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On Friday, H.C. Wainwright reaffirmed a Buy rating with a price target of $77.00 on Capricor Therapeutics (NASDAQ:CAPR) shares. The firm's analyst highlighted the completion of a rolling Biologics License Application (BLA) filing with the U.S. Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy using deramiocel, previously known as CAP-1002.
The BLA submission, announced on January 2, was completed on schedule and prompted a $10 million milestone payment to Capricor from its partner, Nippon Shinyaku. The data presented in the BLA emphasized the benefits of deramiocel for DMD-related cardiomyopathy, drawing from results of the Phase 2 HOPE-2 and the open label extension (OLE) trials, as well as comparisons with patient-level natural history data.
The FDA is expected to provide feedback on the submission in the first quarter of 2025. Capricor is optimistic about receiving a Priority Review designation, which could lead to a potential Prescription Drug User Fee Act (PDUFA) date in the second half of 2025.
In anticipation of approval and market launch, Capricor is actively preparing for commercialization. Efforts include ramping up pre-commercial activities, expanding manufacturing capabilities, and forging strategic partnerships to support the successful introduction of deramiocel in both the U.S. and international markets.
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