Capricor Therapeutics announced the completion of a Type-B meeting with the U.S. Food and Drug Administration on next steps for the Biologics License Application submission with its lead asset, CAP-1002 for the treatment of Duchenne muscular dystrophy. Additionally, Deramiocel has been selected as the proposed International Nonproprietary Name for CAP-1002 by the World Health Organization. The rolling submission process allows for the submission of pre-agreed components of the BLA to be submitted as they are completed, which can streamline the regulatory review process and de-risk the BLA. Capricor plans to further outline the submission schedule with the FDA in the coming months.
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