Capricor Therapeutics

CAPR

Market cap $306M

Capricor allegedly misled investors about its DMD therapy's FDA approval prospects; an FDA rejection letter citing lack of efficacy data sent shares down.

SAN DIEGO, Oct. 03, 2025 (GLOBE NEWSWIRE) -- Johnson Fistel, PLLP is investigating potential legal claims on behalf of Capricor Therapeutics, Inc. (NASDAQ: CAPR) shareholders, concerning alleged misconduct by certain officers and directors that may have harmed the company and its investors.

Capricor Therapeutics is advancing deramiocel (CAP-1002) for DMD cardiomyopathy, with a BLA resubmission and HOPE-3 topline data expected by 2026. CAPR's therapy addresses a critical unmet need in non-ambulatory DMD patients, offering a unique mechanism and favorable safety profile compared to gene therapies like Elevidys. Strong regulatory designations, strategic partnerships, and a robust cash position support ongoing R&D, despite elevated burn and recent FDA setbacks.

Based on prior, preclinical and clinical data, including 2 small randomized trials, I believe there is a high probability that Capricor Therapeutics' phase 3 trial will be positive. Topline results are expected this November. PUL 2.0 (a skeletal muscle endpoint) remains the primary endpoint, with left ventricle ejection fraction being a key secondary endpoint. Regulatory uncertainty remains on the scenario of HOPE 3 meeting the cardiac endpoint, but failing the primary skeletal muscle endpoint.

Capricor (CAPR) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Capricor Therapeutics, Inc. - Special Call Company Participants Anthony Bergmann - CFO & Corporate Treasurer Linda Marbán - Co-Founder, President, CEO & Director Conference Call Participants Joseph Pantginis - H.C. Wainwright & Co, LLC, Research Division Kristen Kluska - Cantor Fitzgerald & Co., Research Division Madison Wynne El-Saadi - B.

SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced a regulatory update for its Biologics License Application (BLA) for Deramiocel, the Company's investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). This update follows a recent Type A meeting with the U.S. Food and Drug Administration (FDA) after the receipt of a Complete Response Letter (CRL) in July 2025.

SAN DIEGO, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Johnson Fistel, PLLP is investigating potential legal claims on behalf of Capricor Therapeutics, Inc. (NASDAQ: CAPR) shareholders, concerning alleged misconduct by certain officers and directors that may have harmed the company and its investors.

Bragar Eagel & Squire, P.C. Litigation Partner  Brandon Walker  Encourages Investors Who Suffered Losses In Capricor (CAPR) To Contact Him Directly To Discuss Their Options If you are a long-term stockholder in  Capricor between October 9, 2024 and July 10, 2025 and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Marion Passmore directly at (212) 355-4648.

NEW YORK , Sept. 15, 2025 /PRNewswire/ --  Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Capricor Therapeutics, Inc. (NASDAQ: CAPR) between October 9, 2024 and July 10, 2025, both dates inclusive (the "Class Period"), of the important September 15, 2025 lead plaintiff deadline.