Capricor Therapeutics Updates Deramiocel BLA Timeline and Manufacturing Validation Goals
Capricor Therapeutics (CAPR) has provided an update regarding its Biologics License Application (BLA) for Deramiocel. The company confirmed that the FDA is in the final stages of reviewing the application, though a major amendment requiring additional data review has resulted in an extended PDUFA target date of November 22. In addition to regulatory progress, Capricor outlined its roadmap for manufacturing validation, which is currently projected for completion by 2027. This timeline is critical as the company prepares for potential commercialization following the FDA's decision.
Tickers: $CAPR
Topics: Biotechnology BLA Status FDA Review PDUFA Extension
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Part of the story Capricor Therapeutics shares rise as FDA decision nears (3 articles)