority sell-downs of LNG businesses in Panama, D.R. - The AES Corporation announced that it has agreed to minority sell-downs of its businesses in the Dominican Republic and Panama, as an expansion of its existing strategic partnership with Grupo Linda and a new partnership with Grupo Popular's subsidiary, AFI Popular, through one of its closed end funds. The sell-down agreements will provide collective proceeds of $190M to AES, putting the company on track to achieve its asset sale proceeds target for the year. As a result, AES has secured all external funding included in its 2023 capital plan, which is comprised of the proceeds from these sell-down agreements, plus those from other transactions announced earlier this year, such as the Warrior Run Power Purchase Agreement termination, and the issuance of $900M of senior notes in May, priced at 5.450%. The agreements announced include the sale of 10% of AES' business in the Dominican Republic to Grupo Linda and Grupo Popular's subsidiary, AFI Popular. AES' businesses in the Dominican Republic include an LNG regasification terminal, with a 160,000 m3 LNG capacity storage tank, the AES Andres 319 MW combined cycle gas turbine plant, DPP 328 MW combined cycle gas turbine, as well as an additional 150 MW of solar and wind power plants. The announcement includes the sale of 20% of AES Colon in Panama, also to Grupo Linda. AES Colon includes a 381 MW combined cycle gas turbine with an adjacent regasification facility that has a 180,000 m3 LNG capacity storage tank.
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PPG | Hot Stocks16:17 EDT PPG names Tim Knavish as new CEO - PPG "announced that its Board of Directors has unanimously elected PPG president and chief executive officer, Tim Knavish as chair of the company's Board of Directors and CEO, effective Oct. 1, 2023. Knavish succeeds Michael McGarry, who served as chairman and CEO from 2016 to 2022 and is retiring as executive chairman, also effective Oct. 1, 2023. Knavish joined PPG in 1987 at PPG's global headquarters in Pittsburgh and he has held roles of increasing responsibility during his 36 years with the Company."
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DHC | Hot Stocks16:17 EDT Diversified Healthcare Trust names Matthew Brown CFO - Diversified Healthcare Trust announced changes to its Board of Trustees and executive leadership team, and other actions to address its near term capital needs, including DHC's pending debt maturities. Phyllis Hollis has been appointed as an Independent Trustee of the DHC Board, effective September 26, 2023. Ms. Hollis previously worked as an executive at an investment bank and has extensive experience in finance and executing capital markets transactions. Ms. Hollis will serve on DHC's Audit Committee as well as its Compensation Committee, which she will chair. Adam Portnoy, Chair of DHC's Board, made the following statement: "On behalf of the DHC Board, I am excited to welcome Phyllis as our newest Board member. Phyllis is a recognized industry veteran with substantial executive and finance experience. We look forward to drawing on her insights and perspectives as we consider alternatives to address DHC's near term financing needs and generally oversee DHC's path forward." In addition, DHC has appointed Matthew Brown as Chief Financial Officer and Treasurer, effective October 1, 2023.
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PTON | Hot Stocks16:16 EDT Peloton appoints Nick Caldwell as Chief Product Officer - Peloton announced the appointment of Nick Caldwell as Chief Product Officer, or CPO, effective November 1. A Silicon Valley veteran with more than 20 years of global leadership experience, Caldwell joins the team with a proven track record of building and scaling products and services that excite customers, drive business growth, and deliver impact. Caldwell succeeds Peloton Co-Founder, Tom Cortese, and will report to CEO Barry McCarthy, leading global product development. As Co-Founder and Chief Product Officer, Cortese helped push Peloton into new areas of fitness and innovation. As of November 1 Cortese will move into an advisory role with the company, continuing to support its vision and growth.
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SEVN RMR | Hot Stocks16:15 EDT Seven Hills Realty Trust names Fernando Diaz CFO - Seven Hills Realty Trust (SEVN) announced the appointment of Fernando Diaz, CFA, as Chief Financial Officer and Treasurer, effective October 1, 2023. Diaz joined The RMR Group (RMR) in 2007 and currently serves as a Vice President, responsible for credit risk and business analytics. Mr. Diaz has over 15 years of experience as a securities analyst and portfolio manager. Prior to the Trust's deregistration as an investment company, which was effective on January 5, 2021, he served as president and senior portfolio manager of the Trust from 2015 to January 2021 and as a vice president and portfolio manager of the Trust from 2007 to 2015. Prior to joining RMR in 2007, Mr. Diaz was a senior real estate investment trust ("REIT") analyst and an assistant portfolio manager with GID Securities, LLC and a senior REIT analyst and assistant portfolio manager with State Street Global Advisors/The Tuckerman Group. Mr. Diaz earned a bachelor's degree in Mechanical Engineering from Northeastern University and a Master of Business Administration in Finance from Bentley University. Mr. Diaz holds the Chartered Financial Analyst designation and is a member of the CFA Society Boston.
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ILPT | Hot Stocks16:15 EDT Industrial Logistics Property Trust names Tiffany Sy as new CFO - Industrial Logistics Properties "announced that Tiffany Sy has been appointed as Chief Financial Officer and Treasurer, effective October 1, 2023. Ms. Sy has served in finance and accounting leadership roles at The RMR Group (Nasdaq: RMR) since 2020."
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GNFT | Hot Stocks16:14 EDT Genfit publishes NIS4 NASH diagnostic technology data - Genfit announced the publication of data demonstrating the effectiveness of its non-alcoholic steatohepatitis, or NASH, diagnostic technology NIS4 by the FNIH's NIMBLE project in the scientific journal, Nature Medicine. NIMBLE, part of the FNIH Biomarkers Consortium, is a public-private partnership that brings together U.S. government agencies, academic researchers and industry partners to study the diagnostic performance of non-invasive biomarkers to assess liver disease. The recent study evaluated five blood-based panels, which included NIS4, NIS2+'s predecessor. The study aims to confirm the diagnostic performances of existing biomarker panels and determine their advantage over commonly used laboratory tests. Such studies conducted provide necessary data for the regulatory approval of biomarkers for the diagnosis of at-risk NASH and is a crucial step in moving the field closer to having qualified Non-Invasive Tests, such as NIS4 or now NIS2+, that can be used for widespread clinical use. The findings, published in the scientific journal Nature Medicine, concluded that NIS4 achieved an AUROC6 of 0.815 for its intended use of diagnosing at-risk NASH, demonstrating significant superiority over common clinical-laboratory tools. It also confirmed that NIS4 was the only panel efficient for the diagnosis of the composite phenotype of at-risk NASH. Regarding the detection of NASH and significant fibrosis independently, NIS4's performance was superior to the other biomarker panels tested, achieving AUROC values of 0.832 and 0.874, respectively. These findings represent an important milestone in NIS4 technology's path to regulatory approval by the FDA. NIS2+, the newly published and optimized version of NIS4, is currently in the process of being independently evaluated through the NIMBLE consortium.
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CRDF | Hot Stocks16:13 EDT Cardiff Oncology announces results from trials in mPDAC and SCLC - Cardiff Oncology announced positive clinical data with onvansertib monotherapy and combination therapy in our ongoing trials in metastatic pancreatic ductal adenocarcinoma, or mPDAC, and small cell lung cancer, or SCLC, as well as plans for a mPDAC first-line investigator-initiated trial, or IIT, of the combination of onvansertib plus standard-of-care, or SoC. Data from the ongoing Phase 2 open-label trial of onvansertib combined with nanoliposomal irinotecan, leucovorin, and 5-FU in patients with second-line mPDAC demonstrated an objective response rate, or ORR, of 19% and median progression-free survival (mPFS) of 5.0 months as of the data cutoff of September 13. Historical control trials in similar patient populations have shown an ORR of 7.7% and mPFS of 3.1 months with SoC. The investigator-initiated biomarker discovery trial is exploring the impact of onvansertib 10-day monotherapy on tumors in mPDAC patients, and is currently enrolling at the Oregon Health & Science University Knight Cancer Institute. Two patients have been enrolled to date. One patient demonstrated an 86% decrease in Ki67, a well-established biomarker of tumor proliferation, and a 28% decrease in CA 19-9, a clinically-used biomarker to monitor treatment response. The next trial in mPDAC will be a new Phase 2 investigator-initiated trial at OHSU Knight Cancer Institute in mPDAC in the first-line setting. There are two cohorts in this trial. In cohort 1, patients will receive the combination of onvansertib with SoC. In cohort 2, patients will receive 10 days of onvansertib monotherapy followed by onvansertib + SoC to identify biomarkers that predict response to onvansertib.
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ADVM | Hot Stocks16:12 EDT Adverum announces aflibercept protein expression data from Luna trial - Adverum Biotechnologies announced initial aflibercept protein expression data from its ongoing Phase 2 LUNA trial evaluating ixoberogene soroparvovec, Ixo-vec, for the treatment of wet age-related macular degeneration, wet AMD . New data announced today include aflibercept protein levels for both the 2E11 and 6E10 vg/eye doses, suggesting that both doses are within the therapeutically active range. Notably, these protein expression levels are consistent with levels observed in the OPTIC trial, in which aflibercept levels and corresponding clinical activity have been sustained in patients through multiple years of follow-up after a single Ixo-vec injection. "This first data cut from the LUNA trial is highly encouraging, showing similar aflibercept expression levels at the 2E11 and 6E10 doses," stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. ..Fischer continued, "We are pleased with the promising emerging LUNA clinical activity and safety data. At AAO this year, we look forward to presenting updated long-term follow-up data from the OPTIC trial, showing aflibercept protein levels out to four years, and clinical efficacy and safety data out to three years after a single Ixo-vec injection. We also look forward to providing initial LUNA clinical activity and safety data once a meaningful subset of patients have completed the corticosteroid prophylactic taper regimens." ...These results from the LUNA study could be clinically meaningful as the aflibercept levels measured in this trial are comparable to the sustained aflibercept levels seen in patients treated in the OPTIC trial."Initial Phase 2 LUNA efficacy and safety data anticipated in Q4 2023 .
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PIXY | Hot Stocks16:10 EDT ShiftPixy says reverse stock split to become effective September 30 - ShiftPixy announced that at 11:59:59 p.m. on September 30, 2023, in Wyoming, pursuant to the vote of its shareholders on August 21, 2023, to effect a one-for-twenty-four (1:24) reverse split of the Company's issued and outstanding shares of Common Stock, as further detailed in the Company's definitive Schedule 14C Information Statement filed on September 1, 2023, Articles of Amendment of the Company's Amended and Restated Articles of Incorporation will become effective as filed with the Secretary of State of Wyoming. The new reversed shares will begin trading on Nasdaq on October 2, 2023.
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TRUE | Hot Stocks16:08 EDT TrueCar names Oliver Foley as CFO, replacing Teresa Luong - TrueCar announced new leadership appointments and role changes. Oliver Foley is joining TrueCar as CFO, replacing Teresa Luong. Jay Ku will be shifting roles from Chief Commerce Officer which he took on in February 2023, to Chief Revenue Officer. Foley will start at TrueCar on October 30 and will be responsible for the company's financial strategy, accounting operations, corporate finance, tax compliance and investor relations. He will report to Jantoon Reigersman, President and CEO. Foley has spent over 10 years in senior corporate finance and strategy roles across several high-growth consumer brands. He will be joining TrueCar from Flexcar, LLC, a leading vehicle-subscription business in the U.S. where he led the Finance and Accounting, Risk and Analytics teams responsible for shaping the company's long-term business strategy and growth objectives. As Chief Revenue Officer, Ku will oversee Dealer Sales and Retention, Wholesale, Affinity Network, and OEM Solutions, in addition to existing oversight of marketing and communications. He will continue to report to Reigersman.
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AOUT | Hot Stocks16:06 EDT American Outdoor Brands secures patent settlement with The Allen Company - American Outdoor Brands announced that it has secured a settlement, including a permanent injunction entered by the United States District Court for the District of Colorado on September 25, 2023, with The Allen Company, related to Allen's infringement of AOB's patent rights. AOB's trademark and patent infringement action against Allen was initiated in February 2023 and was related to Allen's alleged repeated infringement of AOB's patent rights incorporated in the LEAD SLED shooting rests; Orange Peel shooting targets; and Ultimate Target Stand through Allen's sales of the Shottrax and Shot-Rock shooting rests; EZ Aim targets; and the Precision Target Stand, respectively. On September 25, 2023, the United States District Court for the District of Colorado entered a permanent injunction against Allen enjoining Allen from making, using, importing, selling, or offering for sale Shottrax and Shot-Rock shooting rests SKU Nos. 21922 and 21925; EZ Aim targets SKU Nos. 15253, 15229, 15224, 15222, 15228, 15225, 15252, 15226, and 15223; and the Precision Target Stand SKU No. 15296.
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GRCL | Hot Stocks16:06 EDT Gracell:1st patient dosed in a Phase 1b/2 trial to evaluate GC012F in RRMM - Gracell Biotechnologies announced that the first patient has been dosed in a Phase 1b/2 clinical trial evaluating its lead candidate, GC012F, in patients with relapsed or refractory multiple myeloma or RRMM, in the United States. GC012F is the Company's autologous therapeutic candidate dual-targeting B cell maturation antigen BCMA and CD19, developed on the proprietary FasTCAR next-day manufacturing platform. The Phase 1b portion of the open-label multi-center trial has been initiated and will be conducted at several top medical centers in the United States. The study expects to enroll approximately 12 patients at two dose levels and is designed to evaluate the safety and tolerability of GC012F in RRMM patients, determine the recommended dose of GC012F for Phase 2 and characterize the pharmacokinetics of GC012F in RRMM patients. The Phase 2 portion is intended to evaluate the efficacy of GC012F in RRMM patients and further characterize the safety of GC012F. "Gracell has amassed a body of compelling evidence supporting the dual-targeting approach of GC012F for treatment of RRMM. Based on its fast, deep and durable responses as well as the differentiated safety profile observed in prior clinical studies, we firmly believe that GC012F has the potential to emerge as a leading treatment option and benefit patients across disease stages," said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell. "Dosing the first patient in the Phase 1b portion of the U.S. trial is another important step toward validating this treatment for RRMM patients."
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VLD | Hot Stocks16:06 EDT Velo3D CFO McCombe resigns - Velo3D announced William McCombe has resigned as the company's Chief Financial Officer, effective September 29, 2023, to pursue other career opportunities. Bernard Chung, Velo3D's Vice President of Finance has been appointed Acting CFO, effective September 29, 2023. McCombe has agreed to stay on in a transition capacity through November 7, 2023 and will participate in the company's third quarter earnings conference call on November 7, 2023. "I want to thank Bill for his dedication and leadership over the last three years as he guided the company through the listing process and helped successfully grow Velo3D into one of the leading technology suppliers in the additive manufacturing industry," said Benny Buller, CEO of Velo3D. "I wish Bill the best of luck in his future endeavors. I am also pleased to welcome Bernie as our Acting Chief Financial Officer and look forward to continuing to build on our 3-year partnership. Given his more than 20 years of finance experience, we expect a seamless transition as he takes on his new responsibilities."
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WSBF | Hot Stocks16:05 EDT Waterstone Financial to reduce dividend payment - Waterstone Financial announced a strategic decision to reduce its dividend payout as part of a broader initiative to optimize capital allocation. The company said, "This move is aimed at enhancing shareholder value through stock buybacks, which we believe will generate long-term benefits for both Waterstone and its shareholders. The board of directors declared a quarterly dividend of 15c per common share." The dividend will be payable November 1 to shareholders of record at the close of business on October 9.
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GLTO | Hot Stocks16:03 EDT Galecto to explore strategic alternatives, reduce workforce by 70% - Galecto announced that it has completed a review of its business, including the status of its programs, resources, and capabilities. Galecto has made the determination to conduct a comprehensive exploration of strategic alternatives. As part of this evaluation process, Galecto will explore potential strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination, divestiture of its assets, technologies or capabilities, or other transaction. There can be no assurance that its exploration will result in Galecto pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms, if at all. In connection with the evaluation of strategic alternatives, Galecto plans to implement a restructuring plan that includes reducing its workforce by approximately 29 people, or approximately 70% of its existing headcount. Galecto has not set a timetable for completion of the evaluation process and does not intend to disclose further developments or guidance on the status of its programs unless and until it is determined that further disclosure is appropriate or necessary. As of June 30, Galecto's cash, cash equivalents and investments balance was $52.1M.
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MLI | Hot Stocks16:01 EDT Mueller Industries announces 2-for-1 stock split - Mueller Industries announced that its Board of Directors has declared a two-for-one stock split to be effected in the form of a 100% stock dividend. Stockholders of record on October 6, 2023 will receive one additional share of common stock for each share of the company's common stock held on that date. The distribution date for the stock split, or the date on which new shares will be distributed from the company's transfer agent, Equiniti Trust Company, LLC, will be October 20, 2023. Following the stock split, the company's outstanding common shares will increase to approximately 113.5M shares.
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NYX | Hot Stocks15:58 EDT NYIAX enters into settlement pact, release with Boustead Securities - According to a regulatory filing, on September 20, 2023, NYIAX entered into a Settlement Agreement and Release with Boustead Securities, LLC to settle any and all potential claims and counterclaims that may arise from the consummation of certain financing transactions pursuant to that certain engagement letter, dated March 23, 2021, by and between the company and Boustead. In March 2023, the company delivered notice of termination of the Engagement Letter to Boustead and subsequently engaged another underwriter to complete its initial public offering. Boustead has claimed that under the Engagement Letter, the company owes or will owe Boustead approximately $1M for commissions on funds privately raised by the company during its engagement with Boustead and approximately $1,230,000 if the company completes an IPO with another underwriter. The company disputes the amounts owed that have been claimed by Boustead. Pursuant to the terms of the Agreement, and in order to settle the dispute with Boustead amicably and efficiently, the company and Boustead have agreed to a contingent mutual release and waiver of claims in exchange for a cash payment of $515,000 by the Company to Boustead as a deduction from the offering proceeds upon consummation of the company's IPO. The Agreement also provides Boustead for certain indemnification under Section 4 of the Engagement Letter. Unless otherwise amended, the Agreement shall be deemed null and void in the event the company's IPO is not consummated by December 31, 2023. If the settlement is finalized with the consummation of the company's initial public offering, the company does not anticipate any additional charges related to this threatened litigation.
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RH | Hot Stocks15:17 EDT RH CEO 'disappointed' One Ocean Drive proposal not recommended - RH provided an update regarding its intention to reimagine and restore One Ocean Drive, Miami Beach and the ongoing RFP process, with RH Chairman and CEO Gary Friedman quoted as having said: "While disappointed that our proposal was not recommended for selection, we continue to believe One Ocean Drive is one of the most important addresses in the world. Our goal from the beginning of this process was to deliver something that the City and its residents could be proud of, and that would cement Miami Beach's place as one of the most important global cities for architecture, design, creativity, culture, health, wellness, food and wine... While this process has certainly seemed rushed, our sense is that due to the ongoing litigation, upcoming elections and the fact that the current operator has 2.5 years left on their lease, the final outcome will remain uncertain for some time. RH remains willing and ready, if invited, to engage with the residents and City of Miami Beach to refine and improve our proposal, resulting in a reimagination of One Ocean Drive, not only as a 'High End Beach Establishment' as the RFP requested, but as a one-of-a-kind iconic beach destination that inspires the local community and enlightens a global audience."
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NFLX... | Hot Stocks15:05 EDT FCC Chair proposes to restore 'net neutrality' rules - Chairwoman Rosenworcel shared with her colleagues a proposal that would begin the process of re-establishing the FCC's oversight over broadband and restoring uniform, nationwide net neutrality rules, the FCC announced. Companies that have made public statements regarding "net neutrality" or could be impacted by the rules include Netflix (NFLX), AT&T (T), Verizon (VZ), Comcast (CMCSA), Charter (CHTR), Amazon (AMZN), Apple (AAPL), Google (GOOGL), Meta (META), Disney (DIS), Warner Bros. Discovery (WBD), Paramount (PARA) and Sony (SONY). Reference Link
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TGT | Hot Stocks15:04 EDT Target to close nine stores across four states over thefts - Target said in a statement, "At Target, we take the decision to close stores very seriously, and only do so after taking meaningful steps to invest in the guest experience and improve business performance. With that said, we have made the difficult decision to close nine Target stores across four states, effective Oct. 21. In this case, we cannot continue operating these stores because theft and organized retail crime are threatening the safety of our team and guests, and contributing to unsustainable business performance. We know that our stores serve an important role in their communities, but we can only be successful if the working and shopping environment is safe for all. Before making this decision, we invested heavily in strategies to prevent and stop theft and organized retail crime in our stores, such as adding more security team members, using third-party guard services, and implementing theft-deterrent tools across our business. Despite our efforts, unfortunately, we continue to face fundamental challenges to operating these stores safely and successfully." The stores being closed are in the New York City, Seattle, San Francisco, Oakland, and Portland markets. Reference Link
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AN PDGNF | Hot Stocks14:40 EDT AutoNation confirms submitted non-binding preliminary proposal to buy Pendragon - In a regulatory filing, AutoNation (AN) stated: "On September 26, 2023, Pendragon PLC (PDNGF) issued an announcement stating that AutoNation submitted a non-binding, preliminary proposal to acquire the entire issued and to be issued share capital of Pendragon. Following its receipt of the Proposal, the board of directors of Pendragon publicly announced that they intend to consider the Proposal and will consult with their shareholders and provide an update in due course... There can be no certainty as to whether the Company will make a binding offer for Pendragon. The Company makes no representation as to the accuracy or completeness of the Pendragon Announcement, which was issued without the consent of the Company. The Company confirms that it has submitted to Pendragon a non-binding preliminary proposal to acquire Pendragon's entire issued and to be issued share capital for 32 pence per share and that the acquisition would not require approval by the Company's stockholders or include the issuance of any equity securities of the Company. The Company will make a further announcement if and when appropriate."
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NTNX | Hot Stocks14:34 EDT Nutanix sees FY27 ACV billings of $2.1B-$2.2B - Guidance from investor day slides.
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BG | Hot Stocks14:32 EDT Canada launching review of proposed acquisition of Viterra by Bunge - Canada's Minister of Transport, the Honourable Pablo Rodriguez, issued the following statement: "A strong transportation supply chain means more affordable, more available products for Canadians. In order to ensure that we have fair competition at Canada's ports, the Government of Canada is launching a review of the proposed acquisition of grain handler Viterra Limited by Bunge Limited, a global agricultural company. Both companies hold ownership interests in port terminals throughout our country. Healthy competition in the transportation sector is necessary to ensure fair pricing and access for users, especially for Canadian farmers. Given this transaction is of significant national interest in Canada's transportation sector and the broader supply chain, it will be reviewed under the mergers and acquisitions provisions of the Canada Transportation Act. Goods must continue to move smoothly, and our supply chain must continue to grow stronger. This is why the Government will launch a public interest assessment that will include consultations with Canada's ports and marine industry, stakeholders, other government departments, other orders of government, and Canadians. Transport Canada has up to 250 days, or until June 2, 2024, to complete the public interest assessment." Reference Link
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LYV | Hot Stocks14:02 EDT Live Nation will drop merch fees, offer cash stipends to developing artists - Live Nation has launched "On the Road Again", a new program created with country singer Willie Nelson to support developing artists and the integral teams that support them. "Touring is important to artists so whatever we can do to help other artists, I think we should do it. This program will impact thousands of artists this year and help make touring a little bit easier," said Willie Nelson, who provided his famous hit song "On the Road Again" as the anthem for the program. Through the end of the year, the On The Road Again program is expected to deliver tens of millions of dollars in extra earnings to club artists and crew by: supporting developing artists; thanking Behind-The-Scenes Heroes; and lending a hand to crew across the industry. All of Live Nation's clubs are investing in developing artists by providing $1,500 in gas and travel cash per show to all headliners and support acts, on top of nightly performance compensation. Additionally, these clubs will charge no merchandise selling fees, so artists keep 100% of merch profits. Touring is a crucial part of an artist's livelihood, and we understand travel costs take one of the biggest bites out of artists' nightly profits. In addition, On The Road Again is providing financial bonuses to local promoters that help execute at shows, tour reps that live life on a bus, as well as venue crew members that have worked over 500 hours in 2023. On the Road Again is also donating $5M to Crew Nation to support crew across the industry facing unforeseen hardship. "Delivering for live artists is always our core mission," said Michael Rapino, President and CEO of Live Nation Entertainment. "The live music industry is continuing to grow and as it does, we want to do everything we can to support artists at all levels on their touring journey especially the developing artists in clubs. Like Willie says, this is all about making it a little easier for thousands of artists to continue doing what they love: going out and playing for their fans." Reference Link
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WFC | Hot Stocks13:37 EDT Wells Fargo, Centerbridge enter into strategic pact focused on direct lending - Centerbridge Partners and Wells Fargo & Company announced they are entering into a strategic relationship focused on direct lending to non-sponsor North American middle market companies. To meet the alternative credit needs of this segment, Centerbridge intends to launch Overland Advisors to manage a newly formed business development company that will be primarily focused on making senior secured loans. Overland represents a transformative new business model for direct lending to middle-market companies, diversifying the market of clients served by private credit and direct lending. The Centerbridge and Wells Fargo strategic relationship includes differentiated origination sourcing from Wells Fargo's extensive middle market customer base, and an equity investment from Wells Fargo. In addition to expanding financing access to the non-sponsor segment, Overland will pursue other transactions, including traditional sponsor-backed direct lending opportunities. Overland Advisors is targeting a minimum of $5B in investible capital, including $2.5B in equity commitments for this strategy. Anchor investors, including wholly owned subsidiaries of the Abu Dhabi Investment Authority and British Columbia Investment Management Corporation, have committed to provide nearly $2B in initial equity commitments. "Overland represents a new paradigm in direct lending, bringing a relationship approach to direct lending and offering a much-needed capital solution in the large but underpenetrated non-sponsor U.S. middle market," said Jeff Aronson, Co-Founder and Managing Principal of Centerbridge Partners. "We believe Overland draws on the unique and complementary capabilities of both Centerbridge's leading private credit underwriting capabilities and Wells Fargo's nationwide sourcing and origination network to offer an attractive new proposition for borrowers in the private lending and direct credit space at a particularly compelling time."
