Aficamten - (ACACIA-HCM)

Aug. 28, 2026: Cytokinetics (NASDAQ: CYTK) reported pivotal Phase 3 ACACIA-HCM results for aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) at ESC Congress 2026, with simultaneous NEJM publication. The trial met both dual primary endpoints at Week 36 versus placebo: KCCQ-CSS improved by 11.4 vs 8.4 points (LSM difference 3.0; 95% CI 0.5-5.5; p=0.021) and peak VO2 improved by 0.64 vs -0.03 mL/kg/min (difference 0.67; 95% CI 0.22-1.1; p=0.003).

Key secondary endpoints were also significant, including at least 1 NYHA class improvement (41.9% vs 27.8%; p<0.001), CPET composite z-score (p<0.001), and NT-proBNP reduction (p<0.001). Left atrial volume index (p=0.058) and time to first cardiovascular event (p=0.678) were not significant. A global efficacy analysis showed improvement across five domains (p<0.001), with 53% of aficamten patients responding in at least 3 measures vs 13% on placebo.

Safety: serious adverse events occurred in 20.2% on aficamten vs 14.7% on placebo; LVEF <50% occurred in 10.5% vs 0.8%. Cytokinetics said it plans a supplemental NDA to FDA in Q4 2026 for aficamten in adult symptomatic nHCM.