Capricor Therapeutics Cell Therapy Goes Under Priority FDA Review For Duchenne Associated-Heart Condition
1. FDA accepted Capricor's BLA for deramiocel treatment. 2. Priority Review granted with action date set for August 31, 2025. 3. No review issues identified by the FDA. 4. Submission supported by Phase 2 trial data. 5. Potential for Priority Review Voucher upon FDA approval.