Capricor Therapeutics announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne. The new PDUFA date is now November 22, 2026.
After the FDA Advisory Committee Meeting in July, Capricor submitted an amendment to the BLA that includes additional data from the open label extension of their pivotal HOPE-3 study, with a request that the FDA focus on upper limb function in their consideration of approval. The FDA has extended the PDUFA target action date by three months to allow additional time to review the information.
Link to press release: https://www.capricor.com/investors/news-events/press-releases/detail/354/capricor-therapeutics-announces-extension-of-pdufa-target
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