NEWS
Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA Pathway
Capricor Therapeutics (NASDAQ: CAPR) announced a successful Type-B meeting with the FDA for their lead asset, CAP-1002, aimed at treating Duchenne muscular dystrophy (DMD). The FDA approved a rolling Biologics License Application (BLA) submission, set to begin in Q3 2024. The rolling BLA process could streamline regulatory review and reduce risks. The company also received positive clinical results from their HOPE-2 and HOPE-2 OLE studies, with additional data pending from the HOPE-3 trial. The WHO selected 'Deramiocel' as the International Nonproprietary Name for CAP-1002. Capricor could also receive a Priority Review Voucher following FDA approval due to its rare pediatric disease designation. This regulatory progress signifies pivotal steps toward the potential commercialization of CAP-1002.
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