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NTNX | Hot Stocks13:12 EDT Nutanix sees driving to $3B ARR by FY27 - Sees "strong" ARR growth of about 20% CAGR from FY23-FY27. Sees free cash flow generation of about $800M by FY27. Sees driving towards being "Rule of 40+" company by FY27. Stock-based compensation is expected to be less than 10% of revenue by FY27. Guidance and comments from investor day presentation slides.
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AN PDGNF | Hot Stocks13:09 EDT Pendragon announces receipt of proposal from AutoNation - The board of directors of Pendragon (PDNGF) confirms that it has received an unsolicited proposal from AutoNation (AN) to acquire the entire issued and to be issued share capital of Pendragon for 32 pence per share, in cash, the company announced in a notice to the London Stock Exchange. "The AutoNation Proposal remains subject to a number of pre-conditions, including the completion of due diligence. The Board will consider the AutoNation Proposal and will consult with its shareholders and provide an update in due course. There can be no certainty that any firm offer will be made, nor to the terms of any such offer. Shareholders are advised to take no action at this time. As required by Rule 2.6(a) of the Code, AutoNation is required, by not later than 5.00 p.m. on 24 October 2023, either to announce a firm intention to make an offer for the Company in accordance with Rule 2.7 of the Code or to announce that it does not intend to make an offer, in which case the announcement will be treated as a statement to which Rule 2.8 of the Code applies. This deadline may be extended with the consent of the Takeover Panel in accordance with Rule 2.6(c) of the Code. The person responsible for arranging for the release of this announcement on behalf of Pendragon is Richard Maloney, Group General Counsel and Group Company Secretary. This announcement is made without the consent of AutoNation," the notice stated.
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NTNX | Hot Stocks12:57 EDT Nutanix targeting about 20% ARR CAGR and 'expanding profitability' - Comments from slides for Nutanix investor day.
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NTNX | Hot Stocks12:50 EDT Nutanix down 1% as investor day continues - Shares of Nutanix are down 51c, or 1%, to $34.87 as the company continues to conduct its investor day meeting. Reference Link
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AMZN | Hot Stocks12:21 EDT Amazon says FTC lawsuit 'wrong on the facts and the law' - Amazon.com said in a statement: "Today's suit makes clear the FTC's focus has radically departed from its mission of protecting consumers and competition. The practices the FTC is challenging have helped to spur competition and innovation across the retail industry, and have produced greater selection, lower prices, and faster delivery speeds for Amazon customers and greater opportunity for the many businesses that sell in Amazon's store. If the FTC gets its way, the result would be fewer products to choose from, higher prices, slower deliveries for consumers, and reduced options for small businesses-the opposite of what antitrust law is designed to do. The lawsuit filed by the FTC today is wrong on the facts and the law, and we look forward to making that case in court."
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FE | Hot Stocks12:20 EDT FirstEnergy board raises quarterly dividend 5% to 41c per share - The Board of Directors of FirstEnergy declared a quarterly dividend of 41c per share of outstanding common stock payable December 1, 2023, to shareholders of record at the close of business on November 7, 2023. This represents a 5% increase compared to quarterly payments of 39c per share paid by the company since March 2020.
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OCUP | Hot Stocks12:11 EDT Ocuphire Pharma up 12% to $4.37 after FDA posts approval of Ryzumvi
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OCUP | Hot Stocks12:10 EDT FDA website posts approval of Ocuphire Pharma's Ryzumvi - Reference Link
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SAP... | Hot Stocks12:06 EDT SAP announces 'Joule,' a natural-language, generative AI copilot - SAP SE (SAP) announced Joule, a natural-language, generative AI copilot that it says "will transform the way business runs." SAP stated: "Joule will be embedded throughout SAP's cloud enterprise portfolio, delivering proactive and contextualized insights from across the breadth and depth of SAP solutions and third-party sources. By quickly sorting through and contextualizing data from multiple systems to surface smarter insights, Joule helps people get work done faster and drive better business outcomes in a secure, compliant way. Joule delivers on SAP's proven track record of revolutionary technology that drives real results." SAP added: "Joule will be available with SAP SuccessFactors solutions and the SAP Start site later this year, and with SAP S/4HANA Cloud, public edition early next year... Joule builds on and enhances existing SAP Business AI offerings. More than 26,000 SAP cloud customers have access to SAP Business AI across multiple scenarios and partner solutions. SAP's comprehensive strategy to build an enterprise AI ecosystem of the future also includes direct investments, such as those announced in July with Aleph Alpha, Anthropic and Cohere, as well as third-party partnerships including those with Microsoft, Google Cloud and IBM announced in May. Sapphire Ventures LLC, a global software venture capital firm, is backed by SAP and is dedicating over US$1 billion to fund AI-powered enterprise technology startups."
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AMZN | Hot Stocks12:05 EDT FTC, 17 states sue Amazon for maintaining 'monopoly power' strategies - The Federal Trade Commission and 17 state attorneys general sued Amazon.com, alleging the company "is a monopolist that uses a set of interlocking anticompetitive and unfair strategies to illegally maintain its monopoly power." The FTC and its state partners say Amazon's actions "allow it to stop rivals and sellers from lowering prices, degrade quality for shoppers, overcharge sellers, stifle innovation, and prevent rivals from fairly competing against Amazon." The complaint alleges that Amazon "violates the law not because it is big, but because it engages in a course of exclusionary conduct that prevents current competitors from growing and new competitors from emerging." By stifling competition on price, product selection, quality, and by preventing its current or future rivals from attracting a critical mass of shoppers and sellers, Amazon ensures that no current or future rival can threaten its dominance, the FTC said in a statement. The FTC, along with its state partners, are seeking a permanent injunction in federal court "that would prohibit Amazon from engaging in its unlawful conduct and pry loose Amazon's monopolistic control to restore competition. Connecticut, Delaware, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New Hampshire, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, and Wisconsin joined the Commission's lawsuit. Reference Link
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GRND | Hot Stocks12:02 EDT Grindr appoints Zac Katz as general counsel, head of global affairs - Grindr announced the additions of three senior executives: Zac Katz as General Counsel and Head of Global Affairs, Tristan Pineiro as Vice President of Brand and Communications, and Solmaz Shariat Torbaghan as Director of Artificial Intelligence and Machine Learning. Katz, who will lead the legal and global affairs team, reporting to CEO George Arison, brings more than two decades of experience leading high-performing teams at the intersection of law, technology, and government. He was most recently Chief Legal & Corporate Affairs Officer at Age of Learning. Pineiro joins Grindr with over 20 years of experience in brand building and communications, previously leading global teams in both the U.K. and U.S. at mobile gaming company King. Shariat Torbaghan is a computer scientist. She has spent the last decade building cutting-edge AI models ranging from recommender systems to co-pilots across various industries, most recently as Director of Advanced AI at Varian building steerable generative AI in the medical field.
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AMZN | Hot Stocks12:01 EDT FTC files antitrust suit against Amazon for marketplace monopoly
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LABD | Hot Stocks12:00 EDT Daily S&P Biotech Bear 3x Shares falls -9.1% - Daily S&P Biotech Bear 3x Shares is down -9.1%, or -$1.97 to $19.71.
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ALUR | Hot Stocks12:00 EDT Allurion Technologies falls -9.1% - Allurion Technologies is down -9.1%, or -47c to $4.68.
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UNFI | Hot Stocks12:00 EDT United Natural Foods falls -23.4% - United Natural Foods is down -23.4%, or -$4.43 to $14.48.
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HRTG | Hot Stocks12:00 EDT Heritage Insurance rises 15.8% - Heritage Insurance is up 15.8%, or 83c to $6.09.
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FZT | Hot Stocks12:00 EDT Fast II rises 18.8% - Fast II is up 18.8%, or $2.00 to $12.64.
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FSR | Hot Stocks12:00 EDT Fisker rises 20.5% - Fisker is up 20.5%, or $1.09 to $6.40.
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ENLT AMAT | Hot Stocks11:05 EDT Enlight Renewable to supply renewable energy to Applied Materials Israel - Enlight Renewable Energy (ENLT) announce that Applied Materials Israel (AMAT) has entered into a 15-year corporate power purchase agreement for the supply of renewable energy to its Israeli operations. The electricity will be sourced from Enlight's solar and storage facilities currently under construction in Israel. The agreement comes with an option to increase consumption volumes based on Applied Material Israel's needs.
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WTW | Hot Stocks10:55 EDT Willis Towers Watson increases share repurchase program by $1B - WTW announced that its board of directors approved an increase to the existing share repurchase authority in the amount of $1B. The $1B increase is in addition to the approximately $545M remaining on the current open-ended repurchase authority. "The company is authorized to repurchase shares, by way of redemption or otherwise, and will consider whether to do so from time to time, based on many factors, including market and economic conditions, applicable legal requirements and other business considerations," WTW stated.
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MSTR | Hot Stocks10:55 EDT MicroStrategy buys 5,445 bitcoins for $147.3M in cash - In a Monday regulatory filing, MicroStrategy said, "On September 25, 2023, MicroStrategy announced that, during the period between August 1, 2023 and September 24, 2023, MicroStrategy, together with its subsidiaries, acquired approximately 5,445 bitcoins for approximately $147.3M in cash, at an average price of approximately $27,053 per bitcoin, inclusive of fees and expenses. As of September 24, 2023, MicroStrategy, together with its subsidiaries, held an aggregate of approximately 158,245 bitcoins, which were acquired at an aggregate purchase price of approximately $4.68B and an average purchase price of approximately $29,582 per bitcoin, inclusive of fees and expenses. As previously disclosed, on August 1, 2023 MicroStrategy entered into a Sales Agreement with Cowen and Company, Canaccord Genuity and Berenberg Capital Markets as sales agents, pursuant to which MicroStrategy may issue and sell shares of its class A common stock, par value $0.001 per share, having an aggregate offering price of up to $750.0 million from time to time through the Agents. On September 25, 2023, MicroStrategy announced that, as of September 24, 2023, MicroStrategy had issued and sold an aggregate of 403,362 Shares under the Sales Agreement for aggregate net proceeds to MicroStrategy of approximately $147.3M.
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CVGI | Hot Stocks10:41 EDT Commercial Vehicle Group opens manufacturing facility in Morocco - CVG announced the opening of its new manufacturing facility in Tangier, Morocco. This expansion represents CVG's commitment to its global electrification business growth and its first significant presence in Africa. The plant will initially offer approximately 30,000 square feet of manufacturing space and will produce electrical wire harnesses for the automotive industry. By 2024, CVG has plans to significantly increase the square footage with the capacity to produce hundreds of thousands of wire harnesses per year for additional industries including agriculture, construction, and more. This strategic location will serve as a pivotal hub in CVG's global network while supporting the local economy in Tangier. The facility will initially create 250 jobs, with greater job expansion planned in the future. CVG extends its gratitude to the Moroccan government and local authorities for their unwavering support throughout this venture.
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GOOG GOOGL | Hot Stocks10:20 EDT Google to discontinue Google Podcasts in 2024 - In a YouTube blog post, the company team said, " We're living in the golden age of podcasts. We've seen creators and artists really embrace Podcasts on YouTube, and its incredible potential to boost audience growth across audio and video formats. That's why, earlier this year, we launched the ability to watch and listen to podcasts on YouTube Music in the US, without requiring a paid membership. Podcasts on YouTube Music in the US already include access to downloads, background play in places like the car and on smart speakers as well as the ability to switch between audio and video podcasts. We plan to make Podcasts on YouTube Music globally available before the end of the year. Looking forward to 2024, we'll be increasing our investment in the podcast experience on YouTube Music - making it a better overall destination for fans and podcasters alike with YouTube-only capabilities across community, discovery and audio/visual switching. Later in 2024, as part of this process, we'll be discontinuing Google Podcasts. As part of this process, we'll be helping Google Podcasts users move over to Podcasts in YouTube Music. This matches what listeners and podcasters are already doing: according to Edison, about 23% of weekly podcast users in the US say YouTube is their most frequently used service, versus just 4% for Google Podcasts. We want to make sure we get this right and will give fans and podcasters plenty of time to make the transition. For users, it means a simple migration tool and the ability to add podcast RSS feeds to their YouTube Music library, including shows not currently hosted by YouTube. For those who prefer a different listening platform, the tools will also include an option to download an OPML file of their show subscriptions, which they can upload to an app that supports their import. For podcasters, this means providing robust creation and analytics tools, as well as RSS uploads, in addition to making your podcasts available everywhere YouTube Music listeners are already consuming their favorite content-in the background, in the car, offline, and more." Reference Link
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JPM | Hot Stocks10:08 EDT JPMorgan reaches $75M settlement with U.S. Virgin Islands over Epstein - JPMorgan announced an agreement to pay the U.S. Virgin Islands $75M to settle a lawsuit alleging the bank aided Jeffrey Epstein's sex trafficking. "JPMorgan Chase believes this settlement is in the best interest of all parties. While the settlement does not involve admissions of liability, the firm deeply regrets any association with this man, and would never have continued doing business with him if it believed he was using the bank in any way to commit his heinous crimes," the bank said in a statement.
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RGEN | Hot Stocks10:05 EDT Repligen to acquire Metenova AB, terms not disclosed - Earlier, Repligen Corporation announced that it has entered into a definitive agreement to acquire privately-held Metenova AB of Molndal, Sweden. Metenova is projected to generate revenues of $24M to $25M for fiscal year 2023, led by the success of its magnetic mixing and drive train technologies that are widely used by global biopharmaceutical companies and contract development and manufacturing organizations. "The company recently entered the single-use mixing market with the launch of its MixOne platform, leveraging the success of its existing stainless steel product line. Metenova is expected to contribute approximately $5 million in revenue to Repligen in the fourth quarter of 2023, and to contribute $25 million to $27 million in revenue in 2024, with 20%-25% revenue growth in 2025 forward. The acquisition is anticipated to be accretive to Repligen's adjusted gross and operating margins in 2024, and to be accretive to adjusted earnings per share in 2025," the company stated. The transaction is expected to be completed in the coming weeks, subject to the satisfaction of customary closing conditions. The transaction is a combination of cash and equity; to fund the cash component of the transaction, Repligen intends to use a portion of its cash on hand, which totaled approximately $604M at June 30, 2023.
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FZT | Hot Stocks10:04 EDT Fast Acquisition Corp II trading resumes
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EPAM MSFT | Hot Stocks10:04 EDT Epam Systems expands partnership with Microsoft - EPAM System is now a Microsoft globally Managed Enterprise Systems Integrator partner-helping to accelerate technology innovation, growth and business impact for enterprises through end-to-end solution design and implementation in the cloud. The newly acquired globally Managed Enterprise SI partner status marks a significant milestone in EPAM's expanding strategic partnership with Microsoft. The elevated status positions EPAM as a proven service provider for enterprise customers undertaking complex digital transformation, modernization and cloud migrations, and enables the Company to build cloud-native intelligent applications powered by Azure OpenAI Service.
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RGEN REGN | Hot Stocks10:03 EDT Correction: Repligen to acquire Metenova - This note corrects a prior alert that incorrectly stated in its headline that Regeneron had agreed to acquire Metenova AB.
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BAESY LMT | Hot Stocks10:01 EDT BAE Systems awarded five-year contract from Lockheed Martin - BAE Systems (BAESY) has received a five-year contract from Lockheed Martin (LMT) to sustain the AN/ALR-94 advanced digital electronic warfare system for the F-22 Raptor. Under the contract, BAE Systems will continue to manage EW system repairs and upgrades, supplier logistics, test equipment maintenance, and provide depot-level spares and engineering support to maintain F-22 EW readiness and relevancy for today's air dominance mission.
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GFOR | Hot Stocks10:00 EDT Graf Acquisition IV falls -8.3% - Graf Acquisition IV is down -8.3%, or -79c to $8.70.
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LABD | Hot Stocks10:00 EDT Daily S&P Biotech Bear 3x Shares falls -9.4% - Daily S&P Biotech Bear 3x Shares is down -9.4%, or -$2.04 to $19.64.
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UNFI | Hot Stocks10:00 EDT United Natural Foods falls -14.8% - United Natural Foods is down -14.8%, or -$2.80 to $16.12.
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HRTG | Hot Stocks10:00 EDT Heritage Insurance rises 8.4% - Heritage Insurance is up 8.4%, or 44c to $5.70.
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FSR | Hot Stocks10:00 EDT Fisker rises 11.0% - Fisker is up 11.0%, or 58c to $5.89.
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FTK | Hot Stocks10:00 EDT Flotek rises 471.8% - Flotek is up 471.8%, or $3.30 to $4.00.
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FZT | Hot Stocks09:59 EDT Fast Acquisition Corp II trading halted, volatility trading pause
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NMRD | Hot Stocks09:53 EDT Nemaura Medical appoints Nikolai Rozanov as strategic adviser in AI - Nemaura Medical announced the appointment of Nikolai Rozanov as strategic adviser in AI development. Rozanov is a specialist in the field of artificial intelligence and was selected for inclusion by Forbes magazine in their '30 Under 30' list in the field of technology. The company said, "The appointment of Mr Rozanov solidifies the Company's expertise in the growing AI sector, at a time when AI developments in healthcare are gathering pace. The Company is now well placed to further integrate data from its CGM to create tailored programs that can make tailored personalised recommendations."
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LABD | Hot Stocks09:47 EDT Daily S&P Biotech Bear 3x Shares falls -6.7% - Daily S&P Biotech Bear 3x Shares is down -6.7%, or -$1.45 to $20.23.
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LZM | Hot Stocks09:47 EDT Lifezone Metals falls -9.0% - Lifezone Metals is down -9.0%, or -$1.40 to $14.15.
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UNFI | Hot Stocks09:47 EDT United Natural Foods falls -20.0% - United Natural Foods is down -20.0%, or -$3.79 to $15.13.
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COOK | Hot Stocks09:47 EDT Traeger rises 4.6% - Traeger is up 4.6%, or 14c to $3.16.
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MEI | Hot Stocks09:47 EDT Methode Electronics rises 5.5% - Methode Electronics is up 5.5%, or $1.20 to $23.20.
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HRTG | Hot Stocks09:47 EDT Heritage Insurance rises 10.3% - Heritage Insurance is up 10.3%, or 54c to $5.80.
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LILM | Hot Stocks09:34 EDT Lilium starts assembly of Lilium Jet's electric propulsion system - Lilium is starting assembly of the Lilium Jet's electric propulsion system at its dedicated propulsion facility located next to its headquarters in Wessling, Germany. The announcement marks another exciting milestone on the targeted path towards industrialization and commercial entry into service of the Lilium Jet and reconfirms Lilium's roadmap towards achieving first manned flight of the aircraft in late 2024.
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CMCSA | Hot Stocks09:31 EDT Comcast appoints Edward Zimmerman as president, Comcast Business - Comcast Corporation announced Ed Zimmermann has been named President of Comcast Business. Zimmermann will focus on driving continued long-term growth and strategic innovation for the $10B commercial services business unit. He succeeds Bill Stemper who transitions to Chairman Emeritus, Comcast Business. Most recently, Zimmermann served as CFO and Chief of Strategy for Comcast Business.
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KUKE | Hot Stocks09:25 EDT Kuke Music receives continued listing standard notice from NYSE - Kuke Music announced that on June 29, 2023, it received a notice from the New York Stock Exchange that it is no longer in compliance with the NYSE's continued listing standards set forth in Section 802.01B of the NYSE's Listed Company Manual due to the fact that the Company's average global market capitalization over a consecutive 30 trading-day period was less than $50 million and its shareholders' equity was less than $50 million. As set forth in the Notice, as of June 27, 2023, the 30 trading-day average global market capitalization of the Company was approximately $20.7 million and the Company's last reported shareholders' equity as of December 31, 2022 was $8.8 million. In accordance with the NYSE's listing requirements, the Company has notified the NYSE that it will submit a plan within 45 days of the Notice advising the NYSE of the definitive action it has taken, or is taking, to bring it into conformity with Section 802.01B within 18 months of receipt of the Notice.
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SHOT | Hot Stocks09:24 EDT Safety Shot appoints jack Brewer to advisory board - Safety Shot Holdings announced that The Honorable Jack Brewer, M.Ed. has joined the Company's Advisory Board. Brewer is an ordained minister. Currently he is serving as CEO & Portfolio Manager of The Brewer Group, Inc.
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IPWR | Hot Stocks09:22 EDT Ideal Power adds global power conversion supplier to B-TRAN program - Ideal Power announced a European-based global power conversion and energy storage supplier with over $500 million in annual sales entered into an agreement with Ideal Power to test and evaluate B-TRAN power semiconductors for its static switches in data center UPS systems, solar inverters, and energy storage products. Their focus is on improving energy efficiency in these products to reduce operating costs for their customers.
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RNST | Hot Stocks09:21 EDT Renasant announces transfer of listing of common stock to NYSE - Renasant announced that the Company is transferring the listing of its common stock to the New York Stock Exchange from the NASDAQ Stock Market. Renasant's common stock is expected to begin trading on the NYSE on Monday, October 9, 2023, under its current ticker symbol: RNST. The Company's common stock will continue to trade on NASDAQ until the transfer is complete. "We're excited to list our common stock on the prestigious New York Stock Exchange," said Renasant CEO, Mitch Waycaster. "In joining the world's largest stock exchange, we believe NYSE will provide greater visibility for our company and shareholders. We look forward to celebrating this occasion and milestone for Renasant by ringing The Closing Bell(R) on our first day of trading on the NYSE."
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MTTR | Hot Stocks09:20 EDT Matterport announces next generation of AI-powered real estate insights - Matterport introduces the next generation of intelligent digital twins with powerful new capabilities fueled by the company's rapid advancements in AI and data science. Now in beta, customers can access automated measurements, layouts, editing, and reporting capabilities generated from their digital twins. "I'm excited to see the progression of our digital twins helping customers put AI and automation to practical use for their properties," said RJ PIttman, Chairman and CEO of Matterport. "Instant access to room dimensions, total square footage by room, floor, and the entire space, builds upon one of our most popular features - Measurement Mode. With our new intelligent digital twins, our customers get hundreds of useful measurements, room names, print-ready layouts and more - automatically. With these new 'power tools' we're driving customer productivity through the roof!"
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WISH | Hot Stocks09:19 EDT ContextLogic announces partnership agreement with PUDO - ContextLogic announced a partnership agreement with North American parcel pick-up and drop-off counter Network, PUDO. The partnership will allow Wish consumers to click and collect parcels from more than 1,200 PUDOpoint counters across the U.S. and Canada. "Through our collaboration with PUDO Inc., we're enhancing the shopping experience for our customers," said Bill Zhang, VP of Global Logistics and China GM at Wish. "The partnership amplifies convenience by enabling hassle-free package retrieval from numerous locations. In parallel, it also opens up new avenues for independent retailers to drive increased foot traffic and revenue streams generated by package collections. Our continued commitment to innovation and customer satisfaction is driving us to expand Wish Local's pick-up network to 24,000 points globally by year-end," concluded Zhang.
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BLNK | Hot Stocks09:18 EDT Blink Charging advances almost 2% after announcing deal with Parkopedia - Shares of Blink Charging, "a global manufacturer, owner, operator and provider of electric vehicle charging equipment and services," are up almost 2% to approximately $3.03 per share in the pre-market on Tuesday after announcing a deal with Parkopedia, "a global connected car and parking services provider," to integrate over 4,000 Blink EV charging locations onto the Parkopedia platform in North America. "Our collaboration with Parkopedia creates a streamlined experience for EV drivers to conveniently locate Blink EV charging stations across North America," said Jim Nemec, Chief Revenue Officer for Blink Charging. "The combination of Parkopedia's excellence in serving drivers through convenience in parking accessibility and Blink's extensive range of public EV chargers gives EV drivers confidence in finding a reliable charging experience wherever they are. This initiative builds upon our strategy of making it easy for EV drivers to locate Blink chargers through a variety of platforms."
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LUMO | Hot Stocks09:18 EDT Lumos Pharma announces new data, analysis of patient from OraGrowtH212 trial - Lumos Pharma announced that an analysis of interim data from its OraGrowtH212 Trial was given as an oral presentation at the 2023 annual meeting of the European Society for Paediatric Endocrinology, held in The Hague, Netherlands, September 21-23, 2023. The oral presentation, Deconvolution Analysis: Oral GH secretagogue enhances growth in individuals with moderate Pediatric Growth Hormone Deficiency by enhancing endogenous GH secretion and increasing IGF-1, was given in a late breaking session. The objective of the analysis was to characterize growth hormone profiles, defined by deconvolution analysis, based on the GH concentration sampled over 12 hours at baseline and after 6 months of therapy with daily oral LUM-201 to illustrate how LUM-201 increases annualized height velocity, total GH secretion, and serum IGF-1 and IGFBP3 in individuals with moderate PGHD. Fifteen prepubertal, naive moderate PGHD subjects were screened with a predictive enrichment marker test to assess their acute response to oral LUM-201, with a positive test having a peak GH greater than or equal to5 ng/ml with a basal IGF-1 greater than30 ng/ml. At baseline, subject were aged 7.9+/-1.4 years, with IGF-1 SDS -0.82+/-0.9, and peak GH 7.2+/-2.2 ng/mL, consistent with moderate PGHD. Deconvolution analysis was performed on serum GH measured every 10 minutes. Patients were randomized to receive 1.6 mg/kg/day or 3.2 mg/kg/day of oral LUM-201. Both baseline characteristics and acute GH responses to the PEM test and the day 1 PEM test doses were not different between the groups. The groups were therefore combined in this analysis. Results showed that after 6 months of treatment with LUM-201, GH, IGF parameters, and AHV increased 60-80% from baseline.
