Cytokinetics Presents New Data Related to Aficamten at the European Society of Cardiology Congress 2025

Additional Data from MAPLE-HCM Shows Aficamten Improves Cardiac Structure and Function Compared to Metoprolol; Simultaneous Publication in the Journal of the American College of Cardiology

New Analysis Shows Annual Incidence Rate of Atrial Fibrillation with Aficamten is 1.5%, Consistent with Expected Rates in Prediction Model of Patients with HCM; Simultaneous Publication in Heart Rhythm

Longer-Term Data Presented Consistent with Previously Reported Safety Profile of Aficamten

Company to Host Investor Event and Webcast Tuesday September 2, 2025, at 8:30 AM Eastern Time

SOUTH SAN FRANCISCO, Calif., Aug. 31, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data related to aficamten were presented at the European Society of Cardiology Congress 2025 in Madrid, Spain, including a pre-specified analysis of the effect of aficamten on cardiac structure and function from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), which was simultaneously published in the Journal of the American College of Cardiology1, as well as a Late Breaking Clinical Science presentation related to the incidence and impact of atrial fibrillation (AF) associated with aficamten, which was simultaneously published in Heart Rhythm.2

“The echocardiographic results from MAPLE-HCM elaborate on the superiority of aficamten compared to the current standard-of-care metoprolol as was previously reported in the primary efficacy analyses,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “The additional data presented at the ESC Congress 2025 continue to strengthen the evidence base supporting the overall safety profile of aficamten, including as has been observed with a real-world dosing strategy.”

Aficamten is an investigational drug candidate currently under regulatory review in the U.S.; the Food and Drug Administration (FDA) is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025.

Additional Analysis from MAPLE-HCM Assesses Effect of Aficamten Compared to Metoprolol on Cardiac Structure and Function

Dr. Sheila Hegde, M.D., M.P.H., Assistant Professor, UT Southwestern Medical Center, Dallas, TX, Affiliate Faculty, Brigham and Women's Hospital, Boston, MA, presented a pre-specified echocardiographic analysis assessing the effect of treatment with aficamten relative to metoprolol on cardiac structure and function from MAPLE-HCM.

In addition to primary results of MAPLE-HCM presented by Dr. Garcia Pavia at the European Society of Cardiology Congress 2025, aficamten was also shown to be superior to metoprolol at improving measures of diastolic function and reducing the likelihood of mitral valve systolic anterior motion (SAM) and mitral valve leaflet-septal contact, the primary contributor to left ventricular outflow tract (LVOT) obstruction (Figure 1) (all p