Capricor PDUFA date for Deramiocel DMD therapy shifts to Nov. 22, 2026 after FDA review extension - CAPR News | RalliesCapricor PDUFA date for Deramiocel DMD therapy shifts to Nov. 22, 2026 after FDA review extension
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CAPR• FDA extends review timeline for Deramiocel
- FDA extended the PDUFA target action date for Capricor’s Deramiocel BLA to Nov. 22, 2026 from Aug. 22, 2026.
- The delay follows a major BLA amendment adding 24-month HOPE-3 open-label extension data and additional analyses.
- CBER accepted the amendment for review, extending the timeline by three months to evaluate the new submission.
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