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NWVCF POST | Hot Stocks09:17 EDT EnWave signs commercial license agreement with Michael Foods - EnWave Corporation has signed a commercial royalty-bearing license with Michael Foods. Michael Foods has also purchased a 10kW Radiant Energy Vacuum machine from EnWave after conducting product development research and development over the past several months. The License grants Michael Foods the right to produce certain products using REV technology in the United States of America and provides for an ongoing royalty stream tied to the commercial sales of any REV-dried products produced and sold by Michael Foods during the term. The License is the fifty-third active royalty-bearing agreement issued by EnWave.
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WOR | Hot Stocks09:15 EDT Worthington reveals company identities ahead of anticipated separation - Worthington Industries, Inc. (NYSE: WOR), a leading industrial manufacturing company, today announced the names and branding for the two companies resulting from the planned separation. Worthington Enterprises will include the Company's Building Products, Consumer Products and Sustainable Energy Solutions businesses. Worthington Steel will be the Company's Steel Processing business. The separation is expected to occur as early as December 2023, ahead of the originally projected timing of early 2024. The Worthington Enterprises name represents the organization's strong heritage, entrepreneurial spirit, and market-leading brands and innovative products that improve lives. Worthington Steel honors the legacy of the Company's history with a return to the original name of the steel processing business John H. McConnell founded in 1955. The icon is equally sharp-edged and smooth, alluding to the versatility of steel as a raw material and the role it will play in the energy transition. Both Worthington Enterprises and Worthington Steel will be headquartered in Columbus, Ohio.
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VVPR | Hot Stocks09:15 EDT VivoPower's Tembo signs definitiev joint venture agreement with Francisco Motor - Tembo, a subsidiary of the NASDAQ listed B Corp, VivoPower International, announces that it has signed a definitive joint venture agreement with Francisco Motor, the pioneering manufacturers of the iconic jeepneys in the Philippines, which are primarily used for public transportation. Pursuant to the Agreement, Tembo will develop and supply electric utility vehicle electrification kits for a new generation of electric jeepneys. Francisco Motors and Tembo have already secured their first orders and have commenced work to deliver on these jeepneys. Kevin Chin, VivoPower's Executive Chairman and Chief Executive Officer, said: "We are honoured to have signed this exclusive definitive agreement with Francisco Motor Corporation to electrify the jeepneys, a much-loved cultural icon in the Philippines. Francisco Motors are the original pioneers of the jeepney, launching in 1947 post the ending of World War II. We stand in solidarity with Elmer Francisco, Chairman of Francisco Motors, in our shared mission to electrify and rejuvenate the jeepney in a manner that preserves the original design and look, as well as importantly improves the livelihood of the people employed by the jeepney industry.
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XBIT | Hot Stocks09:14 EDT XBiotech announces enrollment completion of Phase I trial for Hutrukin - XBiotech announces that Hutrukin is being developed by XBiotech as a breakthrough therapy to reduce brain injury after stroke. The last subject in a randomized, open-label, placebo-controlled Phase I dose escalation clinical study has been enrolled. XBiotech discovered, manufactures, and is conducting this clinical study of Hutrukin. The primary objective of the Phase I study is to evaluate safety and pharmacokinetics of Hutrukin in healthy volunteers. Sequential dose escalation was conducted using three cohorts of subjects, each receiving a single intravenous infusion of either placebo or Hutrukin, with eight subjects in each cohort.
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MCHP | Hot Stocks09:14 EDT Microchip releases PIC18-Q20 family of microcontrollers - With the step-function increase in data collected and transmitted from cloud-connected edge nodes, Improved Inter Integrated Circuit is rapidly becoming a more sustainable solution for interfacing sensors with a high data rate and will help expand capabilities in next-generation devices. Leading the way in I3C integration, Microchip Technology has released its PIC18-Q20 family of microcontrollers, the industry's first low pin count MCUs with up to two I3C peripherals and Multi-Voltage I/O. Available in 14- and 20- pin packages as small as 3 x 3 mm, the PIC18-Q20 MCUs are a compact solution for real-time control, touch sensing and connectivity applications. The MCUs offer configurable peripherals, advanced communication interfaces and easy connection across multiple voltage domains without external components.
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INTA | Hot Stocks09:12 EDT Intapp selected by Mayer Brown to improve collaboration - Intapp announced that global law firm Mayer Brown has selected Intapp Workspaces to modernize and improve collaboration. Intapp Workspaces will help manage the firm's Microsoft Teams governance, workspace provisioning, matter lifecycle management, and client collaboration. "We're excited to help Mayer Brown, one of the leading law firms in the world, achieve its strategic objectives around collaboration and usher in the next generation of work," said Pat Archbold, General Manager, Collaboration & Content at Intapp.
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CTRM | Hot Stocks09:12 EDT Castor announces sale of M/V Magic Argo, termination of sale of M/V Magic Moon - Castor Maritime announces that on September 22, 2023, the Company entered into an agreement with an unaffiliated third party for the sale of the M/V Magic Argo, a 2009-built Kamsarmax bulk carrier, for a price of $15.75 million. The vessel is expected to be delivered to her new owners during the fourth quarter of 2023.The Company expects to record during the fourth quarter of 2023 a net gain of approximately $3.0 million, excluding any transaction-related costs. The Company also announces that the previously announced sale of the M/V Magic Moon was terminated following the buyer's failure to take delivery of the vessel. Accordingly, the Company will retain the vessel and not receive its purchase price of $13.95 million, that would have incorporated a net gain before transaction costs of $5.3 million. The Company is seeking appropriate compensation pursuant to the terms of the Memorandum of Agreement for this sale.
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NUZE | Hot Stocks09:10 EDT NuZee expands supply agreement with existing customer - NuZee announced an expanded relationship with one of its largest customers, received a forecast for shipments from the customer, and agreed to begin supplying additional products to the customer starting in Q1 and Q2 of FY24. Revenues from this customer for the first nine months of FY23 totaled approximately $427K. The non-binding forecast provided by the customer for 2024 would result in over $2M in incremental fiscal year gross revenue to NuZee, if achieved, including both existing and new products. The new products primarily include bagged coffee, which is currently being produced for this customer by other suppliers.
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SDOT | Hot Stocks09:10 EDT Sadot reports topline revenue over $67M in August - Sadot Group has achieved top line revenue of over $67.8 million for the month of August 2023. This announcement marks the tenth consecutive month in which top line revenue has exceeded $45 million and comes on the heels of the Company's first-ever profitable quarter. "With the Company's strategic pivot into the global agri-foods supply chain sector ten months ago, we have been laser-focused on executing against our growth strategies across all facets of our business, including operational verticals and geographical areas of operations," said Sadot Group CEO, Michael Roper. "It is important to note that August's top line results includes our first trades in the Americas from our newly-formed subsidiary, Sadot Latam LLC."
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BL | Hot Stocks09:08 EDT BlackLine appoints Mary Ainsworth as Chief People Officer - BlackLine has appointed Mary Ainsworth as Chief People Officer, effective Sept. 5th. Ainsworth has more than 15 years of experience, most recently as EVP and Chief People Officer at Medallia. Before that, she served as EVP and Chief People Officer at CallidusCloud. Previously, Ainsworth worked at Robert Half International where she managed strategic recruiting efforts for both public and private companies.
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WMT | Hot Stocks09:08 EDT MobileX announces multi-year exclusivity agreement with Walmart - MobileX announced a multi-year exclusivity agreement with Walmart. MobileX first introduced customized prepaid mobile plans in February 2023 which will now be available on walmart.mymobilex.com and in select stores nationwide.
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PPG | Hot Stocks09:08 EDT PPG and Flo-Optics in pact 'for first digitally applied optical coatings' - PPG announced an exclusive supplier agreement with Flundefined-Optics, a developer of digital manufacturing technology for the ophthalmic industry, for the application of PPG HI-GARD scratch-resistant coatings using Flundefined's proprietary digital printing technology. "Pairing PPG's coatings expertise with Flundefined's breakthrough manufacturing technology opens the door to completely transform the way optical products are designed and developed into future-ready solutions" The agreement will enable the first ever digitized lens coating solutions using additive manufacturing , or 3D printing, technology. The digitized process will enable ophthalmic labs to apply coatings to lenses with precision for a customizable production method that allows for lenses with unique performance capabilities. In addition to allowing lenses to be more functional, the process makes lens coating more efficient, reducing material consumption, lowering production energy requirements and offering faster turnaround times compared to traditional application methods.
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VRA | Hot Stocks09:07 EDT Vera Bradley announces 2024 annual outlet sales date - Vera Bradley will host its 38th Annual Outlet Sale event at the Allen County War Memorial Coliseum in Fort Wayne, Ind. from May 1 - May 5, 2024. The first three days of the Vera Bradley Annual Outlet Sale will offer multiple ticketed sessions for shoppers to take advantage of the best selection of Vera Bradley handbags, travel items, accessories, stationery and luggage in a variety of current and retired patterns along with bracelets and other items from VRA-owned lifestyle brand Pura Vida. The last two days of the Sale will be open to the public with no ticket required to enter.
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PLD | Hot Stocks09:06 EDT Prologis invests in TestFit - Prologis has deployed TestFit's real-time AI to help them better judge the feasibility of new warehouse sites. Prologis Ventures co-led in the Series A round with Parkway Venture Capital, which closed in June 2022, along with an additional investor, Perot Jain. TestFit's real estate feasibility platform provides insights into design, constructability, and costs in early-stage site planning, and historically has been the gold standard AI software for multi-family, working with 50% of the top 10 multi-family developers today. Prologis Ventures, the venture arm of the global leader in logistics real estate, has focused its investment strategy on innovative solutions that help solve the most critical pain points in areas such as operations, sustainability, energy and construction. Prologis has been piloting TestFit to give its teams real-time insights on design, evaluation of constructability, and forecasting of costs for new logistics sites.
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PRGS | Hot Stocks09:06 EDT Progress Software announces partnership with SIG - Progress announced a partnership with Software Improvement Group, SIG, an independent technology and advisory firm for software quality, security and improvement, to help ensure the long-term maintainability and modernization of business-critical applications built on the Progress OpenEdge platform. This collaboration provides OpenEdge customers with automated guidance through Sigrid, SIG's software assurance platform, on areas to focus on when addressing technical debt and modernizing applications. "Our partnership with SIG is important as it provides a unique opportunity to extend the value that OpenEdge provides by offering greater insight into the quality of the application code supporting mission-critical applications that our customers depend on," said John Ainsworth, Executive Vice President, General Manager, Application and Data Platform, Progress.
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BP XOM | Hot Stocks09:06 EDT BP starts construction on new Texas solar project - BP (BP) has started construction on its 187MWdc Peacock Solar project, located 10 miles north of Corpus Christi in San Patricio County, Texas, helping support the global transition to lower carbon energy. Peacock will sell all of the electricity it generates under a long-term power purchase agreement to Gulf Coast Growth Ventures, a joint venture between ExxonMobil (XOM) and SABIC, which produces materials used to manufacture clothes, food containers, packaging, agricultural film and construction materials. Located near the GCGV complex, Peacock will supply power directly to the facility. Once complete, the installation will generate enough renewable energy annually to power the equivalent of 34,000 homes. The project is expected to create around 300 jobs during construction and provide more than $25 million in tax revenue over the first 25 years of the project's life.
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CANO | Hot Stocks09:05 EDT Cano Health sells primary care centers in Texas and Nevada for $66.7M - Cano Health sold substantially all of the assets associated with the operation of Cano Health's senior-focused primary care centers in Texas and Nevada to CenterWell Senior Primary Care. The total value of the transaction to Cano Health is approximately $66.7M, consisting of approximately $35.4M in cash paid at closing, plus the release of certain liabilities owed by Cano Health. As of August 1, the primary care centers in Texas and Nevada cared for approximately 15,200 members. Cano Health expects that the net cash proceeds from this transaction will enable it to remain in compliance with the covenants under its debt instruments at the end of Q3. Following the transaction, Cano Health has available liquidity consisting of approximately $109M of unrestricted cash. Cano Health intends to use approximately $80M of such cash to repay a portion of its $120M revolving credit facility by the end of Q3 2023. This will enable Cano Health to remain below the $42M threshold drawn amount and thus avoid being required to comply with the financial maintenance covenant under its Credit Suisse credit agreement for the testing period ending September 30, 2023. The remaining balance will be available for general corporate purposes. The $80M of planned repayments under the revolving credit facility will remain available for future borrowings.
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NRXS | Hot Stocks09:05 EDT Neuraxis announces results of comparative study of IB-Stim - NeurAxis announced the results of a retrospective comparative study of adolescent patients with functional abdominal pain disorders, FAPD, treated with IB-Stim therapy or standard of care medications, amitriptyline or cyproheptadine. Led by the Cincinnati Children's Hospital Medical Center, the comparative study concluded that IB-Stim may be a good non-pharmacologic alternative for FAPD. The publication, Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders, featured in the September 19th 2023 Frontiers in Pain Research, reviewed records of 101 adolescents treated with 4 weeks of IB-Stim, amitriptyline or cyproheptadine. In the study, 59% of patients in the IB-Stim group had failed prior standard medical therapy. Evaluated outcome measures included validated pediatric questionnaires using Abdominal Pain Index, Nausea Severity Scale and Functional Disability Inventory at baseline and at 3-month follow up. The comparative analysis noted that: at follow up, IB-Stim therapy showed improvements in abdominal pain and functional disability compared to baseline, while amitriptyline showed improvements in abdominal pain; in a comparison of outcomes between groups, IB-Stim was more effective than cyproheptadine in improving abdominal pain and did not differ from amitriptyline. Nausea scores did not differ between groups; and disability scores between groups were only more effective for amitriptyline vs. cyproheptadine. Disability scores did not differ from amitriptyline compared with IB-Stim.
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JKHY | Hot Stocks09:05 EDT Jack Henry, Marstone team on seamless access to digital wealth & banking - Marstone announced its collaboration with Jack Henry. The partnership allows bank customers who use Jack Henry's Banno digital banking platform to also access Marstone's digital wealth platform via a single sign-on SSO . Marstone leveraged the Banno Digital Toolkit the same set of APIs the Banno Digital Platform is built on, to embed its technology into the digital experiences offered by community and regional financial institutions. Access to Jack Henry's API, design and authenticated frameworks has enabled Marstone to directly integrate into the digital banking platform, providing a seamless banking experience. This integration has contributed to Jack Henry's growing ecosystem of more than 850 fintechs, providing nearly 8,000 financial institutions with relevant financial products and services for their account holders.
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AVGO... | Hot Stocks09:05 EDT Broadcom partners with Google Cloud for cybersecurity - Symantec is partnering with Google Cloud to embed generative AI into the Symantec Security platform in a phased rollout that will give customers a significant technical edge for detecting, understanding, and remediating sophisticated cyber attacks. Symantec is leveraging the Google Cloud Security AI Workbench and security-specific large language model--Sec-PaLM 2-across its portfolio to enable natural language interfaces and generate more comprehensive and easy-to-understand threat analyses. With Security AI Workbench-powered summarization of complex incidents and alignment to MITRE ATT&CK context, security operations center analysts of all levels can better understand threats and be able to respond faster. That, in turn, translates into greater security and higher SOC productivity.
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GOVX | Hot Stocks09:04 EDT GeoVax secures multi-product license for ProBioGen's AGE1.CR.pIX line - GeoVax Labs and ProBioGen announce the signing of a landmark commercial license agreement for ProBioGen's groundbreaking AGE1.CR.pIX suspension cell line. The agreement will empower GeoVax to enhance the manufacturing capabilities of its entire Modified Vaccinia Ankara based vaccine portfolio. ProBioGen's AGE1.CR.pIX suspension cell line is an innovative and proven platform that enables high-yield and scalable production, ensuring efficient industrial manufacturing processes. This translates to cost-effectiveness and increased productivity for vaccine developers. The AGE1.CR.pIX cell line's versatility allows it to support a wide range of viruses and vaccine types, enhancing its suitability for various vaccines in development and as a replacement for traditional production systems. Additionally, AGE1.CR.pIX's robust growth and genetic stability ensure consistent and reliable production, leading to the delivery of safe and effective vaccines. MVA grows particularly well on this cell line, making it even more advantageous for vaccine development. By leveraging this modern production technology, GeoVax aims to accelerate the manufacturing of its entire vaccine pipeline. This multi-product license represents a strong commitment to improving global access to life-saving vaccines. Financial terms of the commercial license to use the AGE1.CR.pIX, including potential clinical milestones and future royalties were not disclosed.
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TBLA | Hot Stocks09:03 EDT Taboola announces multi-year deal with Advance Local - Taboola announced a multi-year deal with Advance Local, a Taboola partner since 2015. Under the agreement, Advance Local will utilize Taboola's suite of products to grow its audience, optimize user engagement, and drive revenue. Advance Local will incorporate Taboola Feed. In addition to Taboola Feed, Advance Local will implement Taboola in additional high-impact user touchpoints, such as mid-article and right rail placements. "I'm honored that Advance Local is trusting us long-term to grow their audiences, and this move into e-commerce is especially exciting as they continue to look for new ways to provide value to their readers," said Adam Singolda, Founder and CEO at Taboola. "We're looking forward to this continued partnership and helping Advance Local power their success in a holistic way."
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SNPX | Hot Stocks09:03 EDT Synaptogenix's Bryostatin-1 in Alzheimer's featured in peer-reviewed publication - Synaptogenix announced a peer-reviewed publication of statistically significant integration of secondary and exploratory endpoint data from its previously completed Phase 2 trial of Bryostatin-1 for Alzheimer's disease. As stated in the paper, conclusions from analyses of the trial's Severe Cohort indicate that Bryostatin-treated MMSE 10-14 patients showed no significant cognitive decline throughout the 10-month trial, compared with placebo patients' decline of -12.8 SIB points. The paper goes on to discuss persistence in the data, stating, "The prolonged absence of any significant cognitive decline in Bryostatin-treated patients vs. placebo patients - even 16 weeks after the final dose of Bryostatin - suggests a long-lasting positive change in the treated patients' brains." The data demonstrates that Bryostatin-1-treated patients in the Severe Cohort showed statistically significant improvement of cognitive performance over placebo patients for weeks #13 through #42, with the last dose administered at Week #26.
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BIIB RETA | Hot Stocks09:03 EDT Biogen completes acquisition of Reata Pharmaceuticals - Biogen (BIIB) has completed the acquisition of Reata Pharmaceuticals (RETA). As a result of the transaction, Biogen has now acquired SKYCLARYS, as well as other clinical and preclinical pipeline programs. "By adding a highly complementary product in an area of significant unmet medical need to our portfolio, we believe the acquisition of Reata aligns with our strategy to serve patients, drive sustainable growth and create significant shareholder value," said Christopher A. Viehbacher, President and Chief Executive Officer at Biogen. "With the transaction now complete, we look forward to leveraging Biogen's rare disease expertise and capabilities to work together with our Reata colleagues as one team to bring SKYCLARYS to patients living with this devastating disease." Biogen anticipates significant synergies with its existing rare disease portfolio and plans to update its Full Year 2023 Financial Guidance in conjunction with its third quarter 2023 earnings release. The acquisition of Reata is expected to be slightly dilutive to Biogen's Non-GAAP diluted Earnings Per Share in 2023, roughly neutral in 2024, and significantly accretive beginning in 2025, inclusive of associated transaction costs.
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GLXZ CCL | Hot Stocks09:02 EDT Galaxy Gaming delivers operating system across Carnival fleet - Galaxy Gaming announced that they will deliver Galaxy Operating System as the table games system for 50+ ships across the globe with Carnival Corporation & plc. Already live on over 20 ships, GOS will power the jackpot progressive system for Carnival Corporation ships, including Carnival Cruise Line, Holland America Line, and Princess Cruises.
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FMCC | Hot Stocks09:00 EDT Freddie Mac sells $586M in NPLs - Freddie Mac sold via auction 3,564 non-performing residential first lien loans from its mortgage-related investments portfolio. The loans, with a balance of approximately $586 million, are currently serviced by Specialized Loan Servicing LLC, Select Portfolio Servicing, Inc., NewRez LLC, d/b/a Shellpoint Mortgage Servicing and Nationstar Mortgage LLC d/b/a RightPath Servicing. The transaction is expected to settle in November 2023. The sale is part of Freddie Mac's Standard Pool Offerings. Freddie Mac, through its advisors, began marketing the transaction on August 28, 2023 to potential bidders, including non-profits and Minority, Women, Disabled, LGBT, Veteran or Service-Disabled Veteran-Owned Businesses, neighborhood advocacy organizations and private investors active in the NPL market. Bids for the upcoming Extended Timeline Pool Offering, which is a smaller sized pool of loans, are due from qualified bidders by October 19, 2023. For the SPO offerings, the loans were offered as two separate pools of mortgage loans. The two pools consist of mortgage loans secured by geographically diverse properties. Investors had the flexibility to bid on each pool individually and/or any combination of pools.
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UBLXF | Hot Stocks08:59 EDT U-Blox announces LEXI-R10 module - u-blox has announced its LEXI-R10, an ultra-small LTE Cat 1bis IoT module in a 16 x 16mm form factor. The module adapts perfectly to size-demanding designs, making it ideal for use cases such as asset tracking and aftermarket telematics. Three times smaller than the u-blox LENA-R8, LEXI-R10 is the answer to the market need for an ultra-small LTE Cat 1bis module and is the perfect candidate for applications requiring Cat 1bis connectivity without 2G fallback or positioning features. It has been designed as a single-mode LTE-only module. Yet, LENA-R8 is still a reliable option for applications that need 2G fallback and positioning with the embedded u-blox M10 GNSS platform.
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NRC | Hot Stocks08:58 EDT NRC Health expands partnership with Lurie Children's - NRC Health announce that Lurie Children's Hospital of Chicago has expanded their long-time partnership to include NRC Health's Market Insights, the nation's most comprehensive and longest-running syndicated study of consumer perceptions in healthcare. As a valued partner utilizing NRC's patient experience technology and expertise, Lurie Children's has expanded their relationship to better understand their patients and the broader communities they serve. "Lurie Children's has a recognized commitment to understanding and continuously improving the experience for their patients and families," said Helen Hrdy, NRC Health's Chief Growth Officer. "By expanding their partnership to include Market Insights, they are demonstrating their passion to deepen their understanding of the communities they serve. We are honored to be their partner of choice."
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AYRO | Hot Stocks08:58 EDT Ayro to host test drive event at Texas headquarters - AYRO announces that the Company will host an exclusive opportunity for individuals to drive the Company's utility low-speed electric vehicle, the AYRO Vanish at the Company's headquarters in Round Rock, Texas on October 19, 2023. The Vanish offers adaptable payloads to meet a myriad of needs for fleet, commercial and personal use. The Vanish recently completed California Air Resources Board testing certification, and has also completed homologation for both the United States and Canada by demonstrating compliance with Federal Motor Vehicle Safety Standards, Canada Motor Vehicle Safety Standards and SAE J2358. The Vanish is currently in low-rate initial production with availability of the vehicle for dealers and partners expected to follow shortly.
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CEI | Hot Stocks08:57 EDT Camber Energy announces shipment of 3.5MW SImson-Maxwell custom genertor - Camber Energy announces that Simson-Maxwell, a majority-owned subsidiary of Viking Energy Group, Camber's wholly-owned subsidiary, recently shipped a 3.5 MW - SGW3505, Simson-Maxwell customized generator destined for Iqaluit, the capital city of Nunavut, the largest and northernmost Territory of Canada. The SGW3505 will replace an older unit within an existing power plant managed by Qulliq Energy Corporation and assist with providing safe, reliable power to the City of Iqaluit, an important northern center in Canada. It is anticipated the SGW3505 will allow Qulliq Energy Corporation to experience fuel economy and emissions savings, as well as lower overall maintenance costs. The Iqaluit power plant also has other older engines which Simson-Maxwell hopes to replace in the same fashion at the appropriate time. This particular order was placed in October 2022 and shipped by Simson-Maxwell the week of September 18, 2023, as planned.
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ONDS | Hot Stocks08:55 EDT Ondas' Airobotics completes Optimus Drone Infrastructure PoC program - Ondas Holdings' Airobotics has successfully completed a proof-of-conceptof the Optimus Drone Infrastructure in the Haifa port area. The PoC was conducted with the Israel Port Company, which is responsible for planning, development, construction, maintenance, and enhancement of Israel's commercial seaports in Haifa, Ashdod, and Eilat. With the successful completion of the PoC, Airobotics and IPC will be working on advancing the deployment of Optimus in the Haifa port area.
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BREA | Hot Stocks08:55 EDT Brera announces its Mozambique football team won the Province of Maputo title - Brera announced that its Mozambique football team, Brera Tchumene FC, won the Province of Maputo title, ending a sensational run in the Provincial II Divisao Championship. Brera's sole African team finished in first place with 40 points in 16 games, winning 13, losing two, and tying one. Brera Tchumene FC scored 68 goals and allowed just seven, with an amazing goal difference of +61. Desportivo daMatola, which finished the Maputo Championship as runner-up with 34 points, scored 35 goals with a goal difference of +31. The team is now preparing for the start of the Promotion Pool which begins September 30, 2023.
