Capricor Therapeutics received positive feedback from a Type-B CMC meeting with the FDA for its lead asset, CAP-1002, in treating DMD.
Capricor Therapeutics received positive feedback from a recent Type-B CMC meeting with the FDA for its lead asset, CAP-1002, in treating Duchenne muscular dystrophy (DMD). The FDA aligned with Capricor on certain topics, such as a pre-BLA meeting and rolling BLA schedule. Capricor was granted a subsequent Type-B meeting in Q2 2024 to discuss these topics further, which may potentially lead to accelerated BLA.
April 24, 2024
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