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Capricor Therapeutics: A Buy Ahead Of Phase 3 Topline And Clarified Regulatory Pathway
Seeking Alpha· 2025-09-29 13:08
Analyst’s Disclosure:I/we have a beneficial long position in the shares of CAPR either through stock ownership, options, or other derivatives. 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 Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any in ...
Genmab Strikes $8 Billion Deal To Acquire Cancer-Focused Merus
Investors· 2025-09-29 13:03
BREAKING: Futures Climb With Tesla Deliveries, September Payrolls On Tap Genmab (GMAB), on Monday, announced its plan to buy cancer-focused biotech company Merus (MRUS) for about $8 billion. The news sent Merus stock into the stratosphere. Merus is working on a drug called petosemtamab, which can simultaneously block two drivers of cancer. Its most advanced program is in head-and-neck cancer, but Merus is also testing the drug in patients with metastatic colorectal cancer. Petosemtamab could generate $3 bi ...
Climb Bio (NasdaqGM:CLYM) Update / Briefing Transcript
2025-09-29 13:02
Climb Bio (NasdaqGM:CLYM) Update / Briefing September 29, 2025 08:00 AM ET Company ParticipantsCarlo Tanzi - Principal & FounderAoife Brennan - President, CEO & Board MemberCraig Gordon - Nephrologist & Co-Director of Evidence ReviewEdgar Charles - Chief Medical OfficerJulian Harrison - Managing DirectorMatt Phipps - Group Head - BiotechnologyConference Call ParticipantsColleen Kusy - Senior Research Analyst - BiotechnologyThomas Smith - Senior MD & Senior Research AnalystLeland Gershell - MD & Senior Biote ...
Larimar's Nomlabofusp Increases Skin Frataxin Among Participants, Stock Down In Pre-Market
RTTNews· 2025-09-29 12:39
Larimar Therapeutics, Inc. (LRMR), Monday announced encouraging data from the ongoing long-term open label or OL study, evaluating daily subcutaneous injections of nomlabofusp in participants with Friedreich's ataxia, a rare, progressive, and systemic disease with neurologic deterioration. During the study, participants were initially administered 25 mg of nomlabofusp daily. Later, the dose was increased to 50 mg in the fourth quarter of 2024. The data showed that nomlabofusp increases skin frataxin or FXN ...
Dyne Therapeutics Receives Orphan Drug Designation in Japan for DYNE-251 in Duchenne Muscular Dystrophy
Globenewswire· 2025-09-29 12:35
- Data from ongoing DELIVER trial demonstrated sustained functional improvement through 18 months; results from Registrational Expansion Cohort expected late 2025 - WALTHAM, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company, today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted Orphan Drug designation for DYNE-251 in individuals with Duchenne muscular dystrophy (DMD) who have mutations in the DMD gene that are amen ...
Ernexa Therapeutics President & CEO Sanjeev Luther to Present on Expert Panel at 5th Annual iPSC Drug Development Summit
Globenewswire· 2025-09-29 12:30
CAMBRIDGE, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced that its President and CEO, Sanjeev Luther, will participate in a featured panel discussion at the upcoming 5th Annual iPSC Drug Development Summit on October 1 in Boston. “Participation in the iPSC Drug Development Summit provides Ernexa the opportunity to contribute to important conversations shaping the f ...
Oncolytics Biotech® Announces Update for Potential First-Line Pancreatic Cancer Registration Study
Prnewswire· 2025-09-29 12:30
核心事件 - Oncolytics Biotech公司宣布其候选药物pelareorep在一线胰腺导管腺癌的注册导向临床试验的拟议设计更新 [1] - 公司计划于2025年11月中旬与美国食品药品监督管理局会面以推进研究细节 [1] 临床试验设计 - 试验采用三臂设计:1) 吉西他滨+白蛋白紫杉醇对照组;2) 对照组+pelareorep;3) 对照组+pelareorep+检查点抑制剂 [8] - 主要终点为总生存期 [8] - 试验将具备足够的统计效力以检测研究组与对照组之间的统计学显著性 [8] - 计划进行中期疗效分析以便对潜在临床获益进行早期评估 [8] 临床数据依据 - 拟议设计基于一项事后汇总临床分析,该分析发现,在化疗基础上加用pelareorep实现了约22%的两年生存率,而历史第三方基准中仅接受化疗的患者两年生存率为9% [3] 公司战略与前景 - 公司首席执行官表示,该试验设计旨在为患者和监管机构提供有意义的数据,并有望确立pelareorep作为一线胰腺癌首个获批的免疫疗法 [4] - 公司认为该试验设计可能吸引潜在合作伙伴,并加速药物开发 [4] - pelareorep在转移性胰腺癌和乳腺癌的研发项目均已获得FDA的快速通道资格 [6] - 公司正积极寻求战略合作伙伴关系以加速开发并最大化商业影响 [6] 药物机制与研发进展 - pelareorep是一种研究性静脉给药的双链RNA免疫治疗剂,旨在通过激活先天性和适应性免疫反应,将免疫学上的“冷”肿瘤转化为“热”肿瘤 [5] - 该药物在一线胰腺癌研究、两项转移性乳腺癌的随机二期研究以及肛癌和结直肠癌的早期研究中均显示出令人鼓舞的结果 [5]
BioLineRx (NasdaqCM:BLRX) Earnings Call Presentation
2025-09-29 12:30
Driving therapeutic innovation forward Corporate Presentation September 2025 Forward-Looking Statements This presentation contains "forward-looking statements," including statements regarding expectations, beliefs, intentions or strategies for the future. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential success of our license agreements and joint venture, the commercial potential of motixafortide and GLIX1, expectations with re ...
Vivos Inc Board Authorizes Vivios Inc to Establish a Corporate Entity in India
Globenewswire· 2025-09-29 12:30
Kennewick, WA, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) The Vivos Board granted authorization to form a wholly owned corporate subsidiary in India. Vivos Inc filed for the name of Vivos Scientific India LLP. Vivos is completing the steps remaining to obtain formal approvals from the Indian government. “This demonstrates our long-term commitment to doing business in India and supports our long-term plan of establishing our first international manufacturing center for RadioGel and IsoPet, f ...
D. Boral Capital to Host KOL Webinar With World Leading Experts Featuring Insights & Breakthroughs from Enlivex's Knee Osteoarthritis Program
Globenewswire· 2025-09-29 12:15
Nes-Ziona, Israel, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, will participate in a live investor webinar, “Advancing Inflammatory Disease Treatment: Insights & Breakthroughs from Enlivex's Knee Osteoarthritis Program,” hosted by D. Boral Capital on September 30, 2025, at 10:00 AM Eastern Time. The discussion will bring together leading key opinion leaders (KOLs) in musculoskeletal disease, alon ...