Stockwinners Market Radar for December 28, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:53 EST Four Corners Property Trust acquires Burger King property for $1.7M - Four Corners Property Trust is pleased to announce the acquisition of a Burger King property for $1.7M. The property is located in a strong retail corridor in Virginia and under a corporate long-term, triple net lease with approximately 13 years of term remaining. The transaction was priced at a 7.0% cap rate on rent as of the closing date and exclusive of transaction costs. Including this acquisition, FCPT completed real estate acquisitions of 87 properties in 2024 for a total investment of approximately $265M, exclusive of transaction costs.

17:04 EST Ascend Wellness announces share buyback program - Ascend Wellness announced it has received authorization from the company's board of directors to commence a share buyback program. Pursuant to a normal course issuer bid, or NCIB, commencing on January 2, 2025, the company may repurchase up to the lesser of: 10,215,690 shares of the company's class A common stock, representing approximately 5% of AWH's outstanding common shares; and $2.25M worth of common shares, in the open market. As of December 24, there were a total of 204,313,808 issued and outstanding common shares.

16:08 EST Vincerx Pharma enters binding term sheet for merger with Oqory - Vincerx Pharma announced that it has entered into a binding term sheet for a proposed merger with Oqory, a privately-held, clinical-stage company developing ADCs for the treatment of multiple oncology indications. Upon completion of the proposed merger, Oqory, Inc. will merge with Vincerx Pharma, Inc. Post-closing, Oqory equity holders are expected to own approximately 95% of the combined entity, while Vincerx equity holders will hold about 5%. The transaction includes a minimum fully diluted equity value of $13.66M for existing Vincerx stockholders at closing and, as a condition to the closing of the merger, completion of a concurrent offering of Vincerx equity securities of at least $20M. Additionally, Oqory-designated investors will provide interim financing to Vincerx of $1.5M in two tranches, approximately $1,000,000 of which was funded today through the issuance of common stock and pre-funded warrants along with accompanying common stock warrants and approximately $500,000 of which will be funded on or prior to January 31, 2025. The merger is subject to customary closing conditions, including due diligence, regulatory approvals, negotiation of a definitive merger agreement, stockholder approval from both parties, completion of the minimum $20M financing, and the continued listing of Vincerx's common stock on Nasdaq. Vincerx is also implementing additional streamlining and cost-control measures, including a workforce reduction, as it pursues due diligence and transaction-related work. As part of this workforce reduction, Dr. Ahmed Hamdy, Chairman and CEO, has stepped down as CEO but will remain as Chairman. Dr. Raquel Izumi has stepped down as President and COO and taken over as Acting CEO in a consulting capacity. Alexander Seelenberger has stepped down as CFO, and Kevin Hass, the company's Vice President and Controller, has taken over as Acting CFO. Seelenberger has agreed to provide ongoing assistance in a consulting capacity to assist the company as it pursues its strategic efforts.

15:43 EST Ollie's Bargain Outlet down 2% in late trading - Weakness in shares of bargain store chain Ollie's (OLLI) may be related to Big Lots (BIG) having announced that it has agreed to a sale transaction with Gordon Brothers Retail Partners that enables the transfer of Big Lots assets, including stores, distribution centers, and intellectual property, to other retailers and companies, including Variety Wholesalers.

14:23 EST JBS S.A., Marfrig slip after China launches probe of beef imports - Shares of JBS SA (JBSAY), Marfrig (MRRTY), and other Brazilian beef producers slumped following news that China is launching a probe into its beef imports at the request of China's domestic industry associations. China's Ministry of Commerce said Friday that it will decide if a surge in shipments from overseas has hurt the domestic beef industry, according to Bloomberg. The investigation is likely to end within eight months, but may be extended under special circumstances, according Bloomberg, citing a statement on the ministry's website. Reference Link

13:26 EST Intchains Group Ltd (ADR) trading resumes

13:02 EST Baker Hughes reports U.S. rig count unchanged at 589 rigs - Baker Hughes reports the U.S. rig count is unchanged from last week at 589, with oil rigs unchanged at 483, gas rigs unchanged at 102 and miscellaneous rigs unchanged at 4. The U.S. rig count is down 33 rigs from last year's count of 622, with oil rigs down 17, gas rigs down 18 and miscellaneous up 2. The U.S. offshore rig count is unchanged at 14, down 6 year-over-year.

