Cytokinetics reports Q2 2026 results, ACACIA-HCM hits both primary endpoints

Cytokinetics said it had announced positive topline results from ACACIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM)¹. The trial met both dual primary endpoints, showing statistically significant improvements from baseline to Week 36 in both the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and peak VO2 exercise performance¹, with statistically significant improvements versus placebo also seen in key secondary endpoints¹. On safety, no new safety signals were identified, though LVEF below 50% occurred in 10% of aficamten patients versus 1% on placebo, treatment interruptions for LVEF below 40% were rare, and two aficamten patients had a serious adverse event of heart failure tied to LVEF under 50%¹.

Full data will be presented at ESC in August, and the company expects to file a supplemental NDA for nHCM in the fourth quarter of 2026¹. Other pipeline updates: the Japan cohort of ACACIA-HCM continues, with trial conduct expected to complete in the third quarter of 2026¹, and Bayer's CAMELLIA-HCM trial in Japanese oHCM patients is also expected to complete conduct in Q3 2026¹. Enrollment in the adolescent cohort of CEDAR-HCM was recently completed¹.

On the commercial side, MYQORZO (aficamten) generated net product revenue of $25 million¹ and was prescribed by over 700 unique healthcare providers, with approximately 1,500 patients dispensed the drug and over 80% of patients on paid prescription as of June 30, 2026¹. The drug was granted UK marketing authorization by the MHRA, and NICE recommended it for use in England and Wales¹; regulatory filings are also under review in Canada and Switzerland¹.

The company reported approximately $1.7 billion in cash, cash equivalents and investments as of June 30, 2026, up from $1.1 billion at March 31, 2026¹, following a public stock offering of 11,338,028 shares at $71.00 per share that generated net proceeds of approximately $760.1 million¹. Cytokinetics also raised its 2026 spending guidance, saying the GAAP combined R&D and SG&A expense range increased to $860 million to $890 million from a prior $830 million to $870 million¹, an increase the company attributed to commercial readiness investments prompted by the positive ACACIA-HCM results to support a potential 2027 launch of MYQORZO in nHCM¹.