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# Cytokinetics NDA Filed for Hypertrophic Cardiomyopathy
- URL: https://www.fdaweb.com/cytokinetics-nda-filed-for-hypertrophic-cardiomyopathy/
- Published: 2024-12-03T12:00:00.000Z
- Updated: 2026-09-14T14:48:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158296

FDA has accepted for review a Cytokinetics NDA for aficamten, a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (HCM). The agency set a user fee review action target date of 9/26/2025.

The submission is based on data from the Phase 3 SEQUOIA-HCM pivotal trial, which demonstrated that aficamten has a “positive impact on exercise capacity, clinical outcomes, symptom burden and cardiac biomarkers in patients with HCM, with a consistent effect across all prespecified subgroups and a favorable safety and tolerability profile,” the company says.

Cytokinetics says aficamten was designed to “reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with HCM.” In preclinical models, the drug was shown to reduce myocardial contractility by binding directly to cardiac myosin to prevent it from entering a force producing state, it says.