Capricor Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has lifted the July 2025 Complete Response Letter and resumed review of the company’s Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for the treatment of Duchenne cardiomyopathy. The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026, the date by which the agency plans to complete its review and decide whether to approve the therapy.
This update comes after Capricor submitted additional information to the agency—including data from the HOPE-3 trial, which the company indicated in December 2025 was consistent with FDA guidance that HOPE-3 results should be sufficient to support regulatory approval. According to Capricor, the company also expects to be eligible to receive a Priority Review Voucher (“PRV”) upon potential approval of Deramiocel.
PPMD is encouraged by this news, and we appreciate both the FDA’s efforts to conduct a thorough review and ensure safety, as well as Capricor’s commitment to collaboration with the FDA throughout this process. We will share additional updates as they become available.
Read Capricor’s press release here.
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