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FDA Extends Capricor’s Deramiocel PDUFA Date to November 22, 2026

Capricor Therapeutics logoCapricor Therapeutics
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Capricor Therapeutics said the FDA extended the PDUFA target action date for its Deramiocel BLA by three months to November 22, 2026, from August 22, 2026. The FDA classified the BLA amendment as a major amendment, extending the review period. Capricor is seeking review to support a refined indication focused on upper limb function.

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