Capricor Therapeutics (CAPR) shares soared 5.3% in the last trading session to close at $6.52. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 1% loss over the past four weeks.The sharp rise in CAPR shares can be attributed to the company’s encouraging regulatory update on its Deramiocel program for Duchenne muscular dystrophy. Following a Type A meeting with the FDA, the company received guidance outlining a pathway toward a pot ...

PresentationGood morning, ladies and gentlemen. Welcome to the Capricor Therapeutics DMD Program Update Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Mr. A.J. Bergmann, Capricor's Chief Financial Officer. Please go ahead.Anthony BergmannCFO & Corporate Treasurer Thank you, and good morning, everyone. Before we start, I would like to state that we will be making certain forward-looking statements during today's presentatio ...

Capricor Therapeutics (NasdaqCM:CAPR) Update / Briefing September 25, 2025 08:30 AM ET Company ParticipantsAJ Bergmann - CFOLinda Marbán - CEO & DirectorJoe Pantginis - Managing Director, Equity ResearchAydin Huseynov - Managing Director, Equity ResearchCatherine Novack - Director - HealthcareRohan Mathur - Biopharma Equity Research AssociateConference Call ParticipantsKristen Kluska - Equity Research AnalystMadison Elsaadi - Equity Research Analyst - HealthcareEdward Tenthoff - MD & Senior Research Analyst ...

FDA and Capricor aligned on endpoints for HOPE-3 pivotal trialHOPE-3 pivotal trial completed; topline data expected mid-Q4 2025 to support BLA resubmissionCompany preparing to resubmit CRL response under the current BLAConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced a regulatory update for ...

SAN DIEGO, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Johnson Fistel, PLLP is investigating potential legal claims on behalf of Capricor Therapeutics, Inc. (NASDAQ: CAPR) shareholders, concerning alleged misconduct by certain officers and directors that may have harmed the company and its investors. Investors who have continuously held Capricor shares since before October 9, 2024, may have legal rights and are encouraged to contact the firm to learn more:https://www.johnsonfistel.com/investigations/capricor-therape ...

核心观点 - 律师事务所Bragar Eagel & Squire正在调查Capricor Therapeutics可能存在的董事会违反 fiduciary duty行为 并代表长期股东提起潜在索赔 调查基于2025年7月17日提交的集体诉讼 指控公司在2024年10月9日至2025年7月10日期间向投资者提供虚假和误导性陈述 [1][2] 诉讼背景 - 集体诉讼针对Capricor Therapeutics提出 覆盖时间段为2024年10月9日至2025年7月10日 重点关注公司董事会是否违反 fiduciary duty [1] - 指控称被告向投资者提供关于 lead cell therapy candidate drug deramiocel 的重大信息 该药物用于治疗Duchenne muscular dystrophy (DMD) 相关的心肌病 同时传播虚假和误导性陈述 和/或隐瞒其 Phase 2 HOPE-2 trial study 的四年安全性和有效性数据的不利事实 [2] 监管事件 - Capricor于2025年7月11日发布新闻稿 宣布收到FDA的 Complete Response Letter (CRL) 拒绝其 Biologics License Application (BLA) 具体理由为未满足 substantial evidence of effectiveness 的法定要求 且需要 additional clinical data CRL还提到 Chemistry, Manufacturing, and Controls section 的 outstanding items [3] 市场影响 - 在2025年7月11日新闻发布后 Capricor股价从2025年7月10日的每股11.40美元下跌至2025年7月11日的每股7.64美元 跌幅显著 [4] 公司产品 - Capricor的 lead cell therapy candidate drug deramiocel 针对Duchenne muscular dystrophy (DMD) 相关的心肌病治疗 其 Phase 2 HOPE-2 trial study 生成四年安全性和有效性数据 [2]

NEW YORK--(BUSINESS WIRE)---- $CAPR #Capricor--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Capricor Therapeutics, Inc. ("Capricor†or the "Company†) (NASDAQ: CAPR) and reminds investors of the September 15, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Geor ...

核心事件 - 律师事务所代表在2024年10月9日至2025年7月10日期间购买Capricor Therapeutics股票的投资者提起集体诉讼 [2] - 指控公司就治疗杜氏肌营养不良心肌病的主要细胞疗法药物deramiocel向投资者提供重大虚假信息 [2] - 公司声称能够获得FDA生物制剂许可申请 但被指控隐瞒HOPE-2试验四年安全性和有效性数据的不利事实 [2] 监管进展 - 2025年7月11日FDA发出完整回复函 拒绝生物制剂许可申请 [2] - 监管机构指出缺乏有效性实质证据 需要额外临床数据 [2] - 申请文件中化学制造与控制部分存在未解决问题 [2] 市场反应 - 监管拒绝导致股价从2025年7月10日的11.40美元/股暴跌至7月11日的7.64美元/股 单日跌幅达33% [2] - 股价下跌造成投资者重大损失 引发证券集体诉讼 [2][3] 法律程序 - 投资者登记截止日期为2025年9月15日 [3] - 参与投资者将获得案件生命周期内的投资组合监控服务 [3] - 律师事务所专注于保护因欺骗、欺诈和非法商业行为而受损的投资者权利 [4]

NEW YORK, Sept. 14, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Capricor Therapeutics, Inc. (NASDAQ: CAPR) between October 9, 2024 and July 10, 2025, both dates inclusive (the “Class Period”), of the important September 15, 2025 lead plaintiff deadline. SO WHAT: If you purchased Capricor securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee a ...

诉讼背景 - 罗森律师事务所提醒在2024年10月9日至2025年7月10日期间购买Capricor Therapeutics Inc（NASDAQ: CAPR）证券的投资者注意2025年9月15日的首席原告截止日期 [1] 诉讼性质 - 针对Capricor Therapeutics的集体诉讼已提起 指控公司在整个集体诉讼期间向投资者提供有关其领先细胞疗法候选药物deramiocel的重要信息 同时传播虚假和误导性陈述和/或隐瞒其Phase 2 HOPE-2试验研究的四年安全性和有效性数据的重要不利事实 [5] - 据称这导致股东以人为抬高的价格购买Capricor证券 当真实细节进入市场时 投资者遭受了损失 [5] 公司产品细节 - Capricor的主要细胞疗法候选药物deramiocel用于治疗杜氏肌营养不良症（DMD）相关的心肌病 [5] - 公司的陈述包括其从美国食品和药物管理局（FDA）获得deramiocel生物制剂许可申请（BLA）的能力 [5] 律师事务所信息 - 罗森律师事务所专门从事证券集体诉讼和股东派生诉讼 在2017年被ISS证券集体诉讼服务评为证券集体诉讼和解数量第一 自2013年以来每年都排名前四 [4] - 该事务所已为投资者追回数亿美元 仅在2019年就为投资者确保了超过4.38亿美元 [4] - 2019年该事务所为中国公司达成了当时最大的证券集体诉讼和解 [4]