Aficamten - (ACACIA-HCM)

August 6, 2026: Cytokinetics (NASDAQ: CYTK) reported Q2 2026 results and pipeline updates centered on MYQORZO (aficamten). For symptomatic non-obstructive HCM, the pivotal Phase 3 ACACIA-HCM trial showed positive topline results, meeting both dual primary endpoints with statistically significant improvements from baseline to Week 36 in KCCQ Clinical Summary Score and peak VO2; key secondary endpoints also improved versus placebo. No new safety signals were reported; LVEF <50% occurred in 10% on aficamten vs 1% on placebo, with rare treatment interruptions due to LVEF <40%, and two serious heart failure adverse events associated with LVEF <50%. Full ACACIA-HCM results will be presented in a Hot Line session at ESC in August 2026, and Cytokinetics expects to submit a supplemental NDA for nHCM in Q4 2026.

For commercial/regulatory status in obstructive HCM, MYQORZO generated $25.3 million in Q2 net product revenue, launched in Germany, was approved in the UK, received reimbursement approval in the Netherlands effective August 1, and remains under review in Canada, Switzerland, Hong Kong, and Taiwan; Taiwan granted priority review.

Other programs: omecamtiv mecarbil’s Phase 3 COMET-HF continues enrollment through 2026; ulacamten’s Phase 2 AMBER-HFpEF Cohort 1 is ongoing with enrollment completion expected in 2H 2026; CK-089 entered a second Phase 1 SAD study.