Capricor Therapeutics, Inc. resumes Deramiocel BLA review as FDA sets August 22, 2026 deadline

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Olga Shendetskaya

10.03.2026

Capricor Therapeutics, Inc. resumes Deramiocel BLA review as FDA sets August 22, 2026 deadline — FDA resumes Deramiocel review

Capricor Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has resumed its review of the Biologics License Application (BLA) for Deramiocel, a therapy developed for the treatment of Duchenne muscular dystrophy.

The FDA has scheduled a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026, providing a clear timeline for its decision. The company shared this update to inform stakeholders and the Duchenne muscular dystrophy community of the regulatory progress. Further updates will be provided as new developments arise.

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