智通财经APP获悉，周三，部分生物制药公司股价飙升，截至发稿，Replimune(REPL.US)飙升逾85%， Sarepta Therapeutics (SRPT.US)上涨超16%，Capricor Therapeutics(CAPR.US)大涨超18%。消息面上，美 国FDA生物制品评估与研究中心主任普拉萨德在上任不到三个月后离职，正值FDA对多款基因疗法和疫 苗采取严格监管措施，引发市场关注。分析人士指出，他的离任可能有助于缓解监管压力，被视为基因 疗法和疫苗企业的利好消息。 ...

Core Viewpoint - Capricor Therapeutics, Inc. is facing a federal securities class action due to allegations of misleading statements regarding its lead drug candidate, deramiocel, and its failure to disclose material adverse facts related to its clinical trial data [3][4]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating potential claims against Capricor and has set a deadline of September 15, 2025, for investors to seek the role of lead plaintiff in the class action [1][3]. - The complaint alleges that Capricor and its executives violated federal securities laws by making false statements about the drug deramiocel and its FDA approval process [3]. Group 2: Drug Development and Regulatory Issues - Capricor's lead drug candidate, deramiocel, is intended for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [3]. - On July 11, 2025, Capricor received a Complete Response Letter (CRL) from the FDA, denying the Biologics License Application (BLA) due to insufficient evidence of effectiveness and the need for additional clinical data [4]. Group 3: Stock Market Reaction - Following the announcement of the CRL, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025, indicating a significant market reaction to the news [5].

CAPR investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Capricor investors who were adversely affected by alleged securities fraud between October 9, 2024 and July 10, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/capricor-therapeutics-inc-lawsuit-submission-form-2?prid=158418&wire=4 NEW YORK, July 29, 2025 / ...

Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action securities lawsuit due to alleged securities fraud related to its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][2] Group 1: Lawsuit Details - The lawsuit aims to recover losses for investors affected by alleged fraud between October 9, 2024, and July 10, 2025 [1] - Defendants allegedly provided misleading information regarding Capricor's ability to obtain a Biologics License Application (BLA) from the FDA while concealing adverse facts about the safety and efficacy data from the Phase 2 HOPE-2 trial [2] - Following the announcement of a Complete Response Letter (CRL) from the FDA on July 11, 2025, which denied the BLA due to insufficient evidence of effectiveness, Capricor's stock price fell from $11.40 to $7.64 per share [2] Group 2: Next Steps for Investors - Investors who suffered losses during the relevant period have until September 15, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing significant settlements for shareholders and is recognized as one of the top securities litigation firms in the United States [4]

Group 1 - The Rosen Law Firm has filed a class action lawsuit on behalf of purchasers of Capricor Therapeutics, Inc. securities between October 9, 2024, and July 10, 2025 [1] - Investors who purchased Capricor securities during the class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A lead plaintiff must move the Court by September 15, 2025, to represent other class members in the litigation [3] Group 2 - The lawsuit alleges that Capricor provided misleading information regarding its lead cell therapy candidate, deramiocel, while concealing adverse facts about its safety and efficacy data from a Phase 2 trial [5] - The misleading statements led to shareholders purchasing Capricor's securities at artificially inflated prices, resulting in damages when the true information was revealed [5] Group 3 - The Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements in recovering significant amounts for investors [4]

Core Insights - Capricor Therapeutics is hosting a webinar on July 29, 2025, to discuss the status of its Biologics License Application (BLA) for Deramiocel and provide information on cardiomyopathy in Duchenne Muscular Dystrophy (DMD) [1][2] - Deramiocel is an allogeneic cardiac-derived cell therapy currently in late-stage development for DMD, demonstrating potent immunomodulatory and anti-fibrotic actions [3][5] - Capricor has entered an exclusive commercialization agreement for Deramiocel in the U.S. and Japan with Nippon Shinyaku Co., Ltd., pending regulatory approval [5] Company Overview - Capricor Therapeutics focuses on developing cell and exosome-based therapeutics for rare diseases, with a commitment to innovative treatments [3] - The company utilizes its proprietary StealthX™ platform for preclinical development in various therapeutic areas, including vaccinology and targeted delivery [3] Webinar Details - The webinar will include a review of the BLA status for Deramiocel and a Q&A session with the community [1] - A replay of the webinar will be available on the Parent Project Muscular Dystrophy (PPMD) website [2]

Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action lawsuit due to allegations of misleading statements regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][2]. Group 1: Allegations and Impact - The lawsuit claims that Capricor provided investors with overly positive information about its ability to obtain a Biologics License Application (BLA) from the FDA while concealing adverse facts about the safety and efficacy data from its Phase 2 HOPE-2 trial [1]. - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, denying the BLA due to insufficient evidence of effectiveness and the need for additional clinical data, leading to a stock price drop from $11.40 to $7.64 per share [1]. Group 2: Class Action Details - Shareholders who purchased shares during the class period from October 9, 2024, to July 10, 2025, are encouraged to register for the class action, with a deadline of September 15, 2025, to seek lead plaintiff status [2]. - Registered shareholders will receive updates through a portfolio monitoring software throughout the case lifecycle, with no cost or obligation to participate [2]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud, ensuring companies adhere to responsible business practices [3].

NEW YORK, July 28, 2025 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP announces that a shareholder has filed a securities class action lawsuit on behalf of investors (the "Class") who purchased or acquired the securities of Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ: CAPR) between October 9, 2024 and July 10, 2025, inclusive. ATTORNEY ADVERTISING. © 2025 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New Y ...

Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action securities lawsuit due to alleged securities fraud related to its lead cell therapy candidate, deramiocel, which is intended for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][2] Group 1: Lawsuit Details - The lawsuit aims to recover losses for investors affected by alleged fraud between October 9, 2024, and July 10, 2025 [1] - Defendants allegedly provided misleading information regarding Capricor's ability to secure a Biologics License Application (BLA) from the FDA for deramiocel while concealing adverse facts about its Phase 2 HOPE-2 trial data [2] - Following the announcement of a Complete Response Letter (CRL) from the FDA on July 11, 2025, which denied the BLA due to insufficient evidence of effectiveness, Capricor's stock price fell from $11.40 to $7.64 per share [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until September 15, 2025, to request appointment as lead plaintiff in the lawsuit [3] - Participation in the lawsuit does not require serving as a lead plaintiff, and there are no out-of-pocket costs for class members [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the U.S. [4]

Core Viewpoint - A class action lawsuit has been filed against Capricor Therapeutics, Inc. for allegedly misleading investors about the viability of its lead product candidate, deramiocel, during a specific period [1][2]. Company Overview - Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell and exosome-based therapeutics for Duchenne muscular dystrophy (DMD) and other diseases with unmet medical needs in the U.S. [1]. Allegations - The lawsuit claims that during the class period, Capricor misled investors regarding the effectiveness of deramiocel for treating cardiomyopathy associated with DMD, creating a false impression of its approval prospects while concealing adverse safety and efficacy data from its Phase 2 HOPE-2 trial [2]. - The complaint highlights that Capricor's misleading statements led to shareholders purchasing securities at artificially inflated prices [2]. Recent Developments - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, which denied its Biologics License Application, citing insufficient evidence of effectiveness and the need for additional clinical data [3]. - Following the announcement, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025, reflecting a significant decline in investor confidence [3].