Capricor Therapeutics Announces Initiation Of Rolling Submission Of BLA With U.S. FDA For Deramiocel For The Treatment Of Duchenne Muscular Dystrophy
Portfolio Pulse from Benzinga Newsdesk
Capricor Therapeutics has started the rolling submission of a Biologics License Application (BLA) with the FDA for deramiocel, aimed at treating Duchenne muscular dystrophy. The company plans to complete the submission by the end of 2024, potentially qualifying for priority review.
October 09, 2024 | 1:17 pm
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Capricor Therapeutics has initiated a rolling BLA submission with the FDA for deramiocel, targeting Duchenne muscular dystrophy. The process is expected to conclude by the end of 2024, with a chance for priority review.
The initiation of the BLA submission is a significant regulatory step for Capricor Therapeutics, indicating progress in their product pipeline. The potential for priority review by the FDA could expedite the approval process, positively impacting the stock price.
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