Accessibility StatementSkip Navigation CASE DETAILS: According to the complaint, defendants made materially false and misleading statements regarding the timeline for the New Drug Application ("NDA") submission and approval process for aficamten. Specifically, defendants represented that the Company expected approval from the U.S. Food and Drug Administration ("FDA") for its NDA for aficamten in the second half of 2025, based on a September 26, 2025 PDUFA date, and failed to disclose material risks related ...