A decision from the FDA is expected on Sept. 26, 2025. A potential approval will allow Cytokinetics to capture market share as EWTX's candidate is still in clinical development. CYTK has also submitted a 120-day safety update to the FDA for the aficamten filing with an additional 10 months of safety data arising from FOREST-HCM, the open-label extension study of aficamten in patients with HCM. A similar filing is also currently under review in the EU and China.