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VEV | Hot Stocks08:54 EDT Vicinity Motor receives order for four Vicinity Classic buses - Vicinity Motor announced the receipt of a new purchase order from the Village of New Square, New York for four Vicinity Classic buses. Per the terms of the supply agreement, the Village of New Square has ordered four of the Company's 32-foot Clean-Diesel Vicinity Classic buses for delivery in the fourth quarter of 2023. The Vicinity buses will service New Square, a village north of New York City, providing enhanced mobility solutions through the low-floor design - which includes an automatic personal mobility aid access ramp for wheelchairs.
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SBET | Hot Stocks08:53 EDT SharpLink cleared in Kentucky to offer online sports betting conversion - SharpLink Gaming announced that the Company is cleared by Kentucky to offer online sports betting conversion solutions to sports media operators, leagues, teams and sportsbooks also licensed to operate in the state. Kentucky became the 37th state in the nation to legalize sports betting with the signing of HB 551 into law on March 31, 2023 - and is the 29th jurisdiction in the U.S. and Canada in which SharpLink has been legally cleared to operate, marking another critical inflexion in the Company's national expansion plans. Legal in-person sports betting began in Kentucky on Thursday, September 7, 2023 and online sports betting becomes legally effective this Thursday, September 28, 2023.
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OSS | Hot Stocks08:52 EDT One Stop Systems secures award for submarine sonar data processing system - One Stop Systems has received an order to design and develop prototypes for a sonar data processing system to be used in a foreign navy submarine application. "We are pleased to be recognized in this award for our unmatched ability to deliver a ruggedized edge processing solution with datacenter class processing within strict SWAP, thermal and noise requirements," stated OSS CEO Mike Knowles. "The win also reflects our progress in leveraging OSS Europe to expand our global reach and customer base." OSS will design and build a liquid-cooled high-performance compute solution that will be deployed on submarines. OSS expects to deliver the first prototypes by the end of the year, followed by potential production orders in 2024.
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JAGX | Hot Stocks08:51 EDT Napo Pharmaceuticals provides fiscal support for ACE survey - In an effort to shed light on the diverse and profound challenges faced by individuals living with a diagnosis or a history of cancer, Napo Pharmaceuticals, a Jaguar Health family company, announced they were proud to provide fiscal support for "More Than a Diagnosis: A Quality of Life Survey for Individuals with a Diagnosis or History of Cancer." The online, anonymous survey was an initiative of Advocates for Collaborative Education. The survey received over 500 responses and will offer a unique perspective on the experiences and priorities of those affected by cancer. "While cancer treatments have advanced considerably since the advent and availability of targeted therapies, significant short- and long-term treatment side effects can be challenging or even devastating to an individual's quality of life," said Advocates for Collaborative Education founder Stacey Tinianov, MPH. "Our goal was to move beyond progression-free survival and overall survival statistics to quantify quality-of-life impacts across a large sampling of individuals with a diagnosis or history of cancer. We were thrilled to have Napo's support and hope these findings will inform research, clinical care, and the broader cancer community on what matters most to individuals and, potentially, how best to address quality-of-life impacts through improvements in supportive care."
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PTIX | Hot Stocks08:49 EDT Protagenic Therapeutics initiates Phase I/IIa trial for PT00114 - Protagenic Therapeutics has announced the commencement of its Phase I/IIa clinical trial for PT00114, its leading drug candidate. Key Highlights: Clinical Trial Focus: The trial aims to evaluate the therapeutic potential of PT00114, a synthetic version of the naturally occurring brain peptide TCAP, in treating an array of neuro-psychiatric conditions, including depression, anxiety, and PTSD. PT00114 is a novel first in class peptide which has shown profound activity with a novel mechanism in disease models of those three conditions, as well as in treating models of addiction withdrawal. Study Design: Phase I will recruit 56 subjects, randomized to undergo subcutaneous injections of either PT00114 or a placebo. The Phase I/IIa study will assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder. Progress Indicators: Besides monitoring disease status, the trial will gauge disease response by measuring biomarkers, such as circulating cortisol levels before and after treatment. Partnership: Axiom Real-Time Metrics, a CRO/Data Analytics firm with over 1,000 clinical trials to its credit, is managing the clinical program.
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CETX | Hot Stocks08:48 EDT Cemtrex receives $1M contract from Pennsylvania Borough Stewartstown - Cemtrex has received a $1.0M order through its subsidiary, Advanced Industrial Services, AIS, for the Pennsylvania Stewartstown Borough Authority, Stewartstown WWTP Sludge Dewatering improvements project. The project includes, but it not limited to, removing, and replacing the existing boiler, unit heaters, sludge pump, sludge piping, sludge belt press, removing above ground tanks, and renovating the existing boiler room. The contract extends into 2024 and is a multi-trade project in which AIS will utilize internal employees to complete more portions of the project directly rather than subcontract work due to AIS' expanded service offerings. "This is our first project win following our acquisition of Heisey Mechanical, a leading service contractor and steel fabricator that specializes in industrial and water treatment markets," said Saagar Govil, Chairman and CEO of Cemtrex. "Now integrated with AIS, the company continues to provide the water treatment industry with a variety of fabricated vessels and equipment including ASME pressure vessels, heat exchangers, mix tanks, reactors, and other specialized fabricated equipment."
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ENSC | Hot Stocks08:48 EDT Ensysce Biosciences completes site initiation visit for PF614-201 study - Ensysce Biosciences announced the Site Initiation Visit was completed for the PF614-201 study, 'A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects' to evaluate time of onset for PF614. The study is being conducted by Dr. George Atiee at Dr. Vince Clinical Research in Overland, KS.
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EEIQ | Hot Stocks08:48 EDT EpicQuest Education signs agremeents with two Canadian educational institutions - EpicQuest Education's EduGlobal College signed a Memorandum of Understanding and Articulation Agreement with Corpus Christi College in Vancouver, Canada, and an Articulation Agreement with Academy of Learning, which has learning campuses throughout Canada. The agreements provide for ongoing collaborations between EduGlobal and the two institutions of higher learning. The purpose of the MOU and Articulation Agreement between EduGlobal and Corpus Christi College is to promote Corpus Christi's academic programs to students at EduGlobal and to facilitate admission and credit transfers for qualified international students from EduGlobal to an Associate of Arts Degree Program at Corpus Christi. The agreement commenced from August 1, 2023 and continues to August 1, 2027. The purpose of the Articulation Agreement between EduGlobal and Academy of Learning is to promote Academy of Learning's academic programs to students at EduGlobal and to facilitate admission and credit transfers for qualified international students from EduGlobal to certificate and diploma programs at Academy of Learning. The agreement commenced from July 15, 2023 and continues to July 15, 2025.
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STSS | Hot Stocks08:47 EDT Sharps sign asset purchase agreement to acquire InjectEZ manufacturing facility - Sharps Technology and Nephron Pharmaceuticals announce the signing of an Asset Purchase Agreement to acquire Nephron's InjectEZ specialty syringe manufacturing facility. This includes a 10-Year purchase agreement for over $400 Million from Nephron Pharmaceuticals for next-generation copolymer prefillable syringe systems. Product delivery is scheduled for the first quarter of 2024 with revenue totaling approximately $30 Million for the first twelve months of production and subsequent revenue of over $45 Million per year beginning in 2025, and continuing through 2033. s a result of the proposed acquisition of InjectEZ, Nephron has agreed to a 10-year Purchase Agreement for Sharps' next-generation copolymer prefillable 10 mL and 50 mL syringes with minimum orders for over $400 Million over the period. Product delivery is scheduled for the first quarter of 2024 with revenue totaling approximately $30 Million for the first twelve months of production, with subsequent revenue of over $45 Million per year beginning in 2025, and continuing through 2033. To finance the acquisition, Sharps retained Lampert Capital Advisors, a provider of complex financing solutions to publicly traded, privately held, and entrepreneurially backed companies. Lampert is engaged in a financing process that has resulted, to date, in a signed term sheet with a leading middle-market lender for up to $75 Million in debt financing to be used for the acquisition of InjectEZ, production line enhancements, working capital, transaction fees and expenses, and general corporate purposes.
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VERB | Hot Stocks08:46 EDT VERB's MARKET.live secures spot in TikTok Shop Fall Sale - Verb Technology Company has been invited to participate in the TikTok Shop Fall Sale. Taking place from October 6th to October 10th, with warm-up days on October 4th and October 5th, this event presents MARKET.live with the opportunity to leverage its recently announced technology integration and strategic relationship with global social media platform TikTok. The new technology integration allows MARKET.live sellers to stream simultaneously on TikTok and have their TikTok customers check-out directly on and through the TikTok app, creating a far more seamless, friction-free buying experience for TikTok users that prefer not to leave the app to complete a purchase. It also allows MARKET.live sellers to expand the addressable universe of buyers to the more than 150 million US-based TikTok users.
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WTER | Hot Stocks08:44 EDT Alkaline Water now In full compliance with NASDAQ's periodic filing requirement - The Alkaline Water Company announced it has received formal notification from The Nasdaq Stock Market that it is now in compliance with the Nasdaq's periodic filing requirements. Previous deficiency notifications received from The Nasdaq Stock Market on July 18 and August 23, 2023, and subsequently disclosed by the Company, have been fully remedied by the Company. "I am pleased the Company has remedied its filing deficiencies. Going forward, it is imperative that the Company timely file all of its periodic financial reports, and I have taken the necessary steps to ensure timely reporting going forward," stated Frank Chessman, President and CEO of The Alkaline Water Company.
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LIXT | Hot Stocks08:44 EDT Lixte Biotechnology appoints Bas van der Baan as President, CEO - LIXTE Biotechnology announced that Bas van der Baan has been named as President and Chief Executive Officer of the Company, and as Vice Chairman of the Board of Directors, effective as of September 26, 2023. He has been a member of LIXTE'S Board of Directors since June 2022. van der Baan succeeds John S. Kovach, M.D., 87, who founded the Company in 2005 and was named Executive Chairman. Dr. Kovach will continue as the Company's Chief Scientific Officer. Both Dr. Kovach and Mr. van der Baan will continue in their roles as members of the Board of Directors of LIXTE. van der Baan was most recently Chief Clinical and Business Development Officer of Agendia
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DDD | Hot Stocks08:43 EDT 3D Systems receives $10.8M contract award from U.S. Air Force - 3D Systems announced it has been awarded a $10.8M U.S. Air Force contract for a Large-format Metal 3D Printer Advanced Technology Demonstrator. The contract supports the development of large-scale hypersonic-relevant additive manufacturing print capabilities. Work will be performed in Rock Hill, South Carolina, and in San Diego, California with an expected completion date of September 29, 2025. This contract builds upon 3D Systems' history of working in support of the U.S. Department of Defense/Government since 2019 for the advancement of additive manufacturing. "We're pleased to have been awarded this contract and are confident that it will extend the state of the art in metal additive manufacturing within the United States," said Dr. Jeffrey Graves, president & CEO, 3D Systems. "We look forward to working with the United States Air Force to meet the objectives of this project."
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IMNN | Hot Stocks08:42 EDT Imunon releases enterprise video highlighting company's mission - IMUNON announced the release of an enterprise video that highlights the company's mission, vision, values, breakthroughs and technologies. The video, which can be viewed on IMUNON's newly relaunched website provides an overview of the company and its mission to develop innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases. It was filmed in large part during the unveiling of IMUNON's new current Good Manufacturing Practices facility in the Huntsville, Alabama campus of the AlphaHudson Institute for Biotechnology. The facility is intended to enhance IMUNON's control over the quantities and costs of manufacturing non-viral DNA-based materials used in its research and development activities. The video continues with a discussion of IMUNON's vision for the future of immunotherapy, its values of innovation, collaboration and patient-centricity, and its recent breakthroughs in the development of DNA-based vaccines and therapeutics. "We are proud to release our first-ever enterprise video to share our story," said Dr. Corinne Le Goff, president and chief executive officer of IMUNON. "It provides an excellent overview of our company as well as our vision for the future of immunotherapy. We believe that this video will help to raise awareness of our work and the potential of DNA-based immunotherapy to address some of the most challenging diseases facing humanity."
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ARCT | Hot Stocks08:42 EDT Arcturus and CF Foundation extend pact to advance ARCT-032 - Arcturus Therapeutics Holdings announced that Arcturus and the Cystic Fibrosis Foundation CF Foundation have extended their ongoing agreement. The CF Foundation agreed to increase its financial commitment to ~$25M to advance ARCT-032, a novel messenger RNA mRNA therapeutic candidate formulated with Arcturus' LUNAR delivery technology. This agreement extends a prior research program, initiated in 2017, which has resulted in the advancement of ARCT-032 into ongoing clinical studies. "We are thrilled to extend our productive relationship with the Cystic Fibrosis Foundation, and we are grateful for their meaningful financial support," said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus. "ARCT-032 has the potential to express fully functional CFTR protein in the lung, thereby addressing the root cause of cystic fibrosis. The resources and valuable expertise provided by the CF Foundation will support the continued clinical development of ARCT-032, including the completion of a Phase 1b study that we plan to initiate imminently in adults living with cystic fibrosis."
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VERU | Hot Stocks08:41 EDT Veru reaches agreement with FDA on Phase 3 trial for sabizabulin - Veru announced that in a September 21, 2023 meeting, the Company and FDA reached agreement on the design of a new Phase 3 clinical trial study to evaluate sabizabulin plus standard of care treatment in an expanded patient population, hospitalized adult patients who have broadly any type of virus causing ARDS. The Phase 3 study may suffice as a single study for NDA submission. FDA agreed to a Phase 3, randomized, multicenter, placebo-controlled, parallel group design study to evaluate the efficacy and safety of sabizabulin 9mg oral daily dose plus standard of care treatment versus placebo plus standard of care treatment in hospitalized adult patients with any type of virus inducing ARDS: Novel indication for sabizabulin has been expanded to include all hospitalized adult patients with any type of viral induced ARDS. Endpoints: Primary efficacy endpoint is all-cause mortality at day 60; Secondary endpoints include days in the hospital, days in the ICU, days on mechanical ventilation, and proportion of patients alive without respiratory failure; Given the high mortality rate for viral induced ARDS, the expected size of the study is 408 patients; If Phase 3 study were to demonstrate sufficient benefit on all-cause mortality at Day 60, then this study could potentially be sufficient for NDA submission; As the program has FDA Fast Track designation, a rolling NDA submission is a possibility for sabizabulin.
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SPWH | Hot Stocks08:40 EDT Sportsman's Warehouse appoints Stone as CEO, McBee as next independent chair - Sportsman's Warehouse announced that its Board of Directors has appointed Paul Stone as the Chief Executive Officer and President of the Company and as a member of the Board, effective November 1, 2023. Stone's appointment follows an extensive search and selection process that considered both internal and external candidates. This process was led by the Board and conducted with the assistance of a leading independent executive search firm. Stone will succeed Joseph Schneider, who has served as Interim Chief Executive Officer and President since April 2023. Schneider will continue to serve as Independent Chair of the Board until the end of 2023, when he will retire from the Board and director Rich McBee will succeed him as Independent Chair. Stone is a seasoned executive with direct experience in the outdoor specialty retail space, having served as the Chief Retail Officer of Cabela's. Richard McBee has served as a member of the Sportsman's Warehouse Board since November 2018.
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DYAI | Hot Stocks08:38 EDT Dyadic International, bYoRNA SAS enter development, commercialization agreement - Dyadic International and bYoRNA SAS announced that they entered into a development and commercialization agreement to work on disruptive bioproduction technologies that will help exploit the therapeutic potential of messenger RNA. "I am excited to announce this development and commercialization agreement to explore the potential to utilize our C1 protein production platform to produce high-quality messenger RNA products at lower cost which will be easier to manufacture than in vitro mRNA, making it accessible to everyone, including patients from poorer countries. The global mRNA vaccine and therapeutics market was valued at USD 34.7 billion in 2022 and is expected to reach USD 68.1 billion by 2030, making this an extremely valuable potential opportunity for both companies to enter the rapidly expanding market for mRNA-based vaccines and therapies, said Mark Emalfarb, Dyadic's Chief Executive Officer. "If this collaboration is successful, Dyadic has the potential to receive certain defined milestone and royalty payments from bYoRNA and the ability to obtain a license to the BRNA platform," Emalfarb concluded.
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RTX | Hot Stocks08:38 EDT RTX to expand GTF MRO capacity in Singapore - Pratt & Whitney, an RTX business, announced plans to increase the capacity of its Singapore engine center, Eagle Services Asia. The 48,000 square-foot expansion will accommodate a two-thirds increase from current facility capacity.
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INM | Hot Stocks08:36 EDT InMed Pharmaceuticals discloses Nasdaq non-compliance - In a regulatory filing yesterday, InMed Pharmaceuticals stated: "On September 19, 2023, the Company received written notice from the listing qualifications department staff of The Nasdaq Capital Market notifying it that the average closing bid price of the Company's common shares over a period of 30 consecutive trading days was below the minimum $1.00 per share requirement for continued listing on the Nasdaq under Nasdaq Listing Rule 5550(a)(2). In accordance with applicable Nasdaq procedures, the Company has a period of 180 calendar days following the receipt of the written notice mentioned above to cure the deficiency and regain compliance. The notice has no immediate impact on the listing of the Company's common shares, which will continue to trade on the Nasdaq subject to the Company's continued compliance with the other listing requirements of the Nasdaq. The common shares of the Company will continue to trade under the symbol "INM". The Company intends to monitor the closing share price for its common shares and explore available options to regain compliance."
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KULR | Hot Stocks08:35 EDT KULR Technology, Forge Nano form strategic partnership - KULR Technology Group announced that it has entered into a Memorandum of Understanding, MoU, with Forge Nano, a global leader in precision nanocoating technology. The strategic partnership, initially estimated at a $3.5 million to $5 million revenue opportunity, will combine KULR ONE Design Solutions offerings that include cell characterization and advanced automated battery cell screening capabilities with Forge Nano's proprietary Atomic Layer Deposition coating process. This strategic partnership will start with the assessment of Forge Nano's premium battery cells for space and US Department of Defense applications employing KULR's automated cell screening to measure voltage, temperature, and impedance of individual battery cells, analyzing the data to identify potential issues and optimizing battery cell performance compliant within the strict NASA flight specification EP-WI-037 crucial for ensuring safety and reliability.
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SURG | Hot Stocks08:35 EDT SurgePays partners with ClearLine Mobile for LCD tablet interface - SurgePays entered into an exclusive partnership with ClearLine Mobile to launch a customer-facing LCD tablet interface for convenience store checkout registers. The 10-inch LCD touchscreen hardware is integrated into the SurgePays software platform and will market SurgePays products 24/7 with ads controlled from a central server. Customers can easily use the device to sign up for the Federal ACP program and conduct wireless activations or payment transactions right at the register while checking out.
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GLMD | Hot Stocks08:35 EDT Galmed granted new patent for aramchol in Japan - Galmed announced the allowance of a Japanese patent related to treatment of pulmonary and dermal fibrosis. A similar patent was already granted in Mexico. The approval of the patent in the US and the rest of the world is pending. With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until November 2037.
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GWRE | Hot Stocks08:34 EDT Guidewire selected by Vaudoise to power operating systems - The Vaudoise Insurance Group and Guidewire announced last night that Vaudoise has chosen Guidewire InsuranceSuite operating on Guidewire Cloud to power its core operating systems. Vaudoise will implement InsuranceSuite in several stages, starting with claims operations for their motor line of business. This will be followed by deployment to all P&C lines of business for claims operations and policy administration.
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PBLA | Hot Stocks08:34 EDT Panbela announces new patent in China for the production of SBP-101 - Panbela Therapeutics announced an Issue Notification for the Chinese patent 201980010826.7 titled "METHODS FOR PRODUCING -3,8,13,18- TETRAAZAICOSANE-6,15-DIOL". This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101 , a lead investigational product. The patent is valid until 2039. Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela Therapeutics, commented, "This expansion of coverage into China and Asia as a whole, is significant for our patent portfolio and aligns with our global clinical programs. With a shorter synthesis of SBP-101, there are several advantages including a more scalable, efficient, and cost-effective manufacturing process. These benefits are essential for future efforts, as they can potentially reduce production costs and improve the overall competitiveness of SBP-101 in the market. Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International Ltd., said, "We are delighted with the continued success of our longstanding collaboration with Panbela. Our partnership with them dates back to 2013 and since then we have collaborated on multiple projects. In this case, streamlining the production process of an investigational product is a core expertise in our Development Services division. A simpler production process means that commercialization will be easier, and the drug will reach patients more quickly. The protection of SBP-101 production through patents in multiple markets and now in China are significant milestones." Dr. Simpson added, "This achievement underscores the Company's commitment to protecting its intellectual property, advancing it's products on a global scale, which can potentially lead to a broader market access and increased opportunities for SBP-101's success."
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PBLA | Hot Stocks08:33 EDT Panbela Therapeutics issued new patent in China for SBP-101 production process - Panbela announced an Issue Notification for the Chinese patent 201980010826.7 titled "METHODS FOR PRODUCING-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL". This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101, a lead investigational product.The patent is valid until 2039.
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SIRI LSXMA | Hot Stocks08:33 EDT Sirius XM confirms receipt of proposal from Liberty Media - Sirius XM (SIRI) acknowledged that the special committee of independent directors of the board of SiriusXM received a non-binding proposal from Liberty Media (LSXMA) regarding a potential transaction involving the company. The potential transaction would consist of the separation of the assets and liabilities attributed to the Liberty SiriusXM tracking stock group from Liberty Media through the split-off of a newly formed company and the subsequent combination of Newco and SiriusXM, as a result of which the holders of Liberty SiriusXM tracking stock and SiriusXM common stock would all hold one class of common stock of the combined company. The Special Committee, together with its advisors, Solomon Partners Securities, LLC and Debevoise & Plimpton LLP, is evaluating the Proposal.
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YS | Hot Stocks08:33 EDT YS Biopharma enrolls first subject in Phase 3 clinical trial of rabies vaccine - YS Biopharma has enrolled the first subject in its Phase 3 clinical trial of the company's PIKA Rabies Vaccine. The PIKA Rabies Vaccine, which utilizes YS Biopharma's proprietary PIKA adjuvant technology, is designed to produce a more robust immune response in an accelerated timespan compared to existing rabies vaccines. Previous Phase 1 and Phase 2 clinical trials of the PIKA Rabies Vaccine have demonstrated its safety and immunogenicity, with the PIKA Rabies Vaccine eliciting a detectable immune response in as quick as seven days. Given these results, the PIKA Rabies Vaccine has the potential to achieve best-in-class accelerated protection and meet the WHO's goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. The Phase 3 trial's primary goal is to assess the lot-to-lot consistency, immunogenicity, and safety of the PIKA Rabies Vaccine, while also seeking to demonstrate the immunologic non-inferiority and superiority of the PIKA Rabies Vaccine compared to a control vaccine.
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IRTC | Hot Stocks08:33 EDT iRhythm launches next generation Zio monitor, enhanced Zio service - iRhythm Technologies announced the U.S. launch of its next-generation Zio monitor and enhanced Zio long-term continuous monitoring service. "We've made our best product even better - early clinical and patient experience shows that Zio monitor has even better wear times, comfort and patient experience," said Mintu Turakhia, MD, MAS, Chief Medical Officer, Chief Scientific Officer and Executive Vice President, Product Innovation at iRhythm. "When you combine our new Zio monitor with our advanced AI, efficient workflow, patient and clinician apps, and easy-to-read and actionable clinical reports, we continue to lead the way in the field."
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RIG | Hot Stocks08:32 EDT Transocean announces proposed private offering of $300M of secured notes - Transocean announcedthat Transocean Aquila, a wholly owned indirect subsidiary of Transocean Ltd., commenced a private offering of U.S. $300 million in aggregate principal amount of senior secured notes due 2028 to eligible purchasers pursuant to Rule 144A/Regulation S. The Notes will be guaranteed by Transocean Ltd., Transocean Inc., and a wholly-owned indirect subsidiary that initially will own the Deepwater Aquila and will be secured by a lien on the Deepwater Aquila and certain other assets related to the rig.
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LSPD | Hot Stocks08:32 EDT Lightspeed reappoints Brouillette to board of directors - Lightspeed Commerce announces that Manon Brouillette has been re-appointed to its Board of Directors, effective October 1, 2023. This is Manon Brouillette's second term as one of Lightspeed's Board members.
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BLNK | Hot Stocks08:30 EDT Blink Charging, Parkopedia in deal to integrate over 4,000 EV charging locations - Blink Charging announced an agreement with Parkopedia, "a leading global connected car and parking services provider, to integrate over 4,000 Blink EV charging locations onto the Parkopedia platform in North America." This strategic integration will grant the platform access to nearly 12,000 Blink public EV chargers, which includes 129 DC Fast Chargers. Parkopedia is a connected car services provider used by automakers, organizations, and millions of drivers around the world to seamlessly find the closest available parking to their destination, pay for parking, and obtain information on EV charging, fuel, and tolls across 90 countries. The agreement between Blink and Parkopedia will integrate more than 4,000 Blink's locations of nearly 12,000 publicly available Blink EV chargers into Parkopedia's network. This collaboration between the two companies will substantially improve the EV driver's ability to locate EV charging points, and directly address concerns about the availability of EV charging infrastructure. "Our collaboration with Parkopedia creates a streamlined experience for EV drivers to conveniently locate Blink EV charging stations across North America," said Jim Nemec, Chief Revenue Officer for Blink Charging. "The combination of Parkopedia's excellence in serving drivers through convenience in parking accessibility and Blink's extensive range of public EV chargers gives EV drivers confidence in finding a reliable charging experience wherever they are. This initiative builds upon our strategy of making it easy for EV drivers to locate Blink chargers through a variety of platforms." Today's announcement follows Blink's recent Q2 2023 earnings release, the strongest in Company history, which saw total revenues increase to nearly $33M for the quarter. Blink also announced it raised its 2023 revenue target from $100 - $110M to $110 - $120M and is targeting a positive adjusted EBITDA break-even run rate by December of 2024.
