Cytokinetics said its aficamten (Myqorzo) met both Phase 3 co-primary endpoints in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in the pivotal ACACIA program. According to the company, the results showed statistically significant improvements from baseline to week 36 versus placebo in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and in maximal exercise performance. Aficamten was previously cleared by the FDA for obstructive HCM as Myqorzo in December, and the new nHCM dataset—if confirmed by regulators—could broaden the treatable population. Analysts expect the addressable market to expand materially if label expansion follows. The company’s communications point to a trial design that “played out exactly as drawn up,” reinforcing the data package being readied for subsequent regulatory steps.
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