Capricor Therapeutics Announces Follow-up Type-B Clinical Meeting with the FDA for CAP-1002 for the Treatment of Duchenne Muscular Dystrophy

Biotechnology company Capricor Therapeutics has announced a Type-B clinical meeting with the US Food and Drug Administration (FDA) for its treatment, CAP-1002, for Duchenne muscular dystrophy. The meeting will take place in early Q3 2023 and will outline Capricor's path towards submitting a potential Biologics License Application as well as discussing its ongoing HOPE-3 clinical trial with the FDA. Capricor CEO Linda Marbán said the company expected to complete enrollment by H2 2023 and would report an interim analysis of HOPE-3 in Q4 2023. If approved, CAP-1002 would be eligible to receive a Priority Review Voucher based on its designation as a rare pediatric disease.