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UGRO | Hot Stocks08:29 EDT Urban-Gro awarded new contract worth $11M - Urban-Gro announced that the company was awarded a new contract with an existing client in the hospitality and recreation sector in the Southeast region of the United States. The contract scope includes architecture, design, engineering, and construction management services in the initial amount of more than $11M and will be predominantly realized over the next six quarters.
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OPRX | Hot Stocks08:29 EDT OptimizeRx announces new AI solution for HCP engagement platform - OptimizeRx announced a new artificial intelligence solution, transforming its HCP engagement platform. The new capability expands the Company's patent-pending HCP engagement technology to include social, web-display channels, and CRM alerts, which create more efficiencies directly with sales forces. With this development, the Company has renamed its HCP engagement platform the Dynamic Audience Activation Platform, to mark the unification of its former RWD-AI capability with its full omni-channel network and new proprietary physician engagement dataset. The new DAAP advances the Company's land-and-expand strategy by enabling its clients to gain maximum market penetration by scaling their outreach in real-time across the Company's network of over 2 million HCPs across multiple major digital media channels, and at point-of-care via electronic health records, e-Prescribing, and telehealth platforms.
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BLNK | Hot Stocks08:29 EDT Blink Charging announces agreement with Parkopedia - Blink Charging announced an agreement with Parkopedia, a leading global connected car and parking services provider, to integrate over 4,000 Blink EV charging locations onto the Parkopedia platform in North America. This strategic integration will grant the platform access to nearly 12,000 Blink public EV chargers, which includes 129 DC Fast Chargers. "Our collaboration with Parkopedia creates a streamlined experience for EV drivers to conveniently locate Blink EV charging stations across North America," said Jim Nemec, Chief Revenue Officer for Blink Charging. "The combination of Parkopedia's excellence in serving drivers through convenience in parking accessibility and Blink's extensive range of public EV chargers gives EV drivers confidence in finding a reliable charging experience wherever they are. This initiative builds upon our strategy of making it easy for EV drivers to locate Blink chargers through a variety of platforms."
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MDGL | Hot Stocks08:29 EDT Madrigal Pharmaceuticals Chief Commercial Officer leaving company - In a regulatory filing last night, Madrigal Pharmaceuticals reported that Remy Sukhija, who has served as the company's Chief Commercial Officer since April of 2020, is leaving the company to pursue other opportunities.
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BMRA | Hot Stocks08:28 EDT Biomerica announces Dubai gov approved insurance reimbursement for EZ Detect - Biomerica announced that the Dubai government, gov, has officially approved insurance reimbursement for the EZ Detect colorectal disease at-home screening test, which is designed to detect an early warning sign of colorectal cancer and other colorectal diseases. Colorectal cancer is the second most common cause of cancer death in the UAE.
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LCFY TRU | Hot Stocks08:27 EDT Locafy, TransUnion partner to add 17M listings to global publishing network - Locafy announced a strategic commercial partnership with TransUnion to publish over 17 million business listings in Hotfrog.com, a top-20 free online directory which Locafy acquired in 2016. Through its TruContact Digital Search Business Listings, powered by Neustar solution, the collaboration will assist in increasing Locafy's existing publishing network by 34% to approximately 66 million pages. TransUnion will also work closely with Locafy to help ensure that data is up-to-date on the Hotfrog network via API connectivity and is exploring opportunities to collaborate on new product releases with the Company.
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BB | Hot Stocks08:27 EDT BlackBerry seleted by Mitsubishi for in-vehicle system - BlackBerry announced that Mitsubishi Electric's new automotive in-cabin system, Mitsubishi Electric FLEXConnect, will be powered by BlackBerry IVY, an edge-to-cloud vehicle data platform. BlackBerry IVY allows the platform to extract and analyze data from internal and external sensors and leverages machine learning to process all data collected at the vehicle edge compute node.
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SLNO | Hot Stocks08:27 EDT Soleno Therapeutics up 190% in pre-market after DCCR study data - Shares of Soleno Therapeutics are up 190% or $8.75 in pre-market trading at $13.53 after the company disclosed positive top-line results from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR Extended-Release tablets for the treatment of Prader-Willi syndrome.
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MOTS | Hot Stocks08:26 EDT Motus GI Holdings submits special 510k to FDA for Pure-Vu EVS - Motus GI Holdings announced that it has submitted a special 510(k) to the U.S. Food and Drug Administration for market clearance of its Pure-Vu Gen 4 Gastro and Colon. A special 510(k), according to FDA guidance, has an initial review usually within 30 days of receipt. The Pure-Vu EVS Gen 4 Gastro for upper gastrointestinal procedures and the improved version for the colon each provide significant benefits compared to previous Pure-Vu models and are designed to potentially open new segments of the GI market by introducing new capabilities while also addressing factors that make it easier to work with commercial partners. "The submission of this special 510(k) to the FDA brings us one step closer to being able to commercially launch our next generation system in the U.S. market. Expanding the Pure-Vu platform's capabilities into supporting upper GI procedures, an area of high unmet patient need, should accelerate the adoption of the Pure-Vu system in the market," commented Mark Pomeranz, Chief Executive Officer. "Our submission for 510(k) clearance of the Pure-Vu Gen 4 Gastro and Colon is supported by positive preclinical and clinical data collected by some of the top key opinion leaders in both the U.S. and abroad. These data show the value our new platform offers hospitals and patients suffering from a number of indications."
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RDVT | Hot Stocks08:25 EDT FOREWARN partners with Florida REALTORS - FOREWARN announced that Florida Realtors has contracted to make FOREWARN services available for the 238,000 members they serve throughout the State of Florida to promote proactive real estate agent safety.
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DKS | Hot Stocks08:25 EDT Dick's Sporting to hire 8,600 seasonal teammates for holidays - Dick's Sporting Goods plans to hire 8,600 seasonal teammates for the 2023 holiday season. The sixth-annual "National Signing Day" on October 3 will kick off holiday recruiting efforts for positions at Dick's Sporting Goods, Public Lands, Dick's House of Sport, and Going, Going, Gone! stores across the country.
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INFN SMFG | Hot Stocks08:25 EDT Infinera, Sumitomo Mitsui announce completion of first demonstration - Infinera (INFN) and Sumitomo Electric Industries (SMFG) announced the successful completion of the first demonstration delivering high-speed business services over Sumitomo Electric's passive optical network infrastructure with Infinera's ICE-X intelligent coherent pluggable optics. The demonstration validated how Sumitomo Electric can leverage next-generation coherent pluggables to provide improvements to network efficiencies and expand capacity, while also enabling new high-speed business services and supporting next-generation applications such as 5G and edge computing. The demonstration leveraged Infinera's suite of intelligent coherent pluggable optics compliant with specifications set forth by the Open XR Forum, a multi-source agreement working group for XR optics, the industry's first point-to-multipoint coherent pluggable transceiver technology. Sumitomo Electric, a member of the Open XR Forum, conducted the test in its Osaka Works facility using its FSU 7100 10G-EPON OLT product with Infinera's ICE-X 100G and 400G coherent pluggable transceivers hosted in Sumitomo Electric's FTU 9100 metro/access aggregation switch.
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APO | Hot Stocks08:24 EDT Apollo Global marks one-year anniversary of Apollo Academy - Apollo marked the one-year anniversary of the launch of Apollo Academy, a knowledge center designed specifically for the financial-professional community. Launched in September 2022, Apollo Academy delivers a product-agnostic education ecosystem for advisors and intermediaries to learn about the role alternatives can play in individuals' portfolios and is an integral resource supporting the growth of Apollo's Global Wealth business. The Academy offers a full suite of learning modules on investing in alternatives, complete with continuing-education accreditation through live and on-demand events. It also features current investment intelligence from key experts at the firm, delivering markets and industry insights through white papers, articles, podcasts, the Daily Spark blog and more. Driven by the democratization of private market investments, the Academy exemplifies Apollo's efforts to create a purpose-built global wealth platform with resources to help investors and retirees learn about the potential benefits of alternatives in individuals' portfolios.
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GALT | Hot Stocks08:23 EDT Galectin Therapeutics to present update on belapectin liver cirrhosis program - Galectin Therapeutics will participate in the 20th edition of the Discovery on Target meeting, the industry's preeminent event on Novel Drug Targets and Technologies. The Company will present an update on its belapectin liver cirrhosis program during the Fibrosis and Inflammation session. The presentation, titled "Targeting Activated Macrophages to Improve Liver Cirrhosis: The Discovery and Clinical Translation of Belapectin," will take place Wednesday, September 27, at 2:25 PM EDT and will be delivered by Dr. Pol F. Boudes, M.D., Chief Medical Officer of Galectin Therapeutics. Boudes commented: "The role of activated macrophages in the establishment and progression of liver cirrhosis is predominant. These cells, when activated, invade the liver, and produce galectin-3, a pro-inflammatory and pro-fibrotic molecule. Belapectin is a galectin-3 inhibitor that, thanks to its unique molecular structure, is captured by activated macrophages and can inhibit galectin-3 at its site of production. Liver cirrhosis has been a field that has been neglected for far too long by drug developers and the Discovery on Target meeting is an excellent opportunity to familiarize a large audience to the consequences of liver cirrhosis and portal hypertension and highlight the opportunity our belapectin program offers for patients affected by this severe disease."
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BBLG | Hot Stocks08:23 EDT Bone Biologics provides scientific update on NB1 bone graft device - Bone Biologics provides an update on its clinical development initiatives with its NB1 bone graft device. NB1 consists of the recombinant human protein NELL-1 combined with demineralized bone matrix . The 30-patient pilot study is expected to be conducted in Australia. Earlier this year, the Human Research Ethics Committee approved Monash Health as the first site. "We are encouraged by the ongoing progress in preparing to advance NB1 into human testing and look forward to the start of our pilot study before the end of the year," said Jeffrey Frelick, president and chief executive officer of Bone Biologics. The company has completed the following preparatory activities: Assay Qualification and Validation All analytical assays required for the drug substance and the drug product have been successfully validated. Similar recombinant human NELL-1 or rhNELL-1, drug substance attributes were demonstrated between different rhNELL-1 lots and the cGMP drug substance lot. The in vitro cell-based attachment potency assay has been successfully qualified. Similar relative potency was demonstrated between different rhNELL-1 lots and the cGMP drug substance lot has passed the potency specification. In vivo potency testing demonstrated osteopromotion activity for the cGMP rhNELL-1 drug substance. The engineering and the cGMP drug substance lots have passed all required specifications. Medical Device Biocompatibility Testing The ISO 10993 GLP biocompatibility testing has been completed. NB1 showed no evidence of causing cell lysis or toxicity, no sensitization and was not mutagenic or pyrogenic. The clinical observations, body weights, necropsy observations, organ weights, organ/body weight ratios and organ/brain weight ratios were not adversely affected.
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RUN | Hot Stocks08:23 EDT Sunrun appoints Mueller as VP of Generation, Srivastava as Head of AI - Sunrun has appointed Dr. Marcus Mueller as Vice President, VP, of Generation and Rachit Srivastava as Head of Artificial Intelligence, AI. Mueller joins Sunrun after serving as Senior Manager of Energy Operations and Head of Government Relations, Europe, at Tesla Energy for six years. Srivastava joins Sunrun after nearly three years as Head of Machine Learning at Cockroach Labs.
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HSCS | Hot Stocks08:21 EDT Heart Test Laboratories receives two new patent allowances - Heart Test Laboratories announced that it has been issued a notice of patent allowance from the Brazilian Patent and Trademark Office and the United Arab Emirates, UAE, Ministry of Economy, Intellectual Property Protection Department. These new patent awards increase HeartSciences' patent portfolio to now include 33 international granted or allowed patents and 9 US granted patents covering well over 100 claims. Andrew Simpson, Chief Executive Officer of HeartSciences, commented, "AI is now in daily use in healthcare and is expected to reinvent the ability of an ECG to screen for heart disease. We are pleased to further strengthen our extensive intellectual property portfolio as AI is expected to drive significant growth in the ECG market to $25 billion per year by 20321. HeartSciences is a leader in AI-based ECG technology being used in everyday clinical practice, and with the recent signing of agreements with Mount Sinai, a top-ranked hospital in cardiology, we expect to significantly expand our ECG cardiovascular disease screening capabilities."
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GENI CZR | Hot Stocks08:20 EDT Genius Sports unveils BetVision - Genius Sports (GENI) has unveiled BetVision. Genius Sports is launching BetVision with NFL live games in the U.S. BetVision will allow sportsbook customers to place wagers from within the live video player in the sportsbook app. These low latency live game video streams feature integrated betting odds and betslips and will be enhanced by in-game betting alerts and on-screen offers during breaks in game action to increase relevance, drive engagement and retain customers. NFL content is available on mobile and tablet devices and will include live augmentations such as data-driven insights, graphic overlays and visualizations already in use with a range of broadcast and streaming partners across North America. BetVision is a uniquely personalized product that allows users to toggle on and off content and stats to create a tailored viewing experience based on their individual preferences. In the initial launch, U.S. sports betting operators Caesars Sportsbook (CZR) and Fanatics Sportsbook are the first to be live with the product. Each operator will stream nationally distributed and local, regionalized live NFL games each week. Over the course of the 2023 NFL season, additional features and functionality will be added.
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CADL | Hot Stocks08:20 EDT Candel Therapeutics reports initial survival data from Phase 2 trial of CAN-2409 - Candel Therapeutics announced updated activity data from its ongoing, open-label, phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor reatment in patients with non-resectable, stage III/IV non-small cell lung cancer, who have an inadequate response to front line anti-PD(L)1 therapy. These patients historically have had an expected median overall survival of 10-13 months. The aim of the CAN-2409 immunotherapy antitumor strategy is to raise the tail on the survival curve by increasing the number of long survivors beyond 10-13 months. In 2022, the Company presented data from this phase 2 clinical trial where patients who received two administrations of CAN-2409 plus prodrug demonstrated increased infiltration of CD8+ cytotoxic T cells in the tumor microenvironment, systemic expansion of effector T cells and increased soluble granzyme B levels in peripheral blood, favorable changes in the trajectory of tumor progression, decreased tumor size of target lesions in most patients, and reduced size of uninjected tumor lesions. These data were further confirmed in the current update. Highlights as of August 1, 2023 data cutoff, include: As of data cutoff, 40 patients across Cohort 1 and Cohort 2 were evaluable, as they received two courses of CAN-2409 + valacyclovir and completed the 12-week treatment window. While overall survival is not yet mature, Candel has observed an encouraging number of long survivors, which the Company believes that CAN-2409 may induce a new state of functional immunosurveillance and durable disease control in a subset of the patients. Of the 40 evaluable patients, 15 patients have lived greater than or equal to 12 months; of these, 10 patients have lived greater than 18 months, of whom 70% were alive as of last follow up. All 4 patients with OS greater than 24 months were alive at last follow up, with the longest reaching 31.7 months. An additional 18 out of the 40 evaluable patients are also alive but have not yet reached 12 months of follow up. Notably, many patients treated with CAN-2409 have had long survival despite having disease features generally associated with advanced disease and reduced likelihood to benefit from ICI therapy, such as low or negative PD-L1 expression, including: Amongst patients alive greater than or equal to 12 months with known PD-L1 status, 93% had negative or low PD-L1 score. Advanced disease with stage IV in 73%, lymph node involvement in 73%, pleural effusion in 40%, bone metastases in 27%, adrenal metastases in 20%, brain metastases in 13%, liver metastases in 7%, involvement of 3 or more organs in 13%, and ECOG performance status 1 in 40%. There was a significant increase observed in activated central memory, effector-memory, effector T cells, and NK cells after CAN-2409 treatment. These include CD8+Ki67+IFNg+ T cells, CD8+ granzyme B+Ki67+ T cells, CD56+CD16+granzyme B+ NK cells, and gd+ T cells. Candel also observed an increase in B memory cells after CAN-2409 treatment. Candel observed an increase in effector/cytotoxic T cells and NK cells in peripheral blood after the second CAN-2409 administration associated with improved survival. Candel continued to observe a favorable safety / tolerability profile after CAN-2409 treatment in NSCLC. There were no dose limiting toxicities or grade 4 or greater treatment related adverse events. Grade 3 treatment related adverse events were reported in less than 10% of patients receiving at least one dose of CAN-2409, which Candel believes compares favorably to current standard of care options. Candel expects to share topline overall survival data for Cohort 2 in the second quarter of 2024, assuming mature data at that time.
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UPS | Hot Stocks08:20 EDT UPS recruits 100,000 seasonal workers for The 2023 Holiday Season - UPS announced it will hire more than 100,000 seasonal employees to serve the 2023 holiday rush. As the industry leader in on-time delivery performance for five consecutive peak seasons, UPS is positioned again to deliver the reliable service that customers depend on year-round, especially during the important holiday shopping season. The company is filling full- and part-time seasonal positions - primarily seasonal delivery drivers, Commercial Driver's License drivers and package handlers - by offering competitive wages and multiple shifts in hundreds of locations across the country. Permanent positions also are available in some areas for those who apply early. The company's streamlined, digital application process now takes less than 20 minutes for most people - from filling out an online application to receiving a job offer. And nearly 80% of seasonal positions do not require an interview. "The best talent delivers the best service. That's why we're proud to offer industry-leading pay for UPS part-timers, full-timers and seasonal employees alike," said Nando Cesarone, Executive Vice President and President, U.S. "We're looking forward to delivering yet another leading on-time performance this holiday season and helping thousands of workers kick off their UPS careers in the process."
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BFRG | Hot Stocks08:19 EDT Bullfrog AI announces data from preclinical study on BF-222 - BullFrog AI announced positive data in a preclinical study investigating the anti-cancer activity of a novel prodrug of mebendazole for the treatment of glioblastoma. The study assessed the relative efficacy of BF-222, a novel formulation of mebendazole that has been evaluated in clinical trials, and BF-223, a novel prodrug of mebendazole with improved solubility and bioavailability relative to BF-222, compared with placebo in mice that had been implanted with tumor cells as a model for human glioblastoma. Animals treated with BF-223 had an average survival time of 27.9 days compared with 27.3 days for mice treated with BF-222 and 23.4 days for mice given placebo. Mice treated with BF-223 were administered 80% of the dose that mice treated with BF-222 received, and improved outcomes for both treatment groups were statistically significant compared to placebo. In addition, animals treated with equivalent doses of BF-222 and BF-223 showed comparable and significant reduction in tumor growth compared to control animals during the study. Vin Singh, Chairman and CEO of BullFrog AI, said, "The data from this study, combined with BF-223's improved properties, gives us confidence that BF-223 has potential to be an effective treatment in the fight against glioblastoma, a form of cancer for which there are few good treatment options. We are currently pursuing partnering opportunities for BF-222 and BF-223 with pharmaceutical companies and are confident that these data will assist in that effort."
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HROW CTLT | Hot Stocks08:18 EDT Melt announces exclusive development and license pact with Catalent for Zydis - Melt Pharmaceuticals, "a clinical-stage pharmaceutical company developing novel approaches for procedural sedation," and a former subsidiary of Harrow Health (HROW) announced it recently entered into an exclusive development and license agreement with Catalent, Under the terms of the agreement, Melt Pharmaceuticals will utilize Catalent's proprietary Zydis orally disintegrating tablet ODT ast-dissolve technology with MELT-300, a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery in the U.S. and any other countries mutually agreed upon by both parties. MELT-300, which combines fixed doses of midazolam and ketamine is administered sublingually for procedural sedation during cataract surgery and utilizes Zydis ODT technology to rapidly dissolve the tablet for absorption across the very thin sublingual mucosa. Catalent's Zydis ODT technology is currently used in over 35 FDA-approved and U.S.-marketed products. "This exclusive license with Catalent is a key milestone for the continued development of MELT-300," said Larry Dillaha, M.D., CEO of Melt Pharmaceuticals. "We chose Catalent's Zydis delivery technology because it is a proven fast-dissolving technology, and with the Zydis technology, our product candidate dissolves in a matter of seconds and begins to be absorbed across the sublingual mucosa. We believe this technology could eliminate the need for painful needle sticks in many procedures in the future." Dillaha continued, "We look forward to continuing to build our partnership with Catalent on MELT-300 through this exclusive license, which fortifies an already strong domestic and international patent portfolio. This agreement allows us, going forward, to develop, consistent with our vision, procedural sedation solutions for the approximately 100+ million annual procedures our technology may impact." Melt Pharmaceuticals previously announced that MELT-300 achieved the procedural sedation primary endpoint in its Phase 2 efficacy and safety study. Melt Pharmaceuticals is currently in discussions with the FDA on the Phase 3 program, which Melt expects to begin in early 2024.
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VCNX | Hot Stocks08:18 EDT Vaccinex reports findings at medical conferences on Pepinemab - Vaccinex will report on novel findings for its lead product, pepinemab, with implications for treatment of Alzheimer's and other slowly progressive neurodegenerative diseases and for cancer immunotherapy at two upcoming Medical Conferences. Results from phase 2 SIGNAL trial suggest pepinemab is the first therapeutic agent that appears to have the potential to prevent decline in brain metabolic activity and to slow or halt cognitive decline in Huntington's disease. Encouraged by these findings, a separate, randomized, phase 1/2a study in AD is ongoing in which the last patient is anticipated to complete the planned 12-months of treatment in early June 2024. Pepinemab in combination with a checkpoint inhibitor is, the first treatment that has shown the potential to induce formation of lymphoid structures in tumors that promote efficient immune responses and are known to be associated with improved outcomes in head and neck cancer. Clinical results indicate an approximate doubling of objective responses and progression free survival relative to historical results with checkpoint monotherapy in patients with hard-to-treat tumors that express low levels of PD-L1. Alzheimer's Disease: Vaccinex completed enrollment in the randomized, double-blind SIGNAL-AD phase 1/2a study for early AD in May 2023. The last patient is anticipated to complete the planned 12 months of treatment by early June 2024 at which time the database will be locked and results analyzed. Key endpoints include brain metabolic activity along with measures of cognition specific to AD. Clinical consensus is that Leqembi and donanemab provide a modest but real benefit to patients at a very early stage of disease. Common side effects associated with these drugs, however, include an inflammatory and hemorrhagic response in brain denoted as ARIA. "We believe that use of pepinemab to treat slowly progressive neurodegenerative diseases like AD has been substantially de-risked by results from our completed phase 2 study in HD,: the company said. Cancer: The Phase 2 KEYNOTE-B84 study evaluated Vaccinex's pepinemab antibody in combination with Merck's anti-PD-1 therapy, KEYTRUDA for immunotherapy of recurrent or metastatic head and neck squamous cell carcinoma. Results of a preplanned interim analysis of the first 36 patients treated in this study indicated that the Objective Response for the PD-L1 low population, CPS less than20, was 21.1% and median progression free survival was 5.79 months, which are approximately twice that of historical ORR and PFS for checkpoint monotherapy in this population. In contrast, in the CPS greater than or equal to20 subgroup, the ORR and PFS for combination therapy was similar to historical checkpoint monotherapy. The results indicate that treatment with pepinemab in combination with KEYTRUDA appears to induce formation of highly organized lymphoid aggregates in the tumor of patients who demonstrate disease control.
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UNFI | Hot Stocks08:16 EDT United Natural Foods down 19% after below-consensus FY24 guidance - Shares of United Natural Foods are down 19% or $3.54 at $15.38 after the company reported Q4 results and issued initial FY24 guidance below consensus estimates.
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EWTX | Hot Stocks08:15 EDT Edgewise Therapeutics initiates enrollment of GRAND CANYON study - Edgewise Therapeutics announced the start of enrollment of GRAND CANYON, a global pivotal study of EDG-5506 in individuals with Becker. GRAND CANYON is an expansion of the CANYON study. CANYON, which was over-enrolled, includes 39 adults and 24 adolescents. EDG-5506 is an orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies including Becker and Duchenne muscular dystrophy. There are currently no approved therapies for individuals with Becker, a serious genetic, progressive neuromuscular disorder with significant unmet need.
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BIVI | Hot Stocks08:14 EDT BioVie completes last patient treatment visit in Phase 3 trial of NE3107 - BioVie announced that the last patient has completed the last visit at week 30 in its multicenter, randomized, placebo-controlled Phase 3 study of NE3107 in patients with mild to moderate Alzheimer's Disease. The Company's clinical monitors have started the process working with each clinical site to ensure that the electronic data capture database properly reflects the assessments captured during the various clinical visits. This is the critical first step to creating and locking the database for analyzing the trial results and the eventual submission to the FDA for their review. The trial's Statistical Analysis Plan that pre-specifies the analyses and treatment populations and subgroups will be submitted to the FDA prior to locking the EDC.
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BAH | Hot Stocks08:14 EDT Booz Allen announces investment in HiddenLayer, terms undisclosed - Booz Allen announced that its corporate venture capital arm, Booz Allen Ventures, has made a strategic investment in HiddenLayer, a security platform that safeguards machine learning, or ML, models. This investment strengthens and expands Booz Allen's tenured Adversarial AI capabilities, including those developed for the Department of Defense and intelligence clients, and will further accelerate secure adoption of enterprise AI solutions to keep pace with emerging national security threats as well as rising consumer expectations.
