Overview

• The lawsuit, filed in the U.S. District Court for the Northern District of California, covers purchasers of Cytokinetics stock from December 27, 2023 through May 6, 2025.
• Plaintiffs allege the company misled investors by projecting FDA approval in the second half of 2025 based on a September 26, 2025 PDUFA date for aficamten.
• The complaint claims Cytokinetics failed to disclose material risks tied to not including a Risk Evaluation and Mitigation Strategy with its NDA.
• Notices cite a May 6, 2025 earnings call stating the company held multiple pre-NDA meetings with the FDA on safety and risk mitigation and submitted the NDA without a REMS, relying on labeling and voluntary education.
• Bragar Eagel & Squire and Levi & Korsinsky announced the case and are recruiting investors, while Faruqi & Faruqi says it is investigating claims and reminding shareholders of the November 17 deadline.