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Noticias de CYTK
Eventos de CYTK
Cytokinetics Presents ACACIA-HCM Data at HFSA Meeting
Cytokinetics announced that additional data from ACACIA-HCM were presented at the Heart Failure Society of America, or HFSA, annual scientific meeting in Phoenix, Arizona. Data from a prespecified analysis of comprehensive exercise performance from ACACIA-HCM were presented in a late breaking clinical trial presentation. This analysis examined the effect of aficamten on multiple exercise parameters using the novel 2026 Boston Exercise Aggregate Physiologic Response Score, or BEAP-RS. The score captures outputs from five individual domains, ranging from submaximal exercise through to recovery, and generates a composite of global exercise performance. At 36 weeks, treatment with aficamten significantly improved BEAP-RS compared to placebo, with improvements in individual exercise and recovery measures across all five domains. Improvement in BEAP-RS correlated significantly with improvements in health status measured by both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, or KCCQ-CSS, and New York Heart Association, or NYHA, Functional Class, as well as the cardiac biomarker NT-proBNP. This analysis provides a greater understanding of the complete impact of aficamten on exercise capacity in patients with non-obstructive HCM. Data from a responder analysis of ACACIA-HCM evaluating the global efficacy of aficamten in patients with symptomatic nHCM were presented in a late breaking clinical trial presentation. The results were published in Circulation in August. The analysis assessed clinical improvements across five key domains. At 36 weeks, a greater proportion of patients treated with aficamten demonstrated a clinically meaningful response compared to placebo in all five domains, with statistically significant improvements in four domains: relief of limiting symptoms, decrease in left atrial volume index, or LAVI, increase in septal e' velocity and greater than or equal to 50% reduction in NT-proBNP. An increase in peak VO2 of at least 0.5 mL/kg/min was observed in 45% of patients on aficamten compared to 37% on placebo. Overall, 53% of patients on aficamten demonstrated a clinical response in three or more domains compared to only 13% of patients on placebo. These data place the primary results into clinical context and underscore the opportunity to impact several aspects of disease burden by addressing the underlying pathobiology in patients living with symptomatic nHCM. Data related to dose titration and the safety profile of aficamten in ACACIA-HCM were also presented. At the end of the titration period, 80.7% of patients were on 15 or 20 mg. Dose titration led to predictable, dose-proportional changes in plasma concentration of aficamten and reductions in left ventricular ejection fraction, or LVEF, which then remained stable from Week 8 through Week 36. LVEF less than50% occurred in 27 patients taking aficamten and in two patients taking placebo. The only patient characteristics associated with LVEF less than 50% were lower baseline LVEF and permanent atrial fibrillation. As previously reported, two participants on aficamten experienced a serious adverse event, or SAE, of heart failure associated with LVEF less than 50%. Ten additional patients on aficamten had SAEs of heart failure not associated with LVEF less than 50%, for a total of 12 patients compared to three patients on placebo. All heart failure events in patients treated with aficamten occurred during dose titration or prior to Week 12, often following a precipitating event such as rapid atrial fibrillation or infection, and responded to typical medical therapy such as diuretics. Overall, these data suggest that, in ACACIA-HCM, titration of aficamten to the maximum tolerated dose based on LVEF alone was generally well tolerated in the great majority of patients with nHCM.
Cytokinetics Launches Observational Study for Myqorzo
Cytokinetics announced the start of ASPEN-HCM, a prospective, multicenter, observational real-world study evaluating Myqorzo in adult patients with symptomatic obstructive hypertrophic cardiomyopathy. "We are pleased to announce the start of ASPEN-HCM, marking an important next step in our ongoing commitment to hypertrophic cardiomyopathy research," said Sanatan Shreay, Ph.D., Cytokinetics' Executive Director, Head of Health Economics and Outcomes Research. "The clinical trials we conducted of Myqorzo provided strong evidence supporting its approval. Now, this study will build on that foundation by generating valuable real-world insights that can help inform clinical decision-making and support clinicians in their everyday practices."
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.
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