Cytokinetics: FDA won't hold adcom for aficamten NDA; Late Cycle meeting set for June 2025

CYTOKINETICS INC

Cytokinetics completed midcycle review with FDA for aficamten NDA treating obstructive hypertrophic cardiomyopathy.
FDA informed Cytokinetics it does not plan to convene an advisory committee meeting for the aficamten NDA.
Late Cycle meeting with FDA expected in June 2025; company maintains expectation for differentiated label and risk mitigation if approved.
Cytokinetics does not plan to share detailed updates on FDA communications beyond this update.

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