Capricor Therapeutics Cell Therapy Goes Under Priority FDA Review For Duchenne Associated-Heart Condition

Core Points - The FDA has accepted Capricor Therapeutics Inc's Biologics License Application for deramiocel, aimed at treating Duchenne muscular dystrophy (DMD) cardiomyopathy [1] - The FDA granted Priority Review status with a target action date of August 31, 2025 [1] - No potential review issues have been identified by the FDA [2] Company and Industry Summary - The BLA submission is supported by data from Capricor's Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials, which were compared to natural history data [3] - The FDA has not yet determined if an Advisory Committee meeting will be necessary for this application [3] - Deramiocel has received Orphan Drug Designation from both the FDA and the European Medicines Agency [4] - If approved by September 30, 2026, Capricor could receive a Priority Review Voucher due to its previous rare pediatric disease designation [4] - CAPR stock increased by 6.33% to $14.54 following the news [4]