12:00 EST MultiPlan rises 17.7% - MultiPlan is up 17.7%, or $2.22 to $14.78.

12:00 EST Cango falls -10.0% - Cango is down -10.0%, or -52c to $4.68.

12:00 EST Bakkt falls -10.5% - Bakkt is down -10.5%, or -$3.19 to $27.22.

11:32 EST Siyata Mobile Inc trading resumes

10:25 EST Arqit Quantum trading resumes

10:21 EST Scotiabank completes minority investment in KeyCorp - KeyCorp (KEY) announced that The Bank of Nova Scotia (BNS) has completed its purchase of KeyCorp's common stock with an investment of approximately $2B, as expected. With this investment, Scotiabank now owns approximately 14.9% of KeyCorp's common stock. The parties received Federal Reserve approval for the transaction on December 12, 2024. This purchase completes Scotiabank's strategic minority investment in KeyCorp pursuant to the agreement announced on August 12, 2024.

10:16 EST HomesToLife Ltd trading halted, volatility trading pause

10:07 EST Sealsq Corp trading resumes

10:03 EST Traws Pharma Inc trading halted, volatility trading pause

10:00 EST Oklo falls -6.2% - Oklo is down -6.2%, or -$1.49 to $22.55.

10:00 EST Four Seasons Education falls -10.1% - Four Seasons Education is down -10.1%, or -$1.01 to $9.00.

10:00 EST Surf Air Mobility rises 7.7% - Surf Air Mobility is up 7.7%, or 42c to $5.91.

09:56 EST EHang partners with China Communications Information & Technology Group - EHang Holdings announced a comprehensive strategic partnership with China Communications Information & Technology Group in the fields of the low-altitude economy and advanced air mobility ecosystem. CCIT is a specialized subsidiary of China Communications Construction Group. As part of the collaboration, CCIT will work with various business sectors under CCCG, including China Communications Construction, to partner with EHang to co-develop digital UAM infrastructure and transportation hubs, innovate UAV services, as well as establish a commercial operation model and comprehensive support system for the low-altitude economy. Through this strategic partnership, EHang and CCIT will collaborate on advancing the research and development, planning and construction of digital UAM infrastructure, while also promoting integrated innovations of the low-altitude economy industry. The two parties will combine their respective technological expertise and industrial experience to incorporate digital technologies such as 5G, 6G, satellite communications, sensing, and high-precision navigation into the low-altitude aviation industry. These initiatives target creating an intelligent low-altitude platform that integrates five key networks: air traffic infrastructure network, aerial route network, communications and navigation network, airspace management network, and low-altitude service network.

09:48 EST Zeekr falls -5.5% - Zeekr is down -5.5%, or -$1.78 to $30.52.

09:48 EST Vertical Aerospace rises 5.0% - Vertical Aerospace is up 5.0%, or 59c to $12.32.

09:47 EST Surf Air Mobility rises 10.8% - Surf Air Mobility is up 10.8%, or 59c to $6.08.

09:41 EST BGM Group completes acquisition of intelligent platform from AIX - BGM Group announced completion of the acquisition of the intelligent platform of AIX. It marks BGM's official entry into the domains of AI intelligent technology and financial/insurance services, opening up new opportunities for the integrated development of healthcare, pharmaceuticals, and insurance on a global scale. Through the acquisition of RONS Technology and Xinbao Investment, BGM will be able to integrate resources in intelligent technology and biopharmaceuticals, strengthening its market competitiveness at the intersection of healthcare technology and insurance technology. This will enable the Company to offer more comprehensive and intelligent health and insurance service solutions to users, while simultaneously pioneering the synergistic development of 'healthcare, pharmaceuticals, and insurance' on a global scale, further enhancing its global influence.

