Kirby McInerney LLP reminds Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ:CAPR) investors of the September 15, 2025 deadline to seek the role of lead plaintiff in a pending federal securities class action.
If you purchased or otherwise acquired Capricor securities, have information, or would like to learn more, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the form below, to discuss your rights or interests.
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What Happened?
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 $3.00 per share, or approximately 29.13%, from $10.30 per share on May 5, 2025 to close at $7.30 on May 6, 2025.
On July 11, 2025, Capricor announced that it received a Complete Response Letter (CRL) from 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 shares declined by $3.76 per share, or approximately 32.98%, from $11.40 per share on July 10, 2025 to close at $7.64 on July 11, 2025.
What Is The Lawsuit About?
The lawsuit has been filed on behalf of investors who purchased securities during the period of October 9, 2024 through July 10, 2025, inclusive ("the Class Period"). The lawsuit alleges that Capricor provided investors with material information concerning Capricor's lead cell therapy candidate drug deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Defendants' statements included, among other things, Capricor's ability to obtain a Biologics License Application (BLA) for deramiocel from the U.S. Food and Drug Administration (FDA). Defendants provided these 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. On July 11, 2025, Capricor issued a press release announcing it received a Complete Response Letter (CRL) from the FDA denying the BLA 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.
[CLICK HERE TO LEARN MORE ABOUT THE CLASS ACTION]
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Kirby McInerney LLP
Thomas W. Elrod, Esq.
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https://www.kmllp.com
investigations@kmllp.com
