Cytokinetics says Phase 3 ACACIA-HCM data show aficamten boosts exercise performance in non-obstructive HCM
CYTK•Cytokinetics said additional ACACIA-HCM analyses showed broader exercise-performance improvements with aficamten versus placebo in non-obstructive HCM. The company plans to file a supplemental New Drug Application with the FDA this quarter.
1. Trial analysis findings
Additional ACACIA-HCM analyses presented at the HFSA Annual Scientific Meeting 2026 showed broader exercise-performance improvement with aficamten versus placebo, alongside better patient-reported health status and supportive biomarker trends. A responder analysis found more patients taking aficamten achieved meaningful overall clinical benefit across multiple domains than patients taking placebo.
2. Safety and filing plans
Heart-failure events were concentrated during early dose titration, the safety updates showed, supporting an approach guided by monitoring heart-pumping function. Cytokinetics plans to file a supplemental New Drug Application with the FDA this quarter to expand aficamten’s label into non-obstructive HCM.