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CUE | Hot Stocks08:13 EDT Cue Biopharma completes patient enrollment in Phase 1b study of CUE-101 - Cue Biopharma announced that it has completed patient enrollment in its Phase 1 clinical trial evaluating CUE-101, the company's lead interleukin 2-based biologic from the CUE-100 series, in combination with KEYTRUDA as first-line treatment for patients with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma. "Completing the enrollment of the recommended phase 2 dose patient expansion cohort is an important milestone as the data from this trial guides further development plans and associated discussions with the Food and Drug Administration," said Daniel Passeri, chief executive officer of Cue Biopharma. "We believe the updated data will build upon the already promising clinical profile established to date, which has shown an enhancement of clinical efficacy with the CUE-101-pembrolizumab combination compared to pembrolizumab alone. With the strength of the data already observed with monotherapy in second line patients and beyond, combined with the promising combination data emerging in 1L with pembrolizumab, we plan to discuss potential registrational paths with the Food and Drug Administration for CUE-101 both as a monotherapy and in combination with pembrolizumab, leveraging the Fast Track Designation previously granted to these programs."
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OB | Hot Stocks08:12 EDT Outbrain, DoubleVerify partner to enhance Onyx campaigns - Outbrain announced a strategic partnership to bring DV Marketplace Suite's comprehensive pre-bid brand suitability, fraud avoidance, and viewability tools to Outbrain's recently-launched branding platform, Onyx. "This partnership further demonstrates our commitment to delivering an exceptional advertising experience where advertisers can feel confident their Onyx campaigns only run in brand-suitable environments with verified and certified results by a globally-recognized third-party," said Ayal Steiner, EVP of Brand Solutions, Outbrain. "Our goal is to simplify the advertiser experience and deliver a seamless, turnkey solution, and this partnership is an important milestone in this direction."
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SRTS | Hot Stocks08:12 EDT Sensus Healthcare to showcase full line of superficial radiotherapy devices - Sensus Healthcare announces its participation in the American Society for Radiation Oncology Annual Meeting to be held in San Diego from October 1-4. Leveraging this esteemed event, Sensus Healthcare is set to present its full line of state-of-the-art superficial radiotherapy devices for the treatment of non-melanoma skin cancer and keloids to hospital administrators and radiation oncologists from around the world. ASTRO is the premier gathering of radiation oncology professionals, where industry leaders converge to discuss breakthrough technologies and cutting-edge treatment methodologies. As a pioneer in the field of non-invasive, non-pharmaceutical oncology treatment, Sensus Healthcare is excited to showcase its advancements in superficial radiotherapy at this prestigious event, while demonstrating its SRT-100, SRT-100+, SRT-100 Vision with IG-SRT, using the latest ultrasound technology for accurate visualization of the dermis and Sentinel, its proprietary IT Solutions product. Sensus Healthcare's devices utilize the Multi-Dimensional Superficial Radiotherapy platform, which provides an alternative low-energy X-ray treatment for various types of non-melanoma skin cancer and keloids. Designed to deliver effective and safe radiotherapy, SRT offers patients a non-surgical, painless and cosmetically appealing treatment option. By enabling seamless integration with existing healthcare systems, Sensus Healthcare's solutions ensure enhanced flexibility and convenience for healthcare providers. With the goal of improving patient quality of life, Sensus Healthcare prides itself on offering innovative, patient-centric solutions. ASTRO 2023 provides an exceptional opportunity for attendees to explore the capabilities of Sensus' advanced technologies and engage with company representatives. Participants will gain valuable insights into Sensus' unparalleled product portfolio, which boast minimal side effects and industry-leading clinical outcomes.
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SRFM TXT | Hot Stocks08:12 EDT Surf Air Mobility confirms aircraft order & Textron deal for electric Cessna - Surf Air Mobility (SRFM) or SAM, "a regional air mobility platform aiming to sustainably connect the world's communities," confirmed its exclusive relationship with Textron Aviation (TXT) , upon the completion of its public market debut...the company announced that deliveries of the first 20 Cessna Grand Caravan EX aircraft are expected to begin in the first half of 2024. This exclusive relationship supports Surf Air Mobility's development of an electrified Cessna Grand Caravan EX, targeting FAA certification in 2026. Surf Air Mobility has agreed to purchase up to 150 Cessna Grand Caravan EX aircraft, with a confirmed initial fleet order of 100 aircraft and an option for 50 more. The aircraft will be upgraded to Surf Air Mobility's proprietary electric or hybrid-electric powertrain technology by Surf Air Mobility. Through this exclusive agreement, Surf Air Mobility plans to make electrified aircraft broadly available to new and existing operators, and to bring the benefits of lower cost, lower emission air travel at scale to customers. Surf Air Mobility will also be the exclusive provider to Textron Aviation of certain battery electric and hybrid electric powertrain technology for the Cessna Grand Caravan... "We are very proud of our relationship with Textron Aviation and excited to expand our growing network with this fleet order," said Jamie Strecker, head of Business Development for Surf Air Mobility. "This order brings us closer to our ultimate goal to electrify our entire fleet and bring the world a more sustainable way to fly." The aircraft should be immediately operable at more than 5,000 public use airports across the U.S. with no charging stations required for the hybrid-electric powertrain iterations ...Reducing the environmental impact of flying and paving the way for future generations of even more sustainable aircraft ..Opening the ability for more Cessna Grand Caravan owners and operators to upgrade to the electric or hybrid powertrains..
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ZIMV | Hot Stocks08:11 EDT ZimVie announces FDA approval to launch Mobi-C Hybrid study - ZimVie announced that on September 7, 2023, the U.S. Food and Drug Administration approved its Mobi-C Cervical Disc Hybrid Investigational Device Exemption, IDE, application. The decision authorizes ZimVie to begin enrolling U.S. patients in the study, which will follow patients who receive simultaneous cervical disc arthroplasty, CDA, and anterior cervical discectomy and fusion, ACDF, at adjacent levels between C3 and C7. In some cases, the best two-level treatment may be just such a hybrid construct, where the disc replacement and fusion can be completed in one surgery, providing a clinical benefit to the patient and surgeon as well as an economic benefit to stakeholders in the healthcare delivery system. Surgeons have implanted over 200,000 Mobi-C implants for cervical disc replacement at one level or two contiguous levels since 2004. In 2013, Mobi-C became the first cervical disc approved for one and two levels by the FDA and remains the market-leading device for cervical disc replacement
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QUIK | Hot Stocks08:11 EDT QuickLogic awarded new eFPGA contract - QuickLogic has been selected by a technology company for an eFPGA IP targeting the GlobalFoundries 22FDX platform. The name of the customer cannot be disclosed at this time. QuickLogic's eFPGA solution, powered by the Australis IP generator, has been specifically chosen by the customer for its ability to create a customized version of its eFPGA IP within one quarter from contract signing.
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TSHA | Hot Stocks08:10 EDT Taysha Gene Therapies announces second patient dosed with TSHA-102 - Taysha Gene Therapies announced that the second Rett syndrome patient has been dosed with TSHA-102 in the REVEAL Phase 1/2 adult trial in Canada. TSHA-102 is being evaluated in the REVEAL Phase 1/2 adult trial in Canada, a first-in-human, open-label, randomized, dose-escalation and dose-expansion study evaluating the safety and preliminary efficacy of TSHA-102 in adult females with Rett syndrome due to MECP2 loss-of-function mutation. TSHA-102 is administered as a single lumbar intrathecal injection. Dose escalation will evaluate two dose levels of TSHA-102 sequentially. The maximum tolerated dose or maximum administered dose established will then be administered during dose expansion. Enrollment in the low-dose cohort is expected to be complete in the fourth quarter of 2023 with the dosing of the third patient. The REVEAL adult trial is being conducted at CHU Sainte-Justine, the Universite de Montreal mother and child university hospital centre in Montreal, Canada, under Principal Investigator Dr. Elsa Rossignol, M.D., FRCP, FAAP, Associate Professor Neuroscience and Pediatrics at CHU Sainte-Justine,
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PHAT | Hot Stocks08:10 EDT Phathom announces vonoprazan NDA submission for non-erosive GERD - Phathom Pharmaceuticals announced the submission of an NDA to the FDA for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease, GERD, in adults. The regulatory submission is supported by the positive data from the PHALCON-NERD-301 study, a Phase 3 study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults with Non-Erosive GERD, NERD. Vonoprazan is an investigational first-in-class potassium-competitive acid blocker from a novel class of medicines that block acid secretion in the stomach. The effectiveness and safety of vonoprazan 10 mg and 20 mg given once daily in NERD was evaluated in a randomized, placebo-controlled, double-blind, 4-week trial with a 20-week blinded extension conducted in the United States in 772 adult patients. As previously reported, both vonoprazan doses met the primary endpoint for the mean percentage of heartburn free days over the 4-week placebo-controlled period at 45%, 44%, and 28% for vonoprazan 10 mg, vonoprazan 20 mg and placebo, respectively . As previously reported, the overall adverse events were comparable between vonoprazan and placebo during the 4-week placebo-controlled period of which the most common events were nausea, abdominal pain, constipation, and diarrhea, reported at or below 3% for either vonoprazan 10 mg or 20 mg doses. The most common adverse events reported for the two vonoprazan doses during the 20-week extension period were upper respiratory tract infection, sinusitis, influenza, urinary tract infection, nasopharyngitis, nausea, and gastroenteritis, reported at or below 5%. Phathom expects a 10-month regulatory review and if approved, anticipates a third quarter 2024 U.S. launch for vonoprazan as a daily treatment for Non-Erosive GERD. Phathom also plans to initiate an additional Phase 3 study to evaluate vonoprazan as an As Needed treatment for episodic heartburn relief in adults with Non-Erosive GERD, a novel dosing treatment regimen.
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GWAV | Hot Stocks08:09 EDT Greenwave Technology's shear baler fully operational at Cleveland facility - Greenwave Technology's recently installed shear baler is now fully operational at its Cleveland, Ohio facility. The equipment is expected to significantly expand the facility's metal recycling production capacity, enabling it to significantly increase its revenues. Shear balers are highly sophisticated processing equipment within the industry, designed for efficiently shearing car bodies and heavy metals.
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GFS | Hot Stocks08:07 EDT GlobalFoundries announces annual Technology Summit in Europe - At its annual Technology Summit in Europe beginning September 27th, GlobalFoundries is highlighting key advancements to its technology platforms and solutions that will enable better power efficiency, enhanced performance and security for applications across critical end markets including IoT, smart mobile and automotive. These milestones highlight GF's semiconductor manufacturing leadership in product development, validation and market readiness for critical applications in IoT, 5G and 6G smartphones, and electric vehicles. Building upon the GF Technology Summit in North America this past August, the sessions in Munich will focus on leading at the edge, manufacturing semiconductors in a digital, AI-driven, world through the evolving landscape of communications infrastructure and the electrification of vehicles. GF's President and CEO, Dr. Thomas Caulfield, will kick-off the event with a keynote address entitled "Essential chips fuel the era of AI," which emphasizes the transformative potential of these technologies and their significance in the rapidly evolving semiconductor landscape. In addition, Peter Schiefer, Infineon Division President Automotive, Jean-Marc Chery, President and CEO of STMicroelectronics and Karsten Schnake, Board Member for Procurement at of KODA AUTO & Head of Project COMPASS at Volkswagen AG will take the stage.
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LMNL | Hot Stocks08:07 EDT Liminal BioSciences completes plan of arrangement with Structured Alpha - Liminal BioSciences is pleased to announce that the transaction contemplated by the previously announced statutory plan of arrangement under the provisions of the Canada Business Corporations Act involving the Corporation and Structured Alpha LP, a limited partnership managed by its general partner, Thomvest Asset Management Ltd., was completed on September 26. Pursuant to the Arrangement, SALP acquired all of the issued and outstanding common shares of Liminal BioSciences not currently owned by SALP or its affiliates and associates at a price of $8.50 per Share, payable in cash. As a result of the Arrangement, the Shares will no longer be listed on the Nasdaq Capital Market. In addition, the company will submit an application to cease to be a reporting issuer under applicable Canadian securities law, will file a certification and notice on Form 15 with the U.S. SEC to suspend its reporting obligations under U.S. securities laws and will otherwise terminate the company's public reporting requirements.
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AKBA | Hot Stocks08:07 EDT Akebia lowers 2023 Auryxia net product revenue guidance - Akebia slightly lowered Auryxia net product revenue guidance to $170M-$175M for 2023 from $175M-$180M due to an unfavorable impact from market dynamics, volume and payor mix.
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MDXG | Hot Stocks08:06 EDT MiMedx announces launch of EPIEFFECT - MiMedx Group announced the launch of EPIEFFECT, the Company's latest addition to its portfolio of AWC solutions. EPIEFFECT expands the Company's core AWC offering for clinicians treating acute and chronic, hard-to-heal wounds such as diabetic foot ulcers and venous leg ulcers, among other common conditions. EPIEFFECT offers a thick, tri-layer configuration that is suitable for securing the graft in place with sutures. In addition, its product attributes and handling characteristics make it a preferable treatment option for deep or tunneling wounds.
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AKBA | Hot Stocks08:06 EDT Akebia's Vafseo approved for anemia in Australia - Akebia announced that Australia's Therapeutic Goods Administration has granted approval for Vafseo, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia associated with chronic kidney disease in adults on chronic maintenance dialysis. Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin between baseline and the primary evaluation period and secondary evaluation period. Vadadustat also achieved the primary safety endpoint of the INNO2VATE program. To support the global launch of Vafseo and prepare for a potential launch in the U.S., Akebia also announced an addition to its commercial team. Akebia appointed Graham Ray as VP, Key Accounts, reporting to Bennett Smith, Senior VP, Commercial, to lead customer engagement. Ray spent over nearly 20 years at Takeda Pharmaceuticals.
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AMC | Hot Stocks08:06 EDT AMC Entertainment to bring "Taylor Swift The Eras Tour" to over 100 countries - AMC Theatres announced that "Taylor Swift The Eras Tour" concert film is going global. On October 13, "Taylor Swift The Eras Tour" concert film will play on big screens and with their big sound, expected in more than 100 countries around the world. Tickets for international locations outside North America will go on sale for most participating locations beginning September 26. Ticket prices will vary by country. The film is already scheduled to play in more than 4,000 movie theatres in the U.S., Canada, and Mexico, including of course in all AMC locations in the United States. When the film was first announced on August 31, it took less than 24 hours for the "Taylor Swift The Eras Tour" concert film to shatter AMC's U.S. record for the highest ticket-sales revenue during a single day in AMC's 103-year history. "Taylor Swift The Eras Tour" concert film will play at every ODEON Cinemas location throughout Europe. Additionally, AMC and its sub-distribution partners are taking steps to reach agreements with additional cinema operators throughout the world to play "Taylor Swift The Eras Tour".
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VZ | Hot Stocks08:05 EDT Verizon announces upgrades from multi-year transformation of network - Verizon has recently undergone a major multi-year transformation of its network architecture to provide customers with more capabilities, upgrade the technology in the network, pave the way for personalized customer experiences and provide a platform for enterprises and developers to drive innovation. While this massive undertaking is not over, the results have been unmistakable, with customers using the network in more places in more ways and having a better experience on the Verizon network.
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ARMP | Hot Stocks08:05 EDT Armata Pharmaceuticals: First patient dosed in Phase 2a portion of AP-SA02 study - Armata Pharmaceuticals announced that the first patient has been dosed in the Phase 2a portion of the company's diSArm study of AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia. Initiation of the Phase 2a portion of the study follows Data Review Committee review of positive safety and tolerability data from the Phase 1b portion. Armata has received a $16.3M award to advance development of AP-SA02 from the Department of Defense through the Medical Technology Enterprise Consortium managed by the Naval Medical Research Command with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.
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ECOR | Hot Stocks08:04 EDT electroCore expands IP portfolio for nVNS technology - electroCore announced the United States Patent and Trademark Office has issued a patent related to non-invasive nerve stimulation with mobile devices. U.S. Patent No. 11,766,562 entitled "Nerve Stimulator for Use with a Mobile Device" was issued on September 26, 2023, and is generally related to treating seizures, such as epileptic seizures that utilizes a system for transcutaneously stimulating a nerve within a patient whereby the system includes the stimulator and a mobile device that provides a wireless signal to enable the stimulator to operate.
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ICPT | Hot Stocks08:03 EDT Alfasigma to acquire Intercept for $19.00 per share in cash - Alfasigma S.p.A and Intercept Pharmaceuticals have entered into a definitive merger agreement under which Alfasigma has agreed to acquire Intercept for $19.00 per share in cash. The anticipated transaction will materially expand Alfasigma's gastrointestinal and hepatology portfolio and its presence in the U.S. market. Intercept's lead medicine is Ocaliva, a farnesoid X receptor agonist approved in the United States and several other jurisdictions for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Ocaliva is the only approved second-line therapy for PBC and has experienced double-digit year-over-year growth supported by an experienced specialty sales force and strong prescriber base. Intercept also benefits from a broader clinical development pipeline anchored by a novel fixed-dose combination of obeticholic acid and bezafibrate in phase 2 trials for PBC. Under the terms of the merger agreement, Alfasigma has agreed to commence a cash tender offer to acquire all issued and outstanding shares of Intercept common stock for $19.00 per share in cash. The purchase price represents a premium of 82% to Intercept's closing stock price on September 25, 2023. The transaction will be fully financed by Alfasigma's existing cash on hand and existing corporate credit facilities. The members of the Board of Directors of Intercept participating in the decision have unanimously approved the transaction. The closing of the tender offer will be subject to customary conditions, including the tender of shares which represent at least a majority of the total number of Intercept's outstanding shares of common stock and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Upon successful completion of the tender offer, Alfasigma would acquire all shares not acquired in the tender offer through a second-step merger for the same consideration that the tendering stockholders will receive in the tender offer. It is anticipated the transaction will close by the end of 2023. Upon completion of the transaction, Intercept's common stock will no longer be publicly listed.
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AZTA | Hot Stocks08:02 EDT Azenta's CFO Lindon Robertson retiring, Herman Cueto succeeds - Azenta announced that Herman Cueto will join Azenta as Executive VP and CFO, effective October 16. Cueto, who comes from BD, will succeed Azenta CFO Lindon Robertson, who is retiring and will remain as an advisor to facilitate a seamless transition. Cueto joins Azenta from BD, which he joined in 2017 through its acquisition of CR Bard. Mr. Cueto most recently served at BD as Senior Vice President of Finance, overseeing Segments / Regions / BP&A / Operations. He formerly served as Senior Vice President and Chief Financial Officer of BD's Medical Segment. Prior, Cueto was at CR Bard for fourteen years, most recently as Vice President and Group CFO.
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PLRX | Hot Stocks07:50 EDT Pliant announces Phase 2a INTEGRIS-PSC met primary, secondary endpoints - Pliant Therapeutics announced positive data from INTEGRIS-PSC, a Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis and suspected moderate to severe liver fibrosis. The trial met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a 12-week treatment period and its plasma concentrations increased with dose. The trial's exploratory efficacy endpoints assessed changes in the liver fibrosis markers, Enhanced Liver Fibrosis score and PRO-C3 levels, as well as liver biochemistry and magnetic resonance imaging of the liver. Results at the initial three doses tested showed bexotegrast reduced both ELF scores and PRO-C3 levels at Week 12 at all doses relative to placebo with statistically significant differences at the 160 mg dose relative to placebo at Week 12. Patients also showed stabilization of liver chemistry, including a dose-dependent trend in reduction of alkaline phosphatase levels, relative to placebo at Week 12. In addition, preliminary MRI imaging results suggest improved hepatocyte function and bile flow with bexotegrast 160 mg. Twelve-week interim data from the high-dose 320 mg cohort is expected in the first quarter of 2024. The primary endpoint of the INTEGRIS-PSC trial is the evaluation of the safety and tolerability of bexotegrast. The secondary endpoint is an assessment of its pharmacokinetics. Bexotegrast was well tolerated at all three doses tested. Of the 64 patients treated with bexotegrast, 60 completed 12 weeks of treatment with no deaths or drug-related severe or serious adverse events. Most treatment emergent adverse events were mild or moderate in severity and consistent with PSC disease symptoms. Patients in the trial who had concomitant inflammatory bowel disease saw no change in their IBD symptoms as measured by partial Mayo Score while on treatment. Bexotegrast total and unbound plasma concentrations increased with dose. A treatment effect was observed on ELF score in all bexotegrast dose groups. Bexotegrast reduced ELF scores relative to placebo at all doses, with a statistical significance achieved at the 160 mg dose. The bexotegrast 160 mg dose group demonstrated an 84% reduction of the change in ELF score relative to placebo at Week 12. Importantly, at the 160 mg dose group, statistically significant reductions were observed across all three components of the ELF score. Patients with PSC tend to have elevated or fluctuating liver biochemistry levels. Patients treated with bexotegrast showed stabilization of liver chemistry levels, including alanine aminotransferase and aspartate aminotransferase, as well as total and direct bilirubin, at all doses versus increases in placebo at Week 12. Additionally, bexotegrast-treated patients with elevated baseline ALP levels showed a dose-dependent trend in reduction in ALP relative to placebo at Week 12. Preliminary MRI imaging of the liver using gadoxedate contrast showed small increases in MRI relative enhancement from baseline across all dose groups, compared to a decrease observed in the placebo group to Week 12.
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DPRO | Hot Stocks07:49 EDT Energy research association selects Draganfly Commander 3XL Platform - Draganfly announces a leading energy research association has chosen Draganfly's Commander 3XL Platform for inspection standards operations.
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VSCO | Hot Stocks07:46 EDT Victoria's Secret presents 'The Tour '23' - Victoria's Secret is thrilled to announce that Victoria's Secret: The Tour'23 is now available to stream on Prime Video. Part documentary, part spectacular fashion event - the exclusive showcase will captivate audiences and provide a viewing experience that celebrates Victoria's Secret's mission to uplift and champion women all over the world. The reimagined fashion show takes Prime Video viewers on a journey through the creation of The Tour, with behind-the-scenes footage and intimate stories of the VS20 - a group of 20 innovative global creatives who conceived four fashion curations from the vibrant cities of Bogota, Lagos, London and Tokyo, alongside iconic custom Victoria's Secret designs. The Tour gives a new generation of creators from around the world the opportunity to tell their stories, reflect on their experiences and see their creations brought to life on the world stage.
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SLNO | Hot Stocks07:46 EDT Soleno announces statistically significant top-line results from Study C602 - Soleno Therapeutics announced positive top-line results from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR Extended-Release tablets for the treatment of Prader-Willi syndrome. Key Top-line Results: Hyperphagia-related behaviors markedly worsened in the placebo group compared to DCCR, represented by a highly statistically significant, clinically meaningful difference in mean change from baseline in the HQ-CT total score of 5.0 at week 16. Secondary endpoints of CGI-S and CGI-I both showed strong trends towards worsening in the placebo group compared to DCCR over the course of the randomized withdrawal period, respectively. DCCR continued to be generally well-tolerated in the randomized withdrawal period with no new or unexpected safety signals, including no serious adverse events or discontinuations due to adverse events occurring in any participants in the DCCR group.
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PROBF | Hot Stocks07:44 EDT Probe Gold awarded ECOLOGO certification - Probe Gold has received UL 2723 ECOLOGO Certification for Mineral Exploration Companies for following the best practices for responsible development in the mining exploration industry. Probe Gold began the accreditation process in February 2022 and successfully completed it in August 2023. This process involved developing and implementing internal policies and procedures, along with a comprehensive review of the documentation. The verification was conducted by UL Solutions, a globally recognized and respected scientific testing, inspection, and certification company specializing in standards development and certification.
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MGAM | Hot Stocks07:43 EDT Mobile Global Esports concludes MOGO National Championship 2.0 - Mobile Global Esports produced the 'MOGO National Championship 2.0.' Following the virtual qualifiers, the championship event at Lovely Professional University in Phagwara, India, featured outstanding competitive play from 16 teams representing four geographic regions, marking a significant milestone in collegiate esports. MOGO produced the esports championship in cooperation with Elite Power Sports, which produced the national basketball, volleyball, and kabaddi university championships. The championship rounds featured upsets, underdog victories and thrilling overtime matches, including one match that lasted 38 rounds. The week-long live, LAN event showcased the remarkable skill and determination of the participating student teams. What set this event apart was the exceptional pro-level experience that MOGO provided to all the participating teams.
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INZY | Hot Stocks07:41 EDT Inozyme announces data from trial of INZ-701 in adults with ABCC6 deficiency - Inozyme Pharma announced positive interim safety, pharmacokinetic, pharmacodynamic and exploratory efficacy data from the Company's ongoing Phase 1/2 clinical trials of INZ-701 in adults with ABCC6 Deficiency. ABCC6 Deficiency: Ten patients were enrolled in the ongoing Phase 1/2 trial across three dose cohorts of INZ-701. Exploratory Efficacy Data: Clinical outcome measures were collected to provide evidence of clinical benefit and to inform the design of future trials in adults. Notable changes in GIC, a PRO, were observed, including: The majority of timepoints showed improvement in GIC scores reported by P-GIC and C-GIC. All patients showed improvement on C-GIC, and 7/9 patients showed improvement from baseline on P-GIC at last follow-up. Pharmacodynamic and Pharmacokinetic Data: Rapid and significant increase in PPi levels observed in all cohorts with a dose response observed. PPi showed sustained increase in the highest dose cohort to levels comparable to those observed in a study of healthy subjects. PK properties were consistent with those observed in the Phase 1/2 clinical trial in adults with ENPP1 Deficiency. Safety Data: INZ-701 was generally well-tolerated and exhibited a favorable safety profile, with no serious or severe adverse events. All adverse events were mild to moderate in severity. 7/10 patients experienced adverse events related to INZ-701. Injection site reactions occurred in 7/10 patients. Other related adverse events were fatigue, night sweats and urticaria. One patient from the highest dose cohort was withdrawn from Phase 1 at day 18 due to a moderate adverse event related to INZ-701. One patient withdrew from the trial during Phase 2, which was not related to an adverse event. Eight patients remain in the trial and seven continue on home self-administration of INZ-701 treatment. Time on study ranged from 18 to over 518 days. Total time on treatment across all cohorts corresponds to approximately 9.1 patient-years. ADA Data: INZ-701 exhibited a favorable immunogenicity profile with low titers of non-neutralizing ADAs observed in 8/10 patients. The ADA levels were transient in 3/8 patients.
