FDA Resumes Review of Capricor’s Deramiocel, Sets 2026 PDUFA Date

Key Facts

1The U.S. FDA lifted the previously issued Complete Response Letter and resumed review of the Biologics License Application (BLA) for Deramiocel.

2A new PDUFA target action date has been set for August 22, 2026.

3The therapy targets Duchenne muscular dystrophy (DMD) cardiomyopathy.

Capricor Therapeutics (NASDAQ: CAPR) announced that the U.S. Food and Drug Administration (FDA) has officially resumed its review of the Biologics License Application (BLA) for its cell therapy, Deramiocel. This significant development follows the FDA's decision to lift a previously issued Complete Response Letter (CRL), effectively removing a major regulatory hurdle for the company. The agency has established a new PDUFA target action date of August 22, 2026, for its final decision. Deramiocel is designed to treat cardiomyopathy associated with Duchenne muscular dystrophy (DMD), a rare and debilitating genetic disorder. The FDA has classified the submission as a Class 2 resubmission, providing a structured pathway toward potential commercialization. This resumption marks a pivotal milestone for Capricor, offering investors a clear timeline for the therapy's potential market entry.