FDA resumes review of Capricor's Deramiocel BLA, sets new PDUFA action date of August 22

 

FDA resumes review of Capricor's Deramiocel BLA, sets new PDUFA action date of August 22, 2026

• FDA lifted its prior Complete Response Letter on Deramiocel and formally resumed review of the biologics license application.
• Company is positioned for potential Priority Review Voucher eligibility upon Deramiocel approval, according to Capricor Therapeutics.

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