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PRSO | Hot Stocks07:41 EDT Peraso receives initial EOL purchase orders totaling $11.3M - Peraso has received purchase orders from multiple customers totaling $11.3M. These non-cancelable orders represent last-time buys received to-date associated with the previously announced end-of-life program for the Company's memory integrated circuit products. Peraso has commenced fulfillment of these orders and expects shipments to extend through 2024.
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INZY | Hot Stocks07:41 EDT Inozyme announces data from trial of INZ-701 in adults with ENPP1 deficiency - Inozyme Pharma announced positive interim safety, pharmacokinetic, pharmacodynamic and exploratory efficacy data from the Company's ongoing Phase 1/2 clinical trials of INZ-701 in adults with ENPP1 Deficiency. ENPP1 Deficiency: Nine patients were initially enrolled in the ongoing Phase 1/2 clinical trial across three dose cohorts of INZ-701. Exploratory Biomarker Data: Notable changes in key biomarkers were observed and support the clinical hypothesis, including: Meaningful reduction of fibroblast growth factor-23 observed. Serum phosphate levels increased over time, in the absence of phosphate and active vitamin D supplementation, which were withheld from patients during the study. Statistically significant correlation between increase in plasma pyrophosphate and decrease in FGF-23 observed at one week post first dose. Exploratory Efficacy Data: Outcome measures were collected to assess potential clinical benefit with ongoing treatment with INZ-701 and to inform the design and patient selection of future trials in adolescents and adults. Notable changes in PROs and functional outcomes were observed in all cohorts, including: Concordant improvement in GIC scores reported by patients and clinicians, and no patient showed a deterioration from baseline. High responder rates in Patient-Reported Outcome Measurement Information Scales of Pain Intensity, Fatigue and Pain Interference. Trend of improvement in 6-minute walk test. Subgroup analysis of 6-MWT results showed greater improvement in patients with lower baseline values and stable results over time in patients with higher baseline values. Subgroup analysis of patients who presented with arthritis/arthralgia at baseline showed improvement in 6-MWT, and increased spine bone mineral density and bone mineral content, as measured by dual x-ray absorptiometry. Pharmacodynamic and Pharmacokinetic Data: Rapid, significant, and sustained increase in PPi levels observed in all patients and significant elevation in PPi maintained for up to 18 months.Long half-life of approximately 126 hours and drug accumulation as shown by a greater than dose proportional exposure suggests the potential for once weekly dosing. Safety Data: INZ-701 was generally well-tolerated and exhibited a favorable safety profile, with no serious or severe adverse events attributed to INZ-701 and no adverse events leading to study withdrawal. 3/9 patients experienced mild adverse events related to INZ-701. Injection site reactions occurred in 2/9 patients.Other related adverse events included decreased appetite and fatigue. There were two serious adverse events not related to INZ-701. All nine patients enrolled in the Phase 2 portion of the trial, two of whom subsequently withdrew from the study. The study withdrawals were not related to an adverse event. Seven patients remain in the trial and continue on home self-administration of INZ-701 treatment. Anti-Drug Antibody Data: INZ-701 exhibited a favorable immunogenicity profile with low titers of non-neutralizing ADAs observed in 7/9 patients. The ADA levels were transient in 3/7 patients.
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DMTTF | Hot Stocks07:40 EDT Small Pharma reports topline data from SPL026-SSRI drug interaction study - Small Pharma announces safety, tolerability and efficacy data from its Phase Ib study exploring the interaction between selective serotonin reuptake inhibitors and SPL026, native N, N-dimethyltryptamine, in patients with Major Depressive Disorder. The purpose of this study was to build upon the previously reported Phase I/IIa safety and efficacy profile of SPL026 with support therapy, to assess whether SPL026 can be safely administered with or without SSRIs - the current standard of care for MDD. In the Phase I/IIa SPL026 study, patients were required to be withdrawn from SSRIs, which can be a disruptive experience. Through the SPL026-SSRI drug interaction study, Small Pharma aimed to address this requirement, which could enable broader patient recruitment on future large-scale studies, and potentially accelerate the clinical development pathway. Additionally, removing the requirement to be withdrawn from SSRIs may facilitate patient access to SPL026 earlier in the MDD treatment journey, if approved. This open-label study investigated the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of a single 27.5 mg intravenous infusion of SPL026, alone or in combination with SSRIs, in 171 patients, together with support therapy. The test cohort consisted of patients currently on a stable treatment course of SSRIs, which have been ineffective in fully relieving their depression symptoms. The control cohort consisted of patients not currently using any pharmacological treatment to treat their depression symptoms. Patients were recruited with moderate-severe MDD as defined by a Hamilton Depression Rating Scale score of greater than14. Efficacy was assessed using the Montgomery-Asberg Depression Rating scale to measure any change in patients' depression symptoms from baseline. Additional exploratory endpoints include the Beck Depression Inventory to assess patients' self-reported depression. Safety & Tolerability: SPL026 was well-tolerated by all patients in both the SSRI Cohort and Non-SSRI Cohort, with no apparent differences between cohorts; No drug-related serious adverse events reported; A small number of drug-related adverse events reported: 8 in SSRI Cohort; 3 in Non-SSRI Cohort; All deemed to be mild or moderate in severity; Majority of drug-related AEs were resolved during the dosing visit. The results reaffirmed the efficacy initially demonstrated in the Phase IIa SPL026 study. However, a marked improvement was observed between the antidepressant effect of SPL026 treatment in the SSRI Cohort compared to the Non-SSRI Cohort. While the efficacy observed in the Non-SSRI Cohort was comparable to the efficacy data previously observed in the Company's SPL026 Phase IIa clinical trial, the antidepressant effects observed in the SSRI Cohort were of a greater magnitude, suggesting a potentially enhanced efficacy effect when SPL026 is administered in combination with SSRIs.
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SYNH SNY | Hot Stocks07:37 EDT Syneos Health appoints Terttu Haring as president, clinical sites & patients - Syneos Health announced the appointment of Terttu Haring, MD, as President, Clinical Sites & Patients. With nearly 30 years of experience, Dr. Haring will lead the global clinical operations organization to drive exceptional delivery, quality and data integrity for customers, while ensuring a positive experience for sponsors, sites and patients. Her investigator background, and technology and data experience, will empower the Clinical Sites & Patients team to execute data-driven solutions that produce strong results for customers. Under Dr. Haring's guidance, Syneos Health will continue to nurture its heritage of scientific and therapeutic expertise across global clinical operations. Dr. Haring will also empower the Clinical Sites & Patients team to leverage the Company's in-depth local regulatory experience, with its expanding global footprint, to better connect patients and sites worldwide. Dr. Haring most recently held multiple leadership roles at Sanofi, with escalating responsibility across Clinical Research, Trial Operations and Data Management, and Clinical Innovation
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ABEO | Hot Stocks07:35 EDT Abeona Therapeutics submits BLA to FDA for EB-101 in RDEB - Abeona Therapeutics has submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval of EB-101, its investigational autologous, engineered cell therapy, as a treatment for patients with recessive dystrophic epidermolysis bullosa. As part of the submission, Abeona requested a Priority Review, which, if granted, would shorten the FDA's review period to six months from the filing acceptance of the BLA, instead of 10 months under standard review. The BLA submission for EB-101 followed ongoing discussions with the FDA and is supported by clinical efficacy and safety data from the pivotal Phase 3 VIITAL study and confirmatory evidence from a Phase 1/2a study. Data from the VIITAL study were presented during the inaugural International Societies for Investigative Dermatology Meeting in May 2023. Long-term follow up data up to eight years and quality of life data from the Phase 1/2a study were published in Orphanet Journal of Rare Diseases. The FDA's decision on BLA acceptance is typically made during the 60-day window following submission. If accepted with Priority Review, Abeona expects potential BLA approval in the second quarter of 2024, at which time, Abeona believes that it would be eligible to receive a Priority Review Voucher. The voucher, if granted, could be used by the Company to accelerate the review of a future BLA or New Drug Application, or be sold to a third party. EB-101 has been granted Rare Pediatric Disease, Regenerative Medicine Advanced Therapy, Breakthrough Therapy and Orphan Drug designations.
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REGN | Hot Stocks07:34 EDT Regeneron to acquire Metenova AB, terms not disclosed - Repligen Corporation entered into a definitive agreement to acquire privately-held Metenova AB of Molndal, Sweden. Metenova is projected to generate revenues of $24 million to $25 million for fiscal year 2023, led by the success of its magnetic mixing and drive train technologies that are widely used by global biopharmaceutical companies and contract development and manufacturing organizations. The company recently entered the single-use mixing market with the launch of its MixOne platform, leveraging the success of its existing stainless steel product line. Metenova is expected to contribute approximately $5 million in revenue to Repligen in the fourth quarter of 2023, and to contribute $25 million to $27 million in revenue in 2024, with 20%-25% revenue growth in 2025 forward. The acquisition is anticipated to be accretive to Repligen's adjusted gross and operating margins in 2024, and to be accretive to adjusted earnings per share in 2025. Over the past decade, Metenova has established market leadership through design innovation in magnetic mixing, with a state-of-the-art suite of both stainless steel and single-use impellers and drive trains - key components of mixing vessels. The company offers a broad range of products, including high power solutions for efficient media and buffer preparation, and low shear solutions for gentle mixing of sensitive proteins. Metenova's high performance aseptic mixing technologies are designed to minimize product damage and improve product yield and product consistency, contributing to improved ROI for customers. The company's solutions are applicable to a wide range of small molecule and large molecule therapeutics and vaccines, including monoclonal antibodies, recombinant proteins, and cell and gene therapies. The transaction is expected to be completed in the coming weeks, subject to the satisfaction of customary closing conditions. The transaction is a combination of cash and equity; to fund the cash component of the transaction, Repligen intends to use a portion of its cash on hand, which totaled approximately $604 million at June 30, 2023. Perella Weinberg Partners LP is acting as financial advisor, with Advokatfirman Vinge KB and Goodwin Procter LLP serving as legal counsel to Repligen. J.P. Morgan Securities PLC is acting as the financial advisor and Setterwalls Advokatbyrundefined is serving as the legal counsel to Metenova for the transaction.
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CYBN | Hot Stocks07:33 EDT Cybin announces agreement with Fluence to support scaling of Embark training - Cybin announced an agreement with Fluence to support the streamlining and scaling of Cybin's Embark facilitator training program in preparation for a multi-site, global Phase 3 trial of CYB003, its proprietary deuterated psilocybin analog in development for the potential treatment of major depressive disorder, or MDD. This streamlined model of psychedelic facilitation training, known as Embark for Clinical Trials, is designed for individuals with existing experience, knowledge, and skills in psychedelic facilitation. Under the terms of the agreement, Fluence will support Cybin in the selection and training of facilitators for the planned Phase 3 trial. Fluence will also create supplemental video content and provide asynchronous and synchronous training in service of augmenting and verifying facilitator competencies.
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SIRI LSXMA | Hot Stocks07:30 EDT Sirius XM down 4% after Liberty Media proposes combination deal - Shares of Sirius XM (SIRI) are down 18c, or 4%, to $3.83 in pre-market trading after Liberty Media announced that it communicated a proposal to the Special Committee of the Board of Directors of Sirius XM which outlined the terms of a proposed combination of Liberty Media's Liberty SiriusXM tracking stock group (LSXMA) with Sirius XM to form a new, consolidated public company.
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MANU | Hot Stocks07:30 EDT Manchester United up 4% after Bloomberg says Ratcliffe reworking buyout offer
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JKS | Hot Stocks07:30 EDT JinkoSolar announces cash dividend of $1.50 per American Depositary Share - JinkoSolar announced that its board of directors has declared a cash dividend of 37.5c per ordinary share of $0.00002 each of the company, or $1.50 per American Depositary Share. Holders of the Ordinary Shares or ADSs at the close of trading on November 24, 2023 will be entitled to receive the cash dividend. Dividend to be paid to the company's ADS holders through the depositary bank will be subject to the terms of the deposit agreement, including the fees and expenses payable thereunder. The dividend is expected to be paid on or around December 6, 2023. The total amount of cash to be distributed for the dividend is expected to be approximately $77M.
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LSXMA... | Hot Stocks07:19 EDT Liberty proposes combination with Sirius XM - Liberty (LSXMA) announced that it communicated a proposal to the special committee of the board of directors of Sirius XM (SIRI), which outlined the terms of a proposed combination of the Liberty SiriusXM tracking stock group with SiriusXM to form a new, consolidated public company. In the proposed transaction, Liberty would separate LSXM by means of a redemptive split-off of a newly formed subsidiary of Liberty, which would own all of the assets and liabilities attributed to LSXM. In the split-off, holders of each series of LSXM common stock would receive a number of shares of a single series of common stock of SplitCo calculated based upon each underlying share of SiriusXM common stock held by SplitCo being exchanged for 1.05 shares of common stock of New SiriusXM. SplitCo would then combine with SiriusXM to form New SiriusXM, with the minority shareholders of SiriusXM receiving shares in New SiriusXM on a one-for-one basis. In addition, the minority shareholders of SiriusXM would receive a pro rata cash payment calculated based on the amount of the outstanding net debt of LSXM effectively assumed by New SiriusXM in the proposed transaction. New SiriusXM would have a single outstanding series of common stock, with each share entitling the holder thereof to one vote per share. By way of example, based on recent outstanding share counts, holders of LSXM common stock would receive 10.3 shares of New SiriusXM common stock for each share of LSXM common stock held at closing, and, based on the projected outstanding principal amount of LSXM net debt at year end, the minority shareholders of SiriusXM would receive one share of New SiriusXM common stock plus 55c in cash for each share of SiriusXM common stock held at closing. The minority shareholders of SiriusXM would collectively own approximately 16% of New SiriusXM, and the former holders of LSXM common stock would collectively own approximately 84% of New SiriusXM. The proposed transaction is intended to be tax-free and would be subject to, among other things, the negotiation and execution of mutually acceptable definitive transaction documents and applicable board approvals, including the approval of a Special Committee. No further updates on the proposed transaction will be provided unless and until definitive documents are executed or discussions between the parties terminate. The proposed transaction would not result in any changes to the Liberty Formula One tracking stock group or the Liberty Live tracking stock group.
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LASE | Hot Stocks07:15 EDT Laser Photonics:U.S. Army buys cleantech laser cleaning system for Fort Liberty - Laser Photonics announced it finalized an order from Fort Liberty, one of the largest military installations in the world, for an LPC-3000-CTHD CleanTech laser blasting system for fleet and equipment maintenance. "This is the first 3000-CTHD laser cleaning system that we have sold to the Army," commented Wayne Tupuola, CEO of Laser Photonics. "Our CleanTech and DefenseTech products continues to help the military stay mission-ready by providing cutting-edge, eco-friendly technology that meets military standards." The CleanTech LPC-3000-CTHD is the most powerful laser cleaning system the military has bought from Laser Photonics to date. Fort Liberty, formerly known as Fort Bragg and several other military facilities, chose Laser Photonics as their supplier for laser cleaning technology due to the company's dependable, effective, and easy-to-implement products. Operators at the base will utilize the technology to maintain and clean vehicles and other equipment in a time-efficient and cost-effective manner
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LSXMA SIRI | Hot Stocks07:15 EDT Liberty Media proposes to combine Liberty SiriusXM with Sirius XM - In a regulatory filing, Liberty Media disclosed that on September 22, Liberty Media communicated a proposal to the Special Committee of the Board of Directors of Sirius XM (SIRI) which outlined the terms of a proposed combination of Liberty Media's Liberty SiriusXM tracking stock group (LSXMA) with Sirius XM to form a new, consolidated public company. "In the proposed Combination, the Reporting Person would separate LSXM by means of a redemptive split-off of a newly formed subsidiary of Liberty, 'SplitCo,' which would own all of the assets and liabilities then attributed to LSXM. In the Split-Off, holders of each series of LSXM common stock would receive a number of shares of a single series of common stock of SplitCo calculated based upon each underlying share of Common Stock held by SplitCo being exchanged for 1.05 shares of New SiriusXM common stock. SplitCo would then combine with the Issuer to form New SiriusXM, with the minority shareholders of the Issuer receiving shares in New SiriusXM on a one-for-one basis. In addition, the minority shareholders of the Issuer would receive a pro rata cash payment calculated based on the amount of the outstanding net debt of LSXM effectively assumed by New SiriusXM in the proposed transaction. New SiriusXM would have a single outstanding series of common stock, with each share entitling the holder thereof to one vote per share. By way of example, based on recent outstanding share counts, holders of LSXM common stock would receive 10.3 shares of New SiriusXM common stock for each share of LSXM common stock held at closing, and, based on the projected outstanding principal amount of LSXM net debt at year end, the minority shareholders of the Issuer would receive 1 share of New SiriusXM common stock plus $0.55 in cash for each share of Common Stock held at closing. The minority shareholders of the Issuer would collectively own approximately 16% of New SiriusXM, and the former holders of LSXM common stock would collectively own approximately 84% of New SiriusXM. The Combination is intended to be tax-free, except with respect to any cash received, and would be subject to, among other things, the negotiation and execution of mutually acceptable definitive transaction documents and applicable board approvals, including the approval of a Special Committee. No further updates on the Proposal or the proposed Combination will be provided unless and until definitive documents are executed or discussions between the parties terminate, or unless otherwise required by applicable law," the filing stated. Reference Link
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NB | Hot Stocks07:13 EDT NioCorp announces delay in filing annual financial statements - NioCorp Developments anticipates a delay in filing its annual financial statements for the year ended June 30, 2023, the related management's discussion and analysis, and the CEO and CFO certifications relating to the annual financial statements before the September 28, 2023 deadline. The closing of the Company's previously announced business combination with GX Acquisition Corp. II, and the ongoing complexities in integrating GX and accounting for the Business Combination has resulted in the anticipated delay in filing the Required Documents. The Company has applied to the Ontario Securities Commission, as principal Canadian regulator for the Company, for the imposition of a management cease trade order under National Policy 12-203 - Management Cease Trade Orders throughout the duration of the default. The MCTO, if approved, would generally not affect the ability of persons who are not management of the Company to trade in its securities. While no assurance can be given that the MCTO will be issued, the Company's existing Insider Trading Policy prohibits any and all trading by Company employees until at least three days following the filing of the Required Documents. The OSC may issue a general cease trade order against the Company for failure to file the Required Documents within the prescribed time period or sooner if the Company fails to file its status reports during the prescribed time limits. The Company confirms that it will satisfy the provisions of the alternative information guidelines under NP 12-203 by issuing bi-weekly default status reports in the form of news releases for so long as it remains in default of the above-noted filing requirements and further confirms there is no other material information relating to its affairs that has not been generally disclosed. NioCorp's management is working diligently to remedy the situation and anticipates the Required Documents will be filed as soon as they are available, likely by October 6, 2023. As a U.S. Securities and Exchange Commission reporting issuer, NioCorp anticipates filing a Form 12b-25 Notice of Late Filing with the SEC on or before September 29, 2023, to provide for an extension to file its Annual Report on Form 10-K through October 13, 2023.
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AMWL | Hot Stocks07:12 EDT Amwell and HealthGorilla announce new lab capability with Converge platform - Health Gorilla and interoperability solution provider Amwell announce a new lab capability within the Amwell Converge virtual care platform. Providers practicing on the Converge platform will be able to offer patients a more connected hybrid care experience through streamlined lab processes, enhanced digital diagnostic data capabilities, and access to a broader nationwide lab network. An individual's medical journey is highly dependent on diagnostic lab results. Up to 70% of clinical decisions are influenced by laboratory results1 and approximately 30% of patient encounters result in a provider ordering a lab test..."Health Gorilla's lab automation system is leveraged by leading provider organizations to automate their clinical workflows, and we're thrilled to add Amwell as our newest collaborator," said Steve Yaskin, chief executive officer at Health Gorilla. "Labs are a critical variable in the patient's care journey, and we're proud to empower providers using the Amwell Converge platform with more access to diagnostic data."
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DECPF | Hot Stocks07:12 EDT Diversified Energy announces increase in borrowing base - Diversified Energy announced its completion of the semi-annual borrowing base redetermination for the Company's revolving credit facility, structured as a Sustainability-Linked Loan. The borrowing base under the facility was increased to $425 million from $375 million with 100% approval from Diversified's 14-bank lending syndicate, resulting in current liquidity of approximately $120 million.
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LFSWF | Hot Stocks07:11 EDT Lifeist Wellness' Mikra introduces new mental health product - Lifeist Wellness provided a corporate update for its U.S. biosciences subsidiary Mikra Cellular Sciences including the development of a new and proprietary supplement aimed at supporting the mental health issue of anxiety. "We are pleased to share an update on the continued progress of our U.S. biosciences subsidiary, Mikra Cellular Sciences Inc.," said Meni Morim, CEO of Lifeist. "Mikra's mission is to enhance vigorous lifespan and well-being by focusing on cellular health. Toward that goal, we have developed a new supplement to help support mental wellness, a pressing global concern. We are building off the success of our flagship product, CELLF which utilizes bioactive compounds to impact various bodily systems, reflecting our commitment to evidence-backed innovation. CELLF's availability on Amazon marks a significant expansion of distribution channels, with initial sales showing promising growth. We look forward to sharing more details about our new mental health product as we work to finalize the lab formulation in the 4th quarter." After the launch of CELLF and its improved version CELLF v1.2, a cellular health nutraceutical gel formulated with bioactive compounds to positively impact your brain, heart, skin and muscular systems, Mikra is dedicated to unveiling innovative products that add healthy, active, and high-quality years to one's life. It is currently in the formulation finalization phase of achieving a proprietary supplement aimed at supporting mental health among those who wrestle with anxiety. This initiative is in direct response to the growing worldwide emphasis on mental well-being and the "quiet epidemic" of anxiety among young adults, caused by the unprecedented pressures of life in the 21st century which have brought mental health to the forefront.1 Mikra is committed to leading the way in exploring natural supplements to help support our customers in their journey, without the adverse side effects of harsh and habit-forming pharmaceutical interventions.
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TTOO | Hot Stocks07:11 EDT T2 Biosystems investor CR Group sells $1.9M in common stock - In a regulatory filing last night, T2 Biosystems disclosed that CR Group sold 6.3M shares of common stock on September 21st in a total transaction size of $1.9M. Shares of T2 are down 3% in pre-market trading.
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AMLI | Hot Stocks07:09 EDT American Lithium announces new lithium discovery near Quelcaya - American Lithium announces a new lithium discovery from the initial drill hole completed at one of the key discovery targets previously identified from 2021 field work conducted near the Community of Quelcaya. Simon Clarke, CEO of American Lithium, states, "We are very excited with this discovery drill hole at Quelcaya. The lithium mineralization is in rocks that are texturally and geologically distinct from the Falchani tuff mineralization, but are obviously related to the same 8-million-year-old volcanic activity responsible for Falchani. The potential scale of this area of lithium mineralization is very large given the thickness seen in the discovery hole. The potential to pre-concentrate the lithium in this style of mineralization is also very encouraging as we start to analyze the leachability and economic potential. This discovery also validates our thesis that the Macusani Plateau hosts more than just the Falchani lithium deposit and has the potential to become a major lithium district, which we control."
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VIGL | Hot Stocks07:08 EDT Vigil Neuroscience receives positive opinion from EMA on ODD for VGL101 - Vigil Neuroscience announced that the Committee for Orphan Medicinal Products, COMP, of the European Medicines Agency, EMA, has issued a positive opinion on the Company's application for orphan drug designation, ODD, for VGL101 for the treatment of CSF1R-related leukoencephalopathy, which includes adult-onset leukoencephalopathy with axonal spheroids and pigmented glia, ALSP. The Company is currently evaluating VGL101 in a Phase 2 proof-of-concept trial in patients with ALSP. VGL101 was previously granted orphan drug designation by the U.S. Food and Drug Administration for ALSP in July 2022. "Receiving a positive opinion for orphan drug designation for VGL101 in the EU is a tremendous achievement in our efforts to develop a therapy for individuals living with ALSP, which affects approximately 13,000 people in the EU," said Ivana Magovevi-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. "ALSP is a rare and rapidly progressive neurodegenerative disease with no approved treatment. We are committed to advancing our program through clinical development and bringing this potentially transformative therapy to these patients as quickly as possible."
