NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of PepGen Inc. (NASDAQ: PEPG). Shareholders who purchased shares of PEPG during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/pepgen-inc-loss-submission-form/?id=157194&from=3 CLASS PERIOD: March 7, 2024 to March ...

NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Capricor Therapeutics, Inc. (NASDAQ: CAPR). Shareholders who purchased shares of CAPR during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/capricor-loss-submission-form/?id=157205&from=3 CLASS PERIOD: October ...

NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Biohaven Ltd. (NYSE: BHVN). Shareholders who purchased shares of BHVN during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/biohaven-ltd-loss-submission-form/?id=157193&from=3 CLASS PERIOD: March 24, 2023 to Ma ...

NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Sarepta Therapeutics, Inc. (NASDAQ: SRPT). Shareholders who purchased shares of SRPT during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/sarepta-loss-submission-form/?id=157188&from=3 CLASS PERIOD: June 22, 2 ...

PHILADELPHIA, July 21, 2025 /PRNewswire/ -- Berger Montague PC, a leading Philadelphia-based law firm representing investors, announces that a securities class action lawsuit has been filed against Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket Pharmaceuticals" or the "Company") on behalf of investors who suffered losses due to alleged material misstatements and omissions.If you purchased Rocket Pharmaceuticals stock during the period from September 17, 2024 to May 26, 2025 (the "Class Period"), you m ...

CARLSBAD, Calif., July 21, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that company management will participate in a virtual fireside chat as part of the UBS Biotech Management Live Call Series on July 25, 2025. Details of the event are below: Title: "Fireside Chat on Achondroplasia and Growth Dis ...

NEW YORK, July 21, 2025 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of Biohaven Ltd. (NYSE: BHVN) between March 24, 2023 and May 14, 2025, both dates inclusive (the "Class Period"). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 12, 2025.So What: If you purchased Biohaven securities during the Class Period you may ...

NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- Class Action Attorney Juan Monteverde with Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report. The firm is headquartered at the Empire State Building in New York City and is investigating iTeos Therapeutics, Inc. (NASDAQ: ITOS) related to its sale to Concentra Biosciences, LLC. Under the terms of the proposed transact ...

监管行动 - 美国FDA对Sarepta Therapeutics的肢带型肌营养不良症(LGMD)基因疗法临床试验实施临床暂停 原因是存在严重安全隐患 包括3例可能与产品相关的患者死亡 显示参与者面临不合理且重大的疾病或伤害风险[1] - FDA正式要求公司自愿停止已获批基因疗法Elevidys的所有发货 但公司拒绝了这一请求[2] 分析师观点 - Needham将Sarepta评级从持有下调至表现不佳 认为FDA的反馈使Elevidys的未来存疑 预计FDA可能采取正式行动限制该药物营销 并担忧公司可能难以履行2027年债务义务[3] - Needham分析师指出 FDA生物制品评价与研究中心现任主任Vinay Prasad曾公开批评Elevidys的获批 前主任Peter Marks也支持这一立场 为可能撤市提供了政治支持 认为针对公司的重大监管行动可能性很高[4] - William Blair认为FDA的公告对公司是最坏情况 可能影响患者对Elevidys的兴趣 并暗示公司与FDA关系破裂 药物正式撤市威胁可能重新引发对公司长期债务义务的讨论[5] 市场反应 - Sarepta Therapeutics股价周一收盘下跌3 98%至13 52美元[6] - 多家机构下调评级和目标价：Mizuho从跑赢大盘下调至中性 目标价从40美元降至14美元 Piper Sandler维持中性评级但目标价从32美元降至18美元 BMO Capital维持市场表现评级但目标价从70美元降至50美元 Leerink Swann从跑赢大盘下调至市场表现 目标价从45美元大幅降至10美元[7] 业务影响 - William Blair预计Elevidys不会正式撤市 但更新模型反映了SRP-9003的生物制剂许可申请提交延迟 以及Elevidys在可走动患者群体中商业采用率降低[6]

核心观点 - Mesoblast Ltd的股价因FDA批准的Ryoncil®商业化成功而大幅上涨38% [1] - Ryoncil®是首个且唯一获FDA批准用于儿童SR-aGvHD的间充质基质细胞(MSC)产品 [2] - 公司拥有7年孤儿药独占权和生物制品独占权至2036年 [4] - 公司计划将Ryoncil®适应症扩展至成人SR-aGvHD [7] 财务表现 - 第一季度Ryoncil®实现总收入1320万美元 [1] - 公司现金储备达1.62亿美元(2.47亿澳元) [3] - 从日本TEMCELL® HS Inj销售中获得160万美元特许权使用费 [3] 产品进展 - Ryoncil®已覆盖超过250万美国患者 [6] - 已完成25个移植中心入驻 计划本季度完成45个优先中心 [6] - 第二代MSC疗法rexlemestrocel-L正在开发中 用于慢性炎症疾病 [8] 市场反应 - 股价周涨幅达35%至2.41美元 但本周回落3.7%至2.32澳元 [2][9] - 投资者情绪有所缓和 但长期前景仍被看好 [9] 未来发展 - 正在与FDA讨论Ryoncil®用于成人SR-aGvHD的关键试验 [7] - rexlemestrocel-L可能通过RMAT资格获得加速批准 [8] - 市场将持续关注产品推广和临床试验进展 [10]