Cytokinetics announces FDA extends aficamten PDUFA date to Dec 26, 2025 on REMS review

CYTOKINETICS INC

FDA extended PDUFA date for aficamten NDA in oHCM to December 26, 2025, a three-month extension.
Extension due to FDA requesting a Risk Evaluation and Mitigation Strategy (REMS) as a Major Amendment.
No additional clinical data or studies requested; NDA originally filed without REMS.
Cytokinetics submitted the REMS after FDA request; review continues.

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