Cytokinetics ACACIA-HCM Phase 3 Trial Hits Both Endpoints in Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy; Simultaneous NEJM Publication at ESC 2026 Munich
Cytokinetics (NASDAQ: CYTK) presented Friday August 28, 2026 the full results from the Phase 3 ACACIA-HCM trial of Myqorzo (aficamten, a next-generation cardiac myosin inhibitor) in adults with symptomatic non-obstructive hypertrophic cardiomyopathy at the European Society of Cardiology Congress 2026 in Munich, Germany, with simultaneous publication in The New England Journal of Medicine. The trial met both dual primary endpoints with statistically significant improvements from baseline to Week 36 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and peak oxygen uptake (peak VO2) versus placebo, plus improvements on key secondary endpoints. LVEF <50% occurred in 10% of aficamten patients vs 1% on placebo, with rare treatment interruptions due to LVEF <40% and two serious heart failure adverse events associated with LVEF <50%. Cytokinetics plans to submit a Supplemental New Drug Application in Q4 2026. There are no currently-approved therapies for non-obstructive HCM, and the ACACIA readout positions aficamten as the potential first-in-class treatment for this indication after the July 2026 initial obstructive-HCM approval.