Gainey McKenna & Egleston Announces A Class Action Lawsuit Has Been Filed Against Capricor Therapeutics, Inc. (CAPR)

NEW YORK, July 18, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of all persons or entities who purchased or otherwise acquired Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) securities between October 9, 2024 and July 10, 2025, both dates inclusive (the “Class Period”).

The Complaint alleges that Defendants misled investors concerning Capricor’s lead cell therapy candidate drug deramiocel for the treatment of cardiomyopathy associated with DMD. Defendants gave the false impression that they could obtain first approval for DMD cardiomyopathy, while, at the same time, concealing material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel.

The Complaint further that on July 11, 2025, Capricor issued a press release announcing it received a Complete Response Letter (CRL) from the FDA denying the Biologics License Application specifically citing it did not meet the statutory requirement for substantial 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. As a result, the price of Capricor stock declined from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025.

Investors who purchased or otherwise acquired shares of Capricor should contact the Firm prior to the September 15, 2025 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.

Please visit our website at http://www.gme-law.com for more information about the firm.

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