Cytokinetics' aficamten meets both primary endpoints in Phase 3 ACACIA-HCM nHCM trial

CYTOKINETICS INC

ACACIA-HCM met both dual primary endpoints: KCCQ-CSS LSM diff 3.0 (p=0.021) and pVO2 diff 0.67 ml/kg/min (p=0.003) at Week 36.
First Phase 3 trial to show statistically significant improvements in non-obstructive HCM; results published in NEJM and presented at ESC 2026.
sNDA for aficamten in symptomatic nHCM to be submitted to FDA in Q4 2026.
Safety: LVEF <50% in 10.5% of aficamten patients vs 0.8% placebo; SAEs 20.2% vs 14.7%.
Global efficacy: 53% of aficamten patients responded in 3+ outcome measures vs 13% placebo (p<0.001).

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