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 decision comes as the FDA continues to review additional information submitted by Capricor following a negative advisory committee vote.
The extension of the PDUFA target action date allows the FDA more time to evaluate the data provided by Capricor, which is crucial for the potential approval of the cell therapy aimed at treating Duchenne muscular dystrophy.
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.”
fierce biotech — <a href="/biotech/capricor-secures-reprieve-fda-extends-dmd-cell-therapy-review" hreflang="en">Capricor secures reprieve as FDA extends DMD cell therapy review</a>