Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy

Core Viewpoint - The FDA has extended the PDUFA action date for Cytokinetics' aficamten to December 26, 2025, due to the need for additional time to review the proposed REMS [1][2]. Group 1: FDA Review Process - Cytokinetics submitted the NDA for aficamten without an accompanying REMS, which was later requested by the FDA during the review process [2]. - The submission of the REMS is considered a Major Amendment to the NDA, resulting in a standard three-month extension to the original PDUFA action date [2]. Group 2: Company Confidence and Product Pipeline - The company remains confident in the benefit-risk profile of aficamten and anticipates a differentiated label and risk mitigation profile upon potential FDA approval [3]. - Cytokinetics is advancing a pipeline of potential new medicines for cardiac muscle dysfunction, including aficamten, omecamtiv mecarbil, CK-586, and CK-089 [3].