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Novavax Announces Progress on Sanofi Agreement
Prnewswire· 2025-09-30 13:01
合作与许可协议修订 - 诺瓦瓦克斯与赛诺菲修订了合作与许可协议,将赛诺菲对Matrix-M佐剂的使用许可扩展至其大流行流感候选疫苗项目 [1] - 该修订允许赛诺菲在大流行流感候选疫苗的早期开发至第二阶段临床研究中使用Matrix-M佐剂 [2] - 若赛诺菲进入第三阶段临床开发,双方将就许可费率及财务条款进行协商 [2] 财务条款与里程碑 - 根据原始协议条款,诺瓦瓦克斯有资格因赛诺菲使用其Matrix-M佐剂开发的前四个产品获得高达2亿美元的款项 [3] - 对于此后每个包含Matrix-M的产品,诺瓦瓦克斯有资格获得高达2.1亿美元的里程碑付款,外加所有使用Matrix-M的赛诺菲产品的持续销售分成 [3] 战略合作与政府支持 - 赛诺菲近期获得了美国卫生与公众服务部下属机构的资金,用于支持包括使用Matrix-M佐剂在内的该候选疫苗的早期工作 [1] - 此次修订拓宽了诺瓦瓦克斯与赛诺菲的合作伙伴关系,赛诺菲目前正在探索与Matrix-M的更多合作机会 [3] 技术平台与产品管线 - Matrix-M是诺瓦瓦克斯的专利佐剂,可加入疫苗以刺激更强的免疫反应,目前用于全球已批准的疫苗 [4] - 公司的重组蛋白基纳米颗粒与其Matrix-M佐剂相结合,构成了其不断扩展的研发管线的基础 [4] - 公司的增长战略旨在优化现有合作伙伴关系,并通过研发创新、在传染病等领域的有机产品组合扩张,以及与其他公司建立新的合作伙伴关系,来扩大其成熟技术平台的可及性 [5]
MediWound announces $30M registered direct offering
Yahoo Finance· 2025-09-30 12:45
MediWound (MDWD) “announced that it has entered into a definitive securities purchase agreement led by a prominent U.S.-based mutual fund and other healthcare-focused investors for the sale and purchase of 1,734,105 ordinary shares of the Company, par value NIS 0.07 per share, at a purchase price of $17.30 per share, in a registered direct offering. The Company expects to close the offering on or about September 30, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to th ...
September 2025 Letter to Shareholders
Globenewswire· 2025-09-30 12:30
VANCOUVER, Washington, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Dear Shareholders, As this pivotal year continues to take shape for CytoDyn Inc. (“CytoDyn” or the “Company”), I am pleased to share the progress we have made in advancing leronlimab as an innovative treatment in oncology. We remain confident that addressing critical unmet needs in this field is the best way to build value while improving the lives of patients. The foundation of our conviction in leronlimab rests on both preclinical and clinical evi ...
Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access
Globenewswire· 2025-09-30 12:30
Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years US Launch of Tonmya expected in the fourth quarter of 2025 CHATHAM, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Compan ...
Energy Fuels, Firefly Aerospace And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session - bioAffinity Technologies (NASDAQ:BIAF), First Majestic Silver (NYSE:AG)
Benzinga· 2025-09-30 12:04
美股期货市场表现 - 美国股指期货走低 道指期货下跌超过100点 [1] Energy Fuels Inc (UUUU) - 公司宣布拟进行5.5亿美元2031年到期的可转换优先票据私募发行 [1] - 股价在盘前交易中下跌6.4%至15.47美元 [1] Epsium Enterprise Limited (EPSM) - 股价在盘前交易中下跌24.3%至18.60美元 此前周一已下跌30% [3] JFB Construction Holdings (JFB) - 股价在盘前交易中下跌12.9%至11.06美元 [3] - 公司此前周一宣布4400万美元私募配售后股价飙升85% [3] bioAffinity Technologies Inc (BIAF) - 股价在盘前交易中下跌11.1%至2.89美元 [3] - 公司宣布完成480万美元公开发行定价 [3] Firefly Aerospace Inc (FLY) - 股价在盘前交易中下跌9.7%至33.36美元 [3] - 公司报告其下一次任务的Alpha火箭核心级在测试事故中被毁 [3] USBC, Inc. (USBC) - 股价在盘前交易中下跌6.7%至1.26美元 此前周一大涨16% [3] Tilray Brands, Inc. (TLRY) - 股价在盘前交易中下跌5.4%至1.75美元 [3] - 公司股价周一大涨超过60% 因前总统特朗普分享讨论CBD对老年人潜在益处的视频 [3] First Majestic Silver Corp. (AG) - 股价在盘前交易中下跌4.8%至11.80美元 [3] LuxExperience B.V. (LUXE) - 股价在盘前交易中下跌4.5%至8.07美元 [3]
OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update
Newsfile· 2025-09-30 11:40
OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory UpdateSeptember 30, 2025 7:40 AM EDT | Source: OS TherapiesCompany updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting feedback from UK MHRAIn principle, UK MHRA accepts use of historical control arm to support conditional MAAUK MHRA conditional MAA and US FDA Biologics Licensing ...
New Binance Coin and Aethir Treasuries Raise Over $400M To Launch
Yahoo Finance· 2025-09-30 11:32
The DAT era is here. | Credit: Credit: Raymond Boyd/Getty Images.. Key Takeaways Digital Asset Treasuries are publicly traded firms dedicated to accumulating crypto. Aethir is a DePIN project offering GPU-as-a-service solutions for AI, gaming, and cloud. Binance Coin treasuries currently comprise over $500 million worth of BNB. Two new Digital Asset Treasuries (DATs) from two separate biotech firms are set to launch after raising a combined $402 million in private placements to acquire huge sums o ...
Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study of IBTROZI™ (taletrectinib) for the Adjuvant Treatment of ROS1-Positive Early-Stage Non-Small Cell Lung Cancer
Businesswire· 2025-09-30 11:30
NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy and safety of IBTROZIâ"¢ (taletrectinib), a next-generation ROS1 inhibitor, versus placebo for the adjuvant treatment of patients with resected ROS1-positive (ROS1+) early-stage non-small cell lung cancer (NSCLC). "While surgi. ...
Precision BioSciences Announces Late-Breaking Poster Presentation at the 30th Annual International Congress of the World Muscle Society
Businesswire· 2025-09-30 11:01
DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced a late-breaking poster presentation at the 30th Annual International Congress of the World Muscle Society (WMS) being held October 7-12, 2025, in Vienna, Austria. "We look forward to sharing the latest preclinical data for PBGENE-DMD at the upcoming. ...
BioMarin: Valuation, Growth, And The Pipeline May Outweigh TransCon Competition And Regulatory Risks
Seeking Alpha· 2025-09-30 11:01
Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in BMRN over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking ...