Capricor announces establishment of new PDUFA date for dermiocel BLA

Capricor Therapeutics (CAPR) announced that the U.S. Food and Drug Administration has lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act target action date of August 22, 2026. The Company received a Complete Response Letter from the FDA in July 2025. Following submission of data and supporting documentation from the HOPE-3 clinical trial, the FDA resumed review of the application and assigned a PDUFA target action date of August 22, 2026. At this time, the FDA has not identified any potential review issues in its response to the Company. Capricor also expects to be eligible to receive a Priority Review Voucher upon potential approval of Deramiocel.