09:40 EST Palladyne AI Corp trading halted, volatility trading pause

09:33 EST BioNTech to pay $791.5M in settlement agreement with the NIH - In a regulatory filing, BioNTech (BNTX) said, "BioNTech previously disclosed that it was in discussions with the National Institutes of Health concerning royalties and other related amounts allegedly owed on sales of the Company's, and its collaboration partner, Pfizer's (PFE) COVID-19 vaccine since commercialization. On December 20, 2024, the Company entered into a settlement agreement with the NIH. Under the terms of the Settlement Agreement, the Company will, among other things, pay $791.5M, consisting of $750M as a settlement for claimed royalties during calendar years 2020-2023 and $41.5M in consideration for the NIH's entry into an Amended and Restated License Agreement, dated December 20, 2024 to the NIH within 60 days of December 20, 2024. The Company's execution of the Settlement Agreement does not in any way constitute an admission of liability with respect to any allegation raised by the NIH, all of which the Company expressly denies, and nothing in the Settlement Agreement shall be taken as or construed to be an admission by the Company as evidence supporting any such allegation, any matter of fact or law, any violation of law or any other liability whatsoever. Upon the receipt of the Settlement Payment, the NIH has agreed to consider any alleged noncompliance under the Amended License Agreement to be resolved for the period up to and including January 1, 2024, including any claimed historical royalty payments allegedly owed by the Company prior to January 1, 2024, and agreed to withdraw the notice of default previously issued to the Company in connection with such alleged noncompliance. Concurrent with entry into the Settlement Agreement, the Company and the NIH entered into the Amended License Agreement, pursuant to which the Company and the NIH agreed that the Company's amended royalty obligation on Net Sales of Licensed Products will be an amount of up to a low single-digit percentage on Net Sales of Licensed Products, effective as of January 1, 2024, and which provides a framework for a license for use in combination products, which would include the COVID-19 vaccine used in combination with other active pharmaceutical ingredients. In connection with the Settlement Agreement, Pfizer has agreed to reimburse the Company for $364.5M of the claimed royalties paid to the NIH for 2020-2023 sales under the Settlement Agreement."

09:26 EST Nutriband extends Chinese patent to Macao for AVERSA technology - Nutriband has completed the registration requirements to extend its Chinese patent to Macao for its patent entitled, "Abuse and Misuse Deterrent Transdermal Systems," which protects its AVERSA abuse deterrent transdermal technology. The Macao IP Office has assigned number J/9010 to the patent with an entry date of December 17, 2024. Macao is a Special Administrative Region of the People's Republic of China which affords it a high degree of autonomy with its own patent system and patent laws which are separate and distinct from those of mainland China. The Aversa abuse deterrent technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia as well as two regions of China: Hong Kong and Macao.

09:06 EST Safe and Green Development provides timelines for JV development portfolio - Safe and Green Development is excited to share its expected timeline for completion of its joint venture developments in Southern Texas. The timeline below is only considering the existing portfolio of joint ventures; however, the company will look to continue to expand its portfolio of joint ventures and initiate development on its existing joint venture properties in Oklahoma and Georgia. 2025: The company expects to complete all 35 homes in the Sugar Developments throughout 2025. Additionally, the sitework for the 57 lots at Hacienda Olivia Phase II will be completed in the first quarter of 2025. The company then expects to build the first 20 homes of that development throughout the rest of the year. The goal for homes delivered in 2025 will be approximately 55 homes. In Q1 2025, the company will begin the sitework for Hacienda Olivia Phase IV for a total of approximately 113 lots with completion of the sitework expected in early 2026. 2026: The company expects to complete the remaining 37 homes from the Hacienda Olivia Phase II development throughout 2026. SGD expects to deliver 35 homes from the Hacienda Olivia Phase IV development throughout the year. The goal for homes delivered in 2026 is approximately 72 homes. Like the previous year, the company will begin sitework on Hacienda Olivia Phase III for 77 lots in Q1 of 2026. 2027: The company expects to complete the remaining 78 homes from the Hacienda Olivia Phase IV development throughout 2027. The company will also look to deliver 22 homes from the Hacienda Olivia Phase III development throughout the year. The goal for homes delivered in 2027 is approximately 100 homes.

09:02 EST Arthur J. Gallagher acquires BMR Insurance, terms not disclosed - Arthur J. Gallagher & Co. announced the acquisition of Tustin, California-based Murray Gardner Insurance Agency Inc., dba BMR Insurance. Terms of the transaction were not disclosed. BMR Insurance is a retail insurance agency serving commercial and personal lines clients primarily across Southern California.

