The law firm of Kirby McInerney LLP reminds investors who purchased Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) securities to contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to the securities fraud class action lawsuit against the Company.

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On May 5, 2025, Capricor issued a press release announcing it had completed its mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate drug deramiocel. The Company announced that the review committee found no significant deficiencies and that the package was on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. The FDA confirmed its intent to hold an advisory committee meeting. On this news, the price of Capricor shares declined by approximately 29.13%, from $10.30 per share on May 5, 2025 to $7.30 per share on May 6, 2025.

On July 11, 2025, Capricor announced that it received a Complete Response Letter (CRL) from the FDA denying the Company’s Biologics License Application (BLA) for deramiocel. The CRL cited Capricor’s failure to meet the requirement for evidence of effectiveness and the need for additional clinical data. Further, the CRL referenced outstanding items in the Chemistry, Manufacturing, and Controls section of the application. On this news, the price of Capricor stock declined from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025.

According to the lawsuit, Capricor’s statements regarding its ability to obtain a BLA for deramiocel from the FDA were misleading. The Company provided overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel.

If you purchased or otherwise acquired Capricor securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters without any cost to you.

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Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.

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