Capricor Therapeutics announces Type B meeting with FDA for CAP-1002 program

Capricor Therapeutics announced an update from the Company’s recent Type-B Chemistry, Manufacturing and Controls meeting with the U.S. Food and Drug Administration on next steps for the Biologics License Application submission with its lead asset CAP-1002 in treating Duchenne muscular dystrophy. The FDA has affirmed alignment with Capricor on the following topics: Pre-BLA Meeting and Rolling BLA Submission: The FDA advised Capricor to include discussion for a pre-BLA meeting and rolling BLA schedule in the upcoming Type-B meeting. Based on this feedback, Capricor has already been granted a subsequent Type-B meeting to be held in the second quarter of 2024 to discuss these topics, with the results of those discussions to potentially lead to an accelerated BLA filing. Capricor plans to share with FDA its HOPE-2 open label extension 3-year safety and efficacy data which is expected to be available in the second quarter of 2024 as part of Capricor’s ISS and ISE strategy. Establishment of Non-Clinical Comparability: The FDA agreed that comparability between drug product manufactured at our two different facilities has been demonstrated using the provided analytical comparability data. This allows for the use of CAP-1002 drug product manufactured at our San Diego manufacturing facility upon potential product approval. Data from Cohort B of the HOPE-3 clinical trial will not be necessary for FDA approval of the product.