SOUTH SAN FRANCISCO, Calif., Aug. 29, 2026

Cytokinetics, Incorporated announced additional clinical data for aficamten from the ACACIA-HCM and MAPLE-HCM Phase 3 studies, presented during a Late Breaking Clinical Trial Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. The company said the new findings expand the clinical evidence supporting aficamten across different forms of hypertrophic cardiomyopathy (HCM), including patients with symptomatic non-obstructive HCM and obstructive HCM. The ACACIA-HCM findings were simultaneously published in Circulation, while the MAPLE-HCM analysis appeared in the Journal of the American College of Cardiology: Heart Failure. The latest presentations add to Cytokinetics’ broader clinical-development program for aficamten as the company continues to evaluate the cardiac myosin inhibitor across the HCM spectrum.

Aficamten Data Expand HCM Development Program

Cytokinetics highlighted additional findings from ACACIA-HCM, a Phase 3 study evaluating aficamten in adults with symptomatic non-obstructive HCM (nHCM). According to the company, the new analysis extends the understanding of aficamten beyond exercise capacity and symptom outcomes by examining cardiac structure and diastolic function. The findings showed changes in measures associated with myocardial relaxation, early diastolic filling and cardiac remodeling during treatment. The company emphasized that these observations may help explain how cardiac myosin inhibition could provide functional benefits in nHCM even when patients do not have significant left ventricular outflow tract obstruction. This is particularly relevant because non-obstructive HCM remains an area with significant unmet treatment needs, and Cytokinetics is seeking to broaden the potential clinical role of aficamten beyond its established development in obstructive disease.

MAPLE-HCM Supports Consistent Aficamten Activity

At ESC Congress 2026, Cytokinetics also presented a post-hoc analysis from MAPLE-HCM, a Phase 3 study comparing aficamten with metoprolol in patients with symptomatic obstructive HCM. The company said the analysis evaluated whether treatment effects differed according to patients’ medical therapy before entering the study. Aficamten demonstrated a consistent effect across patients who had and had not previously received beta-blocker therapy, supporting the potential applicability of the treatment across different patient backgrounds. The findings add to the primary MAPLE-HCM results, in which aficamten demonstrated superiority over metoprolol for the study’s exercise-capacity endpoint. Cytokinetics said the analysis also showed consistent improvements across several secondary measures, including health status, functional class, LVOT obstruction and NT-proBNP, without identifying differences in the safety profile according to prior treatment.

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Cytokinetics Advances Aficamten Toward Broader Use

The ESC 2026 presentations represent another step in Cytokinetics’ strategy to develop aficamten across the HCM spectrum. Aficamten is a selective cardiac myosin inhibitor designed to reduce excessive cardiac contractility, with the potential to improve functional capacity and symptoms in patients with obstructive HCM. MYQORZO® (aficamten) is already approved in the United States, China, European Union and United Kingdom for adults with symptomatic obstructive HCM. Following the positive ACACIA-HCM results, Cytokinetics plans to submit a Supplemental New Drug Application in the fourth quarter of 2026 seeking expansion into non-obstructive HCM. The company is also evaluating aficamten in additional clinical settings, including the CEDAR-HCM pediatric study and the FOREST-HCM open-label extension. Cytokinetics continues to advance its broader cardiovascular pipeline, including investigational cardiac myosin programs targeting heart failure and other cardiac muscle disorders. The company said the latest ESC data strengthen the overall evidence base for aficamten and support continued development of the therapy as a potential treatment option for patients affected by different forms of HCM.

Source:Cytokinetics,press relese