09:02 EST CBAK Energy Technology announces $30M-$35M in orders from Anker Innovations - CBAK Energy Technology announced that its wholly-owned subsidiary, Nanjing CBAK New Energy Technology Co., has secured substantial orders from Anker Innovations Technology Co., one of the Chinese global intelligent hardware brand enterprises with the largest revenue scale. The company has received orders in 2024 with a total value of approximately $30M-$35M.

08:58 EST Executive chairman David Schlanger buys 150K shares of Progyny common stock - In a regulatory filing, Progyny disclosed that executive chairman David Schlanger bought 150K shares of Progyny common stock on December 26 at $14.68 per share. Following the release of the filing, in pre-market trading, shares of Progyny are higher by 5.4% to $15.50.

08:46 EST BTCS announces decision to sunset StakeSeeker Platform - BTCS announced its decision to sunset its StakeSeeker platform. This strategic shift will enable the company to concentrate its resources on scaling its Ethereum blockchain infrastructure operations, which remain the primary driver of revenue and core to its long-term vision. BTCS's StakeSeeker platform has provided crypto asset holders with monitoring and analysis tools for managing their portfolios and staking activities. Despite this, the Company has identified its blockchain infrastructure operations, particularly those related to Ethereum, as the most promising area to create sustainable value for shareholders. Importantly, this decision does not affect BTCS's ability to support crypto asset holders who choose to delegate their crypto holdings to the Company's validator nodes. Delegators will still have access to BTCS's infrastructure to earn staking rewards, further reinforcing the Company's mission to deliver scalable blockchain services. With the resources freed by sunsetting StakeSeeker, BTCS intends to enhance its validator nodes, strengthen its Builder+ Ethereum block-building operations, and expand its leadership in the proof-of-stake ecosystem.

08:36 EST Ondas regains full Nasdaq compliance - Ondas Holdings has received a notification letter from Nasdaq Stock Market confirming that it has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). To regain compliance with the Rule, the Company's common stock was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, which was achieved on December 24, 2024. Therefore, the Nasdaq Listing Qualifications Staff considers the prior bid price deficiency matter now closed. Ondas is now in full compliance with all Nasdaq continued listing requirements and will continue to be listed and traded on The Nasdaq Capital Market.

08:35 EST Safe & Green secures 'favorable' legal judgement against EDI International - Safe & Green Holdings announced a decisive legal victory in its litigation against EDI International, PC, and PVE. The Superior Court of Los Angeles County awarded a judgment in favor of Safe & Green Holdings, granting the Company $1,274,752 in damages, with additional potential awards for interest, legal costs, and attorney's fees. This judgment resolves claims related to intentional interference with prospective economic relations and contractual obligations, highlighting the Company's steadfast commitment to protecting its interests and ensuring fairness for its shareholders. Paul Galvin, Chairman and CEO, stated, "This judgment is a testament to the power of perseverance and the pursuit of justice. In the end, the truth prevailed, and we achieved a great outcome for our shareholders. This victory not only validates our position but also reinforces the strength of our team and our dedication to delivering value for those who place their trust in us."

08:34 EST LM Funding orders 270 Bitmain S21+ mining machines - LM Funding America announced a new order with Bitmain for 270 Bitmain S21+ mining machines. Bruce M. Rodgers, Chairman and CEO of LM Funding commented, "These new miners will be received in March 2025 and will be placed at our new 15MW Oklahoma Mining site. We anticipate that this will increase our total mining capacity by approximately 58 petahash. After we move our existing machines from storage into open slots at the Oklahoma mining site, we expect that our total active hashrate in January 2025 will increase to 562 petahash between our mining capacity at our owned site in Oklahoma and our mining capacity hosted with Core."

08:31 EST Tantech Holdings' Gohomeway Group signs $5M sales contract - Tantech Holdings announced that, on December 26, its U.S. subsidiary, Gohomeway Group, signed an annual purchase agreement with Heidi Enterprise Group for the period of January 2025 to December 2025. Under the terms of the agreement, Heidi Enterprise Group will procure flooring products worth $400,000 to $500,000 monthly, totaling $5M annually, from Gohomeway Group.

