On March 10, 2025, Cytokinetics disclosed that the U.S. Food and Drug Administration ("FDA") had decided not to convene an advisory committee meeting to review the Company's New Drug Application ("NDA") for aficamten. On May 1, 2025, Cytokinetics announced that the FDA had extended the Prescription Drug User Fee Act action date for aficamten's NDA from September 26, 2025 to December 26, 2025 in order to review a Risk Evaluation and Mitigation Strategy ("REMS") submitted at the FDA's request after the initi ...