Capricor Therapeutics recently shared an update on the FDA review of their investigational therapy, deramiocel. The company shared that the Biologics License Application (BLA) for deramiocel remains under FDA review as it prepares an amendment seeking a narrower DMD indication focused on upper-limb skeletal muscle function.
Capricor said the FDA has indicated it will review the planned amendment and extend the Prescription Drug User Fee Act (PDUFA) action date (currently August 22, 2026) after submission. Capricor is finalizing timing and expects to include 24-month open-label extension data from HOPE-3, along with additional analyses of its existing data package.
Read Capricor’s press release HERE
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