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

On Tuesday, the FDA accepted for review Capricor Therapeutics Inc’s CAPR Biologics License Application for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.DMD cardiomyopathy is a heart condition characterized by cardiac fibrosis, arrhythmias, and heart failure. Additionally, the FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of August 31, 2025.The FDA has not identif ...