Aficamten - (ACACIA-HCM)

Oct. 12, 2026: Cytokinetics (NASDAQ: CYTK) reported additional Phase 3 ACACIA-HCM analyses for aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) at the HFSA Annual Scientific Meeting 2026 and said it plans to submit a supplemental NDA to the FDA in Q4 2026.

A prespecified exercise-performance analysis showed aficamten significantly improved the 2026 Boston Exercise Aggregate Physiologic Response Score versus placebo at 36 weeks (p<0.001), with gains across all five exercise/recovery domains. BEAP-RS improvement correlated with KCCQ-CSS (p=0.001), NYHA class (p=0.001), and NT-proBNP (p<0.001).

A global responder analysis found more aficamten-treated patients achieved clinically meaningful improvement across five domains, with statistically significant benefit in four: symptom relief, lower left atrial volume index, higher septal e’ velocity, and at least 50% NT-proBNP reduction (all p<0.05). Peak VO2 improvement of at least 0.5 mL/kg/min occurred in 45% vs 37% on placebo (p=0.1). Overall, 53% on aficamten responded in at least 3 domains vs 13% on placebo (p<0.001).

Safety/titration data showed 80.7% ended titration on 15 or 20 mg. LVEF <50% occurred in 10.5% vs 0.8%; serious heart-failure AEs occurred in 4.7% vs 1.2%, mainly during titration or before Week 12.