A securities class action has been filed against Cytokinetics, Incorporated (CYTK) on behalf of all investors who purchased or otherwise acquired Cytokinetics common stock between December 27, 2023 through May 6, 2025. This case has been filed in the USDC – NDCA.
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 to the Company’s failure to submit a Risk Evaluation and Mitigation Strategy (“REMS”) that could delay the regulatory process. On May 6, 2025, during an earnings call, it was revealed that the Company had multiple pre-NDA meetings with the FDA discussing safety monitoring and risk mitigation but chose to submit the NDA without a REMS, relying on labeling and voluntary education materials. This confirmed defendants’ awareness of potential REMS requirements and their reckless decision to omit it from the initial submission, misleading investors about the regulatory timeline. As a result of defendants’ false and misleading statements, class members purchased Cytokinetics’ common stock at artificially inflated prices and suffered significant losses when the truth was revealed.