Aficamten achieves dual-endpoint success in pivotal non-obstructive HCM trial

Cytokinetics announced positive topline results from ACACIA-HCM, a pivotal Phase 3 trial of aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy, meeting both primary endpoints (KCCQ-CSS and maximal exercise capacity pVO2) at Week 36 with statistical significance (KCCQ-CSS 11.4 vs 8.4, p=0.021; pVO2 0.64 vs -0.03, p=0.003). The findings were robust and consistent across key secondary endpoints, and the company will host a conference call on May 5 at 8:00 AM ET. Notably, there are no approved therapies for non-obstructive HCM, and aficamten is a cardiac myosin inhibitor in development, with MYQORZO approved for obstructive HCM.