Capricor Therapeutics, Inc. Stock News

OAKLAND, Calif.--(BUSINESS WIRE)---- $CAPR #CAPR--Shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on Friday, July 11, 2025, after the U.S. Food and Drug Administration rejected the company's Biologics License Application for its lead cell therapy candidate, Deramiocel, claiming that the application “does not meet the statutory requirement for substantial evidence of e...

ATLANTA, July 11, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) complied with federal securities laws. On July 11, 2025, Capricor announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding its Biologics License Application (“BLA”) for Deramiocel. Following this news, t...

Capricor Therapeutics (NASDAQ:CAPR) shares plummeted more than 26% after it reported the US Food and Drug Administration (FDA) has not approved its Biologics License Application for deramiocel, the company's lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). In a Complete Response Letter to Capricor, the FDA stated that the applica...

Capricor Therapeutics plummeted Friday after the FDA rejected its experimental treatment for cardiomyopathy associated with DMD.

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy for a type of muscle disorder.

SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the Company's lead cell ...

Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration will not convene its panel of outside experts before deciding on the company's cell therapy for a heart condition associated with Duchenne muscular dystrophy.

SAN DIEGO, June 20, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced positive four-year safety and efficacy results from its ongoing HOPE-2 Open-Label Extension (OLE) study of Deramiocel, the Company's lead cell therapy candidate for Duchenne Muscular Dystrophy ...