Capricor Therapeutics Announces Extension of PDUFA Target Action Date for Deramiocel BLA
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Capricor Therapeutics has announced that the FDA has extended its review of the company's Duchenne muscular dystrophy drug candidate, Deramiocel. This extension comes as the FDA continues to review information submitted by Capricor following a negative advisory committee vote.
The new PDUFA target action date has been set as the FDA evaluates the additional data provided by the biotech firm. This decision allows Capricor more time to address the concerns raised during the advisory committee meeting.
Capricor TherapeuticsFDA
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“Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA”
SEC Filing — Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA“The FDA has extended its review of Capricor Therapeutics’ Duchenne muscular dystrophy drug candidate, deferring the decision to review information the biotech submitted after a negative advisory committee vote.”
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