Cytokinetics Inc (CYTK) News & EventsCYTKNews & EventsCytokinetics Inc

Cytokinetics Presents ACACIA-HCM and MAPLE-HCM Results at ESC Congress

Cytokinetics announced that additional results from ACACIA-HCM and MAPLE-HCM were presented in a Late Breaking Clinical Session at the European Society of Cardiology, ESC, Congress 2026 in Munich, Germany and simultaneously published in Circulation and the Journal of the American College of Cardiology: Heart Failure, respectively. Key highlights: Additional Results from ACACIA-HCM Demonstrate Improvements in Cardiac Structure and Diastolic Function in Patients with Non-Obstructive HCM; New Analysis of MAPLE-HCM Finds Aficamten Outperformed Metoprolol Across Pre-Trial Treatment Groups in Patients with Obstructive HCM

U.S. Stock Futures Slightly Lower, Focus on Fed Policy Speech

Stock futures are slightly lower Friday after Thursday's AI-driven rally as attention turns to Federal Reserve Chair Kevin Warsh's first major policy speech at the Jackson Hole symposium. Investors are looking for clarity on the Fed's reaction to inflation that remains above its 2% target, a softer labor market and unusually high long-term Treasury yields. Markets are currently pricing about a 36% probability of a September rate hike.The Treasury market remains a major risk. Long-term yields have risen sharply in recent weeks, with the 30-year yield near levels last seen in 2007. Treasury Secretary Scott Bessent's expanded bond-buyback program has attempted to ease pressure at the long end of the curve, but investors remain concerned about inflation, government borrowing and the fiscal outlook.In pre-market trading, S&P 500 futures rose 0.08%, Nasdaq futures fell 0.13% and Dow futures rose 0.15%.Check out this morning's top movers from around Wall Street, compiled by The Fly.UP AFTER EARNINGS -Elasticup 24%Gapup 18%Affirmup 12%DOWN AFTER EARNINGS -Marvelldown 7%Minisodown 4%Rubrikdown 4%Autodeskdown 3%Chageedown 3%LOWER -PayPaldown 14% after Bloomberga consortium of Advent and Stripe are abandoning a pursuit of the companyCytokinetics (CYTK) down 2% after announcing the primary results from ACACIA-HCM, the Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy

Cytokinetics ACACIA-HCM Trial Results Show Significant Improvements

Cytokinetics announced the primary results from ACACIA-HCM, the Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy were presented in a Hot Line Session at the European Society of Cardiology Congress 2026 in Munich, Germany, and simultaneously published in The New England Journal of Medicine. ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and maximal exercise performancem or pVO2. Results for the dual primary endpoint analysis consistently favored aficamten across prespecified subgroups studied. Based on the positive results from ACACIA-HCM, Cytokinetics plans to submit a supplemental New Drug Application to the FDA for aficamten for the treatment of adult patients with symptomatic nHCM in the fourth quarter of 2026. The baseline characteristics of patients enrolled in ACACIA-HCM were well-matched between treatment groups and consistent with a symptomatic nHCM phenotype with substantial disease burden despite normal left ventricular ejection fraction. There were two pre-specified primary endpoints, KCCQ-CSS and pVO2, evaluated in parallel. For each endpoint, a p-value of 0.025 or less was considered statistically significant. Compared to placebo, treatment with aficamten demonstrated statistically significant improvements in both dual primary endpoints at 36 weeks. Improvements in KCCQ-CSS relative to placebo were noted beyond titration and throughout the treatment period in participants treated with aficamten, such that patients remaining on treatment at 72 weeks demonstrated a least square mean change from baseline in KCCQ-CSS of 7.0 points. Of note, following a washout of aficamten for four weeks, the KCCQ-CSS declined from the end of treatment for participants on aficamten to match that in the placebo group.