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Capricor: Post-CRL Path To DMD Cardiomyopathy Approval In 2026
Seeking Alpha· 2025-09-29 19:51
I have a strong inclination towards high-growth companies, often treading in sectors poised for exponential expansion. My expertise lies in understanding and investing in disruptive technologies and forward-thinking enterprises. My approach is a mix of fundamental analysis and future trend prediction. I believe in the power of innovation to yield substantial returns and aim to provide insightful analysis on such companies here on SeekingAlpha.Analyst’s Disclosure:I/we have no stock, option or similar deriva ...
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 ...
Capricor (CAPR) Surges 5.3%: Is This an Indication of Further Gains?
ZACKS· 2025-09-26 11:46
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 ...
Capricor Therapeutics, Inc. - Special Call
Seeking Alpha· 2025-09-25 15:07
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 Transcript
2025-09-25 13:32
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 ...
Capricor Therapeutics Provides Regulatory Update on Deramiocel Program for Duchenne Muscular Dystrophy Following Type A Meeting
Globenewswire· 2025-09-25 11:15
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 ...
Capricor Therapeutics, Inc. Long-Term Shareholder Announcement: Johnson Fistel Encourages Investors to Reach Out For More Information About Continuing Investigation
Globenewswire· 2025-09-23 13:45
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 ...
CAPRICOR ALERT: Bragar Eagel & Squire, P.C. is Investigating Capricor Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
Globenewswire· 2025-09-16 21:13
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]
FINAL DEADLINE ALERT: Faruqi & Faruqi Reminds Capricor Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of September 15, 2025 - CAPR
Businesswire· 2025-09-15 15:45
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 ...
Capricor Therapeutics, Inc. Sued for Securities Law Violations - Contact The Gross Law Firm Before September 15, 2025 to Discuss Your Rights - CAPR
Prnewswire· 2025-09-15 12:45
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]