08:18 EST HomeStreet to sell $990M in commercial real estate loans to Bank of America - HomeStreet (HMST) announced that the bank entered into an agreement to sell to Bank of America (BAC), on a servicing retained basis, $990M of multifamily commercial real estate loans, at a price, including the value of the retained servicing, of 92% of the principal balance of the loans. This loan sale is expected to close before December 31.

08:16 EST Coeptis Therapeutics announces 1-for-20 reverse stock split - Coeptis Therapeutics announced it will proceed with a 1-for-20 reverse stock split of its issued and outstanding shares of common stock, following authorization by its board of directors and majority stockholders to effect a reverse stock split by a ratio of not less than 1-for-3 and not more than 1-for-40, with the Board having the discretion as to whether or not the Reverse Split is to be effected, and the exact ratio to be set at a whole number within the Reverse Split Range. The first day of trading on a post-split basis on the Nasdaq Capital Market, will be at market open on December 31.

08:09 EST Outlook Therapeutics provides ONS-5010/LYTENAVA update - In May 2024, the European Commission granted Marketing Authorization for LYTENAVA for the treatment of wet AMD in the EU. Additionally, in July 2024, the UK Medicines and Healthcare products Regulatory Agency granted Marketing Authorization for LYTENAVA for the same indication in the UK. In December 2024, the National Institute for Health and Care Excellence recommended LYTENAVA as an option for the treatment of wet AMD. Plans for a potential 2025 launch in the UK and Germany are ongoing. Outlook Therapeutics remains confident that ONS-5010/ LYTENAVA is an important therapy for the treatment of wet AMD in place of off-label repackaged bevacizumab that has not received regulatory approval for use in retina diseases such as wet AMD. Previously, the Company reported that in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment with the U.S. Food and Drug Administration. However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010. Analysis of the data is ongoing as the month 3 data from NORSE EIGHT is being collected, which is expected to be available in January 2025. Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025. LYTENAVA is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK and has an initial 10 years of market exclusivity. Authorization may also be sought in other European countries, Japan, and elsewhere. As part of a multi-year planning process, Outlook Therapeutics entered into a strategic collaboration with Cencora to support the commercial launch of LYTENAVA globally following regulatory approvals. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA to benefit all stakeholders, including retina specialists, providers and patients. In the EU and the UK and other regions outside of the US, Outlook Therapeutics is planning to commercialize LYTENAVA directly and is also assessing potential licensing and partnering options. Additionally, if approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA directly in the US

08:05 EST Bullfrog AI CEO: 2025 focus will remain on AI-driven solution commercialization - BullFrog AI Holdings issued a letter to stockholders from its CEO Vin Singh, which read in part, "In thinking back on this past year, it is evident that 2024 was a year of significant progress for BullFrog AI. It was a year of major advancements, strategic collaborations, and impactful discoveries, all of which have set the stage for what promises to be an even more exciting 2025. Our efforts have solidly positioned us for growth in AI-driven drug discovery, while also expanding our capabilities to address both current and emerging challenges in the pharmaceutical landscape. Key Highlights: Continued to Innovate and Advance our AI Capabilities: We significantly advanced our proprietary bfLEAP platform by integrating novel generative and causal AI technologies with graph analytics, exclusively licensed from Johns Hopkins University's Applied Physics Laboratory. This transformative enhancement enables us to generate explainable and reproducible AI results that deepen our understanding of biological mechanisms and disease drivers. The platform's expanded capabilities now support multiple critical applications in drug development, including novel drug target discovery, biomarker prediction, drug repositioning, and analysis of cellular behavior mechanisms. Achieved Key Milestones with the Lieber Institute for Brain Development: Our strategic collaboration with LIBD has yielded groundbreaking insights into neuropsychiatric disorders. Utilizing our proprietary bfLEAP platform, we identified novel biological drug targets within disorders like schizophrenia, bipolar disorder, and major depressive disorder. These insights are driving advanced discussions with several major pharmaceutical companies, setting the stage for what we believe will be material commercial agreements in 2025. This collaboration underscores the power of AI in unlocking new therapeutic pathways and has the potential to transform how these complex conditions are treated. Expansion of BF-114 Research: Building on our preclinical studies, BF-114 demonstrated compelling potential in treating obesity and related liver diseases such as metabolic-associated steatotic liver disease and hepatocellular carcinoma. The publication of new findings in Cell Reports has further validated its therapeutic promise, and we have bolstered our efforts with the addition of globally recognized expert Dr. Lopa Mishra to our Scientific Advisory Board. BF-114 continues to attract significant interest and positions us for strategic partnerships in the liver disease market, projected to exceed $36.5B by 2030. Strengthened Intellectual Property Portfolio: We achieved additional patent protections for BF-223, a promising oncology drug candidate. The issuance of an Australian patent and the continued development of BF-223 in glioblastoma enhance the value of this asset, furthering our strategy to monetize its potential through collaborations...Robust Cash Position: We successfully closed two equity offerings in 2024, raising a combined $8.83M to support growth initiatives and working capital. This prudent financial management ensures that we remain well-positioned to execute our strategic objectives. As we move into 2025, our focus will remain on driving value through innovation, strategic collaborations, and the commercialization of our AI-driven solutions, including initiatives to expand our market reach and leverage our AI capabilities to serve a broader audience. With our lean operating model and a strong pipeline of opportunities, we believe BullFrog AI is uniquely positioned to capitalize on the growing demand for AI-enabled drug development."

