NEW YORK, July 18, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
The investigation concerns whether Capricor and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
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May 5, 2025, Capricor issued a press release announcing that after “the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company’s Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy”, the FDA had “confirmed its intent to hold an advisory committee meeting” in connection with the BLA.
On this news, Capricor’s stock price fell $3.00 per share, or 29.13%, to close at $7.30 per share on May 6, 2025.
Then, on June 20, 2025 the publication STAT reported that the new head of the relevant FDA unit had canceled the advisory committee meeting for deramiocel due to uncertainty about the drug’s efficacy and safety.
On this news, Capricor’s stock price fell $3.68 per share, or 30.82%, to close at $8.26 per share on June 20, 2025.
Then, on July 11, 2025, Capricor announced receipt of a Complete Response Letter (“CRL”) from the FDA regarding the deramiocel BLA. Capricor said that “[i]n the CRL, the FDA stated that it had completed its review of the application but is unable to approve the BLA in its current form, specifically citing that the BLA does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.”
On this news, Capricor’s stock price fell $3.76 per share, or 32.98%, to close at $7.64 per share on July 11, 2025.
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CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980
