Capricor Responds To FDA's Unexpected Public Release Of CRL For Duchenne Cell Therapy; Will Publish Its Rebuttal Online For Transparency

Author: Benzinga Newsdesk | September 09, 2025 09:21am

Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today issued a statement regarding the U.S. Food and Drug Administration's (FDA) public posting of its Complete Response Letter (CRL) for the Biologics License Application (BLA) for Deramiocel, the Company's investigational cell therapy for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

The Company was not notified in advance that the CRL would be posted, but acknowledges the FDA's decision to publish the letter, originally received in July 2025. However, the FDA did not release the comprehensive preliminary response that Capricor submitted shortly after receipt of the CRL. This written response provided clarifications to the Agency's feedback and outlined the Company's proposed plan to address the outstanding issues. To ensure transparency, Capricor will make its preliminary response available on the investor section of its website for patients, families, and other stakeholders to review.

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