07:49 EST Arena Group says compliance plan with NYSE American listing standards accepted - The Arena Group announced it was notified by NYSE American that the company's plan to regain compliance with NYSE American's continued listing standards had been accepted. "The company intends to regain compliance within the prescribed plan period. The company's receipt of the notification from NYSE American accepting the compliance plan has no immediate effect on the listing or trading of the company's common stock on the NYSE American, nor does it affect the company's business operations or its reporting requirements with the U.S. Securities and Exchange Commission," Arena Group stated.

07:03 EST XCHG's GridLink achieves UL 1973, UL 9540A certifications - XCHG announced that its GridLink system has received certifications in the United States, including UL 1973 and UL 9540A. These certifications represent the benchmarks for safety, efficiency, and grid compliance, reinforcing GridLink's position in the energy storage market.

07:01 EST Cara Therapeutics announces effective date of 1-for-12 reverse stock split - Cara Therapeutics announced that a 1-for-12 reverse stock split of its outstanding shares of common stock and reduction in the total number of authorized shares of its common stock from 200,000,000 to 16,666,667 will be effective as of 5:00 p.m. Eastern Time on Monday, December 30, 2024. The Company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on Tuesday, December 31, 2024. Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "CARA" with the new CUSIP number, 140755 208. The reverse stock split is part of the Company's plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. At the effective time of the reverse split, every 12 issued and outstanding shares of the Company's common stock will automatically be combined into one issued and outstanding share of the Company's common stock without any change in the par value per share and the authorized shares of the Company's common stock will reduce from 200,000,000 to 16,666,667.

06:46 EST Surf Air Mobility board members purchase company stock - Surf Air Mobility announced that Chairman of the Board, Carl Albert, and Co-Founder and Member of the Board, Sudhin Shahani, purchased 14,500 shares and 17,237 shares, respectively, of the company's common stock, for an aggregate purchase price of approximately $110,000, in open market transactions.

06:02 EST BeiGene announces FDA approval of Tevimbra - BeiGene, a global oncology company that intends to change its name to BeOne Medicines, announced the U.S. FDA has approved Tevimbra in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1. Tevimbra is also approved in the U.S. as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-1 inhibitor. An additional Biologics License Application is under review at the FDA for the first-line treatment of adult patients with locally advanced unresectable or metastatic ESCC.

05:04 EST Argenx announces Japan MHLW approval for Vyvdura for CIDP - Argenx announced that Japan's Ministry of Health, Labour and Welfare, or MHLW, approved Vyvdura for adults with chronic inflammatory demyelinating polyneuropathy. Vyvdura is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection, which can be self-administered at home, and is the first and only neonatal Fc receptor blocker approved for the treatment of CIDP.