Capricor Therapeutics receives FDA acceptance of BLA for deramiocel

NS Pharma, a subsidiary of Nippon Shinyaku Co., announced that acceptance has been received by Capricor Therapeutics (CAPR) from the U.S. FDA for the Biologics License Application filing for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy cardiomyopathy. The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act target action date of August 31, 2025, and at this time, the FDA has not identified any potential review issues.