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On Tuesday, the FDA accepted for review Capricor Therapeutics Inc’s (NASDAQ: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, …