Capricor completes BLA on time, requests priority review, says H.C. Wainwright

Capricor on Thursday announced that it completed its rolling biologics license application filing with the Food and Drug Administration on time for the treatment of Duchenne muscular dystrophy cardiomyopathy with deramiocel, with the event triggering a $10M milestone payment from partner Nippon Shinyaku, H.C. Wainwright tells investors in a research note. Tghe firm, which made no change to its Buy rating or $77 price target says FDA feedback is expected in the first quarter of 2025, and the company anticipates a potential Prescription Drug User Fee Act date in the second half of the year, if not sooner, if a priority review is granted, which the firm believes it will be.