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AVTX HRZN | Hot Stocks07:08 EDT Avalo Therapeutics eliminates $35M debt - Avalo Therapeutics (AVTX) announces the payoff of the remainder of its $35 million debt owed to Horizon Technology Finance Corporation (HRZN). This significant milestone not only signifies the company's steadfast commitment to financial stability but also paves the way for future accelerated growth and progress toward executing its ambitious plans to advance its most promising drug candidates, including its anti-LIGHT mAb and its BTLA agonist fusion protein
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TLSA | Hot Stocks07:07 EDT Tiziana Life Sciences initiates Phase 2a trial of intranasal foralumab - Tiziana Life Sciences announced that it held an Investigator's Meeting with principal investigators at Brigham and Women's Hospital to begin site initiation for its lead intranasal foralumab program entering Phase 2a clinical testing in non-active Secondary Progressive Multiple Sclerosis, na-SPMS, patients. In total, six to ten new clinical trial sites will be recruited. Matthew Davis, M.D., RPh, Chief Operating Officer and Chief Medical Officer of Tiziana Life Sciences, stated, "As planned for this quarter, we are on track and have begun site initiation visits so patient enrollment begins in this critical clinical trial. Advancing our lead anti-CD3 therapeutic, foralumab, in na-SPMS into Phase 2a will enable Tiziana to define novel endpoints, such as PET imaging, a similar target endpoint in our Expanded Access program. We are encouraged as five out of six patients in our open-label EAP have improved by qualitative analysis in their PET scans compared to baseline. Phase 2a na-SPMS study assesses the same outcome measure, but now, and for the first time for this novel therapeutic, in a double-blind, randomized placebo control, a multi-center trial is now underway."
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ANTX | Hot Stocks07:07 EDT AN2 Therapeutics geta Bill & Melinda Gates Foundation grant for TB & Malaria - AN2 Therapeutics announced that it has received a research grant from the Bill & Melinda Gates Foundation to discover novel, boron containing small molecules for the treatment of tuberculosis and malaria. Funding from the Gates Foundation will support the discovery of novel inhibitors of aminoacyl-tRNA synthetases using AN2's proprietary boron chemistry platform. AN2's boron chemistry has the potential to address biological targets for tuberculosis and malaria that build on the scientific expertise of several AN2 scientists that were involved in discovering novel leucyl-tRNA synthetase inhibitors including epetraborole, tavaborole, as well as ganfeborole, which is currently in development for tuberculosis. AN2's boron chemistry platform has demonstrated success against leucyl- tRNA synthetase, a target that has proven difficult to inhibit using traditional medicinal chemistry approaches. " ...This grant underscores our commitment to address areas of high unmet need in global health and capture synergies with our existing research programs using non-dilutive funding."
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FINGF | Hot Stocks07:07 EDT Finning International to host Investor Day, Tour - Finning International is hosting its Investor Day on September 26, 2023 in Antofagasta, Chile starting at 7:30 AM Eastern Time. "We are pleased to welcome investors and analysts to the Antofagasta mining region in Chile. We look forward to introducing our global leadership team and refreshed strategy, as well as demonstrating our strong local leadership and capabilities in this exciting growth region. We have significantly exceeded our 2021 Investor Day Plan. The strong operational execution by this management team has transformed our return on invested capital and earnings capacity today and for the future. Our refreshed strategy will build upon this success and will focus on the following priorities: drive product support, full-cycle resilience, and sustainable growth," said Kevin Parkes, president and CEO of Finning International. The company said, "Our product support business is our key value driver and remains by far the largest opportunity for resilient, profitable growth. We are working to capture an even greater share of the product support opportunity across the full asset life cycle through further penetration of customer value agreements, expanding our rebuild business, and continuing to strategically grow our equipment population. On a consolidated basis, we are targeting greater than 7% compounded annual growth of our product support revenue from the last twelve months ended Q2 2023 through 2025...Having a lower and more flexible cost and invested capital base are critical enablers of greater earnings consistency. We have made excellent progress reducing our cost base and are pleased with our SG&A as a percentage of net revenue reaching 17% over the last twelve months ended Q2 2023. This is an area of continuous improvement, and we are well on our way to reducing our SG&A as a percentage of net revenue below 17% in a steady growth environment. Our immediate top priority is to increase our invested capital turns while concurrently improving customer service levels. This will be achieved through a combination of systematic improvements in working capital velocity as supply chain normalizes, as well as optimizing lower ROIC activities. We are targeting invested capital turns of 2.3 to 2.5 times by the end of 2025. In a steady growth environment, we expect our invested capital improvement plan to unlock more than $450 million of capital...As we reinvest in our business, we will continue to grow product support and place a greater emphasis on capturing attractive opportunities in the used, rental, and power systems segments. Growth in these segments is supported by strong mega trends, and we are optimally positioned in our territories to benefit from these large addressable markets. We are building our capabilities in these areas and see opportunities to deploy capital with attractive returns through 2025 and beyond."
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OMGA | Hot Stocks07:06 EDT Omega Therapeutics announces preliminary clinical data for OTX-2002 - Omega Therapeutics announced encouraging preliminary safety, tolerability, pharmacokinetic and translational data from the initial two dose level cohorts from Part 1 of its ongoing Phase 1/2 MYCHELANGELO I study evaluating OTX-2002 in patients with hepatocellular carcinoma and other solid tumors associated with the c-MYC gene. Key Highlights: Translational: Highly specific on-target engagement and intended epigenetic changes at the target genomic loci were observed for all eight patients across both dose levels, as evidenced by a robust increase in cell-free DNA MYC methylation signal following administration with OTX-2002. The increased methylation signal persisted throughout the two-week dosing interval. Epigenetic modulation of MYC translated to rapid, robust and durable downregulation of MYC expression in all eight patients, with mean reductions across both dose levels of approximately 55% observed 7 days following administration with OTX-2002. The increase in methylation and corresponding downregulation of MYC expression observed clinically are within the ranges that led to anti-tumor activity in preclinical xenograft models. Pharmacokinetics: Consistent pharmacokinetic data across both dose levels with rapid clearance and minimal variability observed within and between patients. No accumulation was observed following repeat administration, and low, transient levels of immune response were observed with no related adverse events or impact on PK observed. Both initial dose levels are below the predicted threshold for anti-tumor activity based on preclinical models. Safety and Tolerability: At both dose levels, OTX-2002 was generally well tolerated, with no dose-limiting toxicities.The majority of adverse events observed in the trial were grade 1 or 2. The most common treatment-related adverse events were infusion-related reactions including fever and chills, generally consistent with the known profile of other FDA-approved LNP-delivered therapeutics.
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MASS | Hot Stocks07:04 EDT 908 Devices enters into initial production phase of DoD AVCAD program - 908 Devices announces that it has entered the initial production phase of the Aerosol and Vapor Chemical Agent Detector, AVCAD, program. The company and its partner on the project, Smiths Detection, will initially produce 122 systems in this next phase..."908 Devices is pleased to continue working with the U.S. Department of Defense and our partner, Smiths Detection, on this enterprise, multi-year program," said Kevin J. Knopp, CEO and Co-founder of 908 Devices. "Being selected for this limited production phase validates our technology as a new standard for chemical detection and we are truly honored to have a role in protecting our U.S. military." ..."908 Devices is pleased to continue working with the U.S. Department of Defense and our partner, Smiths Detection, on this enterprise, multi-year program," said Kevin J. Knopp, CEO and Co-founder of 908 Devices. "Being selected for this limited production phase validates our technology as a new standard for chemical detection and we are truly honored to have a role in protecting our U.S. military."
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AMWL | Hot Stocks07:04 EDT Amwell, Health Gorilla announce expanded digital diagnostic lab ordering - Health Gorilla and Amwell announce a new lab capability within the Amwell Converge virtual care platform. Providers practicing on the Converge platform will be able to offer patients a more connected hybrid care experience through streamlined lab processes, enhanced digital diagnostic data capabilities, and access to a broader nationwide lab network.
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MDWD | Hot Stocks07:04 EDT MediWound secures additional U.S. DoD funding of $6.5M to advance NexoBrid - MediWound announced that the U.S. Department of Defense, DoD, through the Medical Technology Enterprise Consortium, MTEC, has awarded MediWound additional funding to develop NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army. The $6.5M project budget will advance the development of a new, temperature stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings. "We are honored to further our collaboration with the U.S. Department of Defense. Our shared vision of enhancing treatment outcomes for traumatic burns on the battlefield will ensure NexoBrid's availability for military use," said Ofer Gonen, Chief Executive Officer of MediWound. "This additional funding reinforces NexoBrid's standing as the non-surgical, temperature stable, user-friendly, and highly effective solution for eschar removal, emphasizing its game-changing potential in early severe burn treatment protocols.
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IONS | Hot Stocks07:03 EDT Ionis Pharmaceuticals' olezarsen meets primary Phase 3 efficacy endpoint - Ionis Pharmaceuticals announced positive topline results for the Phase 3 Balance study of olezarsen in people with familial chylomicronemia syndrome - FCS -. The trial met its primary efficacy endpoint with a statistically significant reduction in triglyceride levels with the olezarsen 80 mg monthly dose at six months compared to placebo; triglyceride lowering continued to improve at 12 months. In addition, olezarsen 80 mg showed a 100% reduction in acute pancreatitis events compared to placebo, a key secondary endpoint. Treatment with olezarsen 80 mg resulted in a greater than75% reduction in apoC-III, a protein produced in the liver that regulates TG metabolism in the blood. Olezarsen demonstrated a dose-dependent effect, with both study doses showing a substantial reduction in pancreatitis. The lower 50 mg dose did not reach statistical significance at six months on the primary endpoint of triglyceride lowering. Ionis plans to file a New Drug Application in early 2024 with the FDA in addition to EU regulatory filings. If approved, olezarsen would be the first available treatment in the U.S. for FCS, a rare, debilitating genetic disease that can lead to acute, potentially fatal pancreatitis attacks. The FDA granted olezarsen Fast Track designation for the treatment of FCS in 2023. Olezarsen demonstrated a favorable safety and tolerability profile in the study. There were more adverse events in the placebo group compared to the olezarsen groups, primarily due to pancreatitis events.
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GXO | Hot Stocks07:02 EDT GXO Logistics extends partnership with VTech - GXO Logistics extended its partnership with VTech. GXO's site in West Hallam dedicates 115,000 square feet of warehouse space to VTech operations, which include ecommerce, picking and packing, recycling, returns management and value-added services. The facility stores approximately 1.2 million units of electronic learning toys and over 100,000 units of telecom products. As part of its service, GXO has facilitated flexible delivery options to help VTech grow its sales in the UK & Ireland.
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GP | Hot Stocks07:02 EDT GreenPower Motor reports results from EV school bus pilot program in W. Virginia - GreenPower Motor recently announced the results from its successful all-electric school bus pilot program conducted in West Virginia that resulted in subsequent all-electric school bus orders. GreenPower shared its findings along with helpful data to improve future deployments at the Green Bus Summit held during STN EXPO in Reno, Nevada this summer. "The GreenPower all-electric school buses did what they were supposed to do throughout the entire pilot. The buses transported the kids to school in the morning, home safely at night, and in some cases, on to football games or other extracurricular activities," GreenPower Vice President of Business Development and Strategy Mark Nestlen said in releasing the program results. "There was no case where the buses failed to perform nor meet the demands of the school districts and drivers." As a result of the successful pilot program and the performance of the GreenPower vehicles, schools in the Mountain State have placed orders to purchase GreenPower all-electric, purpose-built school buses to deploy in their fleets, and have also asked to receive GreenPower school buses purchased by the state. Several of the pilot program counties have applied for new funding through the EPA and other sources to purchase additional GreenPower school buses as well.
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SPOT | Hot Stocks06:59 EDT Spotify introduces Jam real-time collaborative listening session - In a company blog post, Spotify said, "Today we're introducing Jam, a personalized, real-time listening session for your group to tune into together. Jam builds on some of our popular social features and combines them with our personalization technology to take real-time listening with pals to the next level. With Jam, Premium subscribers will be able to invite others to contribute through a shared queue and enjoy a musical experience made exclusively for everyone listening...Jam is rolling out for all Spotify users globally starting today-so make sure your app is up-to-date. Premium listeners everywhere can start a Jam and anyone on Spotify can join. Simply invite your squad and Jam will help you find the perfect songs to add to the queue, finding the overlaps in your listening preferences to deliver music recommendations that everyone will love. You'll have the ability to see who's added which track so you know whom to thank for that crowd pleaser, whether you're prepping food together in the kitchen or enjoying games in the backyard. Once you start a Jam, you can invite a group of friends or family-Free or Premium users, or a mix-so they can share the experience. Premium listeners can join from wherever they are, whether they're in the same room or across the world." Reference Link
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BLCO | Hot Stocks06:59 EDT Bausch + Lomb launches LUMIFY EYE ILLUMINATIONS in U.S. - Bausch + Lomb announced the U.S. launch of LUMIFY EYE ILLUMINATIONS, a new line of hypoallergenic specialty eye care products scientifically developed to cleanse, nourish and brighten the sensitive eye area.
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ACM | Hot Stocks06:58 EDT Aecom joint venture selected by Department of Interior's Orphaned Well Program - Aecom's SLICOM joint venture with managing partner Street Legal Industries has been awarded an indefinite delivery, indefinite quantity contract by the U.S. Department of Interior Bureau of Land Management to support the government's Federal Orphaned Well Program. The multi-state, multi-agency program-supported by $4.7B in funding through the Infrastructure Investment and Jobs Act, addresses the risks to human and environmental health from abandoned oil and gas wells in federal lands throughout the United States. The SLICOM joint venture will deliver a range of services required for remediation following more than 150 years of oil and gas production on federal lands nationwide. A major initiative within the program is mitigating harmful methane pollution, which is a key contributor to climate change. Street Legal Industries is an 8(a), woman-owned small business that is participating in the U.S. Small Business Administration mentor-protege program with Aecom as their large business mentor.
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UNFI | Hot Stocks06:57 EDT United Natural Foods appoints three new independent directors to board - United Natural Foods announced the addition of three new members to its Board of Directors as part of the company's ongoing customer and supplier focused transformation plan and commitment to strong corporate governance and shareholder value creation. Effective September 28, 2023, Lynn Blake, James "Jim" Loree and James Pappas will join UNFI's Board as new independent directors. In addition, in connection with a Cooperation Agreement UNFI entered with JCP, the Board will also oversee a financial review designed to enhance the company's performance and drive shareholder value creation. Both actions are aimed at accelerating UNFI's transformation and positioning the company for both near- and long-term success.
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ITRG | Hot Stocks06:51 EDT Integra Resources updates mineral resource estimate at DeLamar - Integra Resources is pleased to announce an updated Mineral Resource Estimate for the DeLamar and Florida Mountain Deposits located in southwestern Idaho that incorporates the results from the highly successful stockpile drill program completed in April 2023. The stockpile drill program added a Measured and Indicated resource of 504,000 ounces gold equivalent and an Inferred resource of 46,000 oz AuEq. The mineralized stockpile and backfill material that was incorporated into the updated DeLamar MRE demonstrates the potential for this material to significantly increase the heap leach mine life in future phases. The updated DeLamar MRE increased the total heap leachable oxide-and-mixed ounces within the M&I category by ~25% and increased the total Inferred ounces by ~31%. In total, ~90% of the updated MRE falls within the M&I category, highlighting the quality and scarcity of projects such as DeLamar in the prolific Great Basin mining district of the USA.
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SUNL | Hot Stocks06:51 EDT NYSE to start delisting proceedings against Sunlight Financial - The New York Stock Exchange announced that the staff of NYSE Regulation has determined to commence proceedings to delist the securities of Sunlight Financial Holdings from the NYSE. Trading in the company's securities will be suspended immediately. "NYSE Regulation reached its decision to delist the company's securities pursuant to Section 802.01B of the NYSE's Listed Company Manual because the company had fallen below the NYSE's continued listing standard requiring listed companies to maintain an average global market capitalization over a consecutive 30 trading day period of at least $15,000,000. The company has a right to a review of this determination by a Committee of the Board of Directors of the Exchange. The NYSE will apply to the Securities and Exchange Commission to delist the securities upon completion of all applicable procedures, including any appeal by the company of the NYSE Regulation staff's decision," the exchange stated. Reference Link
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GOOG GOOGL | Hot Stocks06:51 EDT Google to end Gmail's Basic HTML view in 2024 - Google is sunsetting Gmail's Basic HTML view, which enables users to look at their emails in a barebones state. On a company support page, Google said, "You can display Gmail on your browser in Basic HTML view until January 2024. After this date, Gmail automatically changes to Standard view." Reference Link
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TRMB | Hot Stocks06:45 EDT Trimble, Kyivstar partner to install new CORS network - Trimble and Kyivstar are partnering to install a new Continuously Operating Reference Station, or CORS, network to provide Global Navigation Satellite System, or GNSS, correction services across the country. Available to users as an annual subscription service, the new network will be built using Trimble's hardware and software positioning technology.
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VERV | Hot Stocks06:37 EDT Verve Therapeutics to present Phase 1b data on HeFH candidate - Verve Therapeutics will present interim data from its ongoing heart-1 Phase 1b clinical trial of VERVE-101 for patients with high-risk heterozygous familial hypercholesterolemia - HeFH - in a late-breaking science presentation at the American Heart Association's Scientific Sessions 2023 in Philadelphia November 11-13. VERVE-101 is a base editing medicine designed as a single-course treatment that inactivates the PCSK9 gene in the liver to durably reduce disease-driving low-density lipoprotein cholesterol - LDL-C -. VERVE-101 is being developed initially as a treatment for patients with HeFH, a prevalent and potentially life-threatening genetic cardiovascular disorder that causes life-long severely elevated LDL-C, leading to increased risk of early-onset atherosclerotic cardiovascular disease. heart-1 is a Phase 1b clinical trial designed to evaluate the safety and tolerability of VERVE-101 in single ascending dose cohorts of the highest risk patients with HeFH, established ASCVD, and uncontrolled LDL-C levels on oral standard-of-care therapy. In addition, the clinical trial is designed to measure PCSK9 protein and LDL-C changes in patients and assess the potential for early proof-of-concept of the ability to base edit in the liver. At AHA, Verve expects to report initial safety and pharmacodynamic data, as well as blood PCSK9 and blood LDL-C levels, from patients across four SAD cohorts.
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AULT | Hot Stocks06:33 EDT Ault Inc. to acquire majority stake in Eco Pack Technologies - Ault Alliance's wholly owned subsidiary, Eco Pack Technologies, Inc., has entered into an agreement to acquire an 80% ownership stake in Eco Pack Technologies LTD. Eco Pack offers eco-centric packaging alternatives. Using digital technology enabling data driven analysis and decision making, Eco Pack develops packaging that marries sustainability with reduced environmental repercussions. Eco Pack's solutions are poised to replace conventional cardboard boxes and shrink-wraps prevalent in major retail chains. The closing of the agreement remains subject to the parties thereto meeting customary closing conditions and obtaining regulatory approval.
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BW | Hot Stocks06:33 EDT Babcock & Wilcox unit awarded $11M in environmental equipment contracts - Babcock & Wilcox Enterprises announced that its B&W Environmental business segment has been awarded environmental equipment contracts totaling more than $11M to supply two replacement wet electrostatic precipitators at two U.S. industrial facilities and rebuild a wet ESP for a third facility.
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FSR | Hot Stocks06:31 EDT Fisker expects to ramp deliveries to 300 vehicles per day later this year - Fisker announced that it has built 5,000 Fisker Ocean SUVs and expects to ramp deliveries of the Ocean to 300 vehicle per day later this year. To date, Fisker has delivered over 900 customer vehicles in its European and US launch markets. Several hundred more are expected to be delivered this week.
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NVS | Hot Stocks06:25 EDT Novartis' Sandoz receives European Commission approval for Tyruko - Sandoz, a Novartis division, announced that the European Commission granted marketing authorization for "the first and only biosimilar" Tyruko, developed by Polpharma Biologics. The authorization covers treatment as a single disease-modifying therapy in adults with highly active RRMS, the same indication as approved by the EC for the reference medicine Tysabri, the company stated.
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INFY MSFT | Hot Stocks06:19 EDT Infosys, Microsoft to jointly develop AI solutions - Infosys (INFY) announced that it is collaborating with Microsoft (MSFT) to jointly develop solutions that leverage Infosys Topaz, Azure OpenAI Service and Azure Cognitive Services. Both organizations are bringing together their respective artificial intelligence, or AI, capabilities in an effort to enhance enterprise functions with AI-enabled solutions across multiple industries. Through the collaboration with Microsoft, Infosys Topaz is using Azure OpenAI Service and Azure Cognitive Services to augment its capabilities, in order to help enterprise customers transition from digital to AI solutions.
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IMVT | Hot Stocks06:09 EDT Immunovant jumps 51% to $30.68 after Phase 1 IMVT-1402 results -
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SCKT | Hot Stocks06:05 EDT Socket Mobile adds upgrade option to free barcode scanner on iOS - Socket Mobile announced it is now possible to upgrade from its free SocketCam C820 to the SocketCam C860 , an enhanced camera-based barcode scanner for iOS.
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IMVT | Hot Stocks06:05 EDT Immunovant's IMVT-1402 shows Phase 1 efficacy - Immunovant announced that subcutaneously administered doses of IMVT-1402 produced dose-dependent reductions in IgG in initial data from a Phase 1 clinical trial in healthy adults, with no dose-related changes in serum albumin or LDL-C, bolstering IMVT-1402 as a potential best-in-class neonatal fragment crystallizable receptor inhibitor. In the single-ascending dose portion of the study, subcutaneously administered IMVT-1402 demonstrated a consistent reduction in IgG with potency that was similar to or greater than that of batoclimab. The safety data were generally favorable, with all adverse events (AEs) mild or moderate, and no significant reduction from baseline in serum albumin or increase in LDL-C observed at any timepoint measured. Initial MAD study results for the 300 mg cohort were released. After four weekly 300 mg SC doses of IMVT-1402, the mean total IgG reduction from baseline in this MAD cohort was 63%, with no decrease in serum albumin below baseline and no increase in LDL-C above baseline observed. Treatment-emergent adverse events were observed to be mild or moderate in severity. IMVT-1402 was delivered subcutaneously in seconds to participants in this cohort as a simple 2 mL injection at a concentration of 150 mg/mL.
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IDYA | Hot Stocks06:04 EDT Ideaya Biosciences granted Fast Track designation for IDE161 program by FDA - Ideaya Biosciences announced that the FDA has granted Fast Track designation to Ideaya's development program investigating IDE161, a potent and selective inhibitor of poly glycohydrolase, for the treatment of adult patients having advanced or metastatic ovarian cancer with germline or somatic BRCA 1/2 mutations who are platinum resistant and have received prior antiangiogenic and poly polymerase inhibitor therapies.
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KBR | Hot Stocks06:02 EDT KBR awarded blue hydrogen, FEED contract by EET Hydrogen - KBR announced that it has been awarded a blue hydrogen process technology and front-end engineering design, or FEED, contract by EET Hydrogen for its planned HPP2 low-carbon hydrogen facility at HyNet. Under the terms of the agreements, KBR will provide technology licensing, proprietary engineering design and equipment, catalyst and FEED for up to 1000 MW plant capacity to be located at the Stanlow Manufacturing Complex. HyNet includes hydrogen production and supply, and carbon capture and sequestration, or CCS, to support the decarbonization of hard-to-abate sectors in a region of concentrated conventional energy usage.
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BABA | Hot Stocks05:37 EDT Alibaba intends to spin-off Cainiao by way of separate listing - Alibaba announced that the company intends to spin-off Cainiao by way of a separate listing of the Cainiao Shares on the Main Board of the Hong Kong Stock Exchange. The company submitted a spin-off proposal to the Hong Kong Stock Exchange and the exchange has confirmed that the company may proceed with the proposed spin-off, Alibaba said in a statement. Upon completion of the spin-off, the company will continue to hold more than 50% of the shareholdings in Cainiao and therefore Cainiao will remain as a subsidiary of Alibaba.
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REGN SNY | Hot Stocks05:11 EDT Regeneron, Sanofi announce FDA acceptance for Priority Review of Dupixent sBLA - Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for Priority Review the supplemental Biologics License Application, or sBLA, for Dupixent to treat children aged one to 11 years with eosinophilic esophagitis, or EoE. The target action date for the FDA decision is January 31, 2024. Dupixent is the first and only treatment in the U.S. approved for children and adults aged 12 years and older with EoE, weighing at least 40kg. The sBLA is supported by data from the Phase 3 EoE KIDS trial evaluating the efficacy and safety of Dupixent in children aged one to 11 with EoE. In Part A, the primary endpoint was met for the proportion of patients achieving histological disease remission (defined as peak esophageal intraepithelial eosinophil count of six eosinophils [eos]/high power field [hpf]) at 16 weeks for tiered dosing regimens based on body weight, compared to placebo. Part B was an active treatment extension period evaluating Dupixent for an additional 36 weeks and showed Dupixent maintained histologic remission for 52 weeks, a secondary endpoint. Dupixent also led to increases in body weight for age percentile, which was evaluated as an exploratory endpoint in Part A and a secondary endpoint in Part B. Safety results in Parts A and B of the trial were generally consistent with the known safety profile of Dupixent in its FDA-approved EoE indication for children and adults aged 12 years and older who weigh at least 40kg. Adverse events more commonly observed with Dupixent compared to placebo were COVID-19, rash, headache, viral gastroenteritis, diarrhea and nausea. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority in this setting.
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CLVT | Hot Stocks05:07 EDT Clarivate creates Academia & Government Innovation Incubator, acquires Alethea - Clarivate announced it has established an Academia & Government Innovation Incubator. The Incubator's first program focuses on realizing better learning outcomes and student success through the acquisition of Alethea, an AI-powered students' content engagement platform created by Pangea. Alethea facilitates engagement with academic texts, class readings, and assignments through personalized and adaptive guidance.
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