Cytokinetics(US:CYTK) Globenewswire·2025-10-23 20:18Core Viewpoint - A class action securities lawsuit has been filed against Cytokinetics, alleging securities fraud related to misleading statements about the New Drug Application (NDA) for aficamten, which may have led to significant investor losses [1][2]. Case Details - The lawsuit claims that Cytokinetics made materially false and misleading statements regarding the expected timeline for FDA approval of aficamten, specifically indicating approval in the second half of 2025 based on a September 26, 2025 PDUFA date [2]. - It is alleged that the company failed to disclose critical risks associated with not submitting a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [2]. - During an earnings call on May 6, 2025, it was revealed that the company had discussions with the FDA about safety monitoring and risk mitigation but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [2]. Next Steps - Investors who suffered losses in Cytokinetics during the specified period have until November 17, 2025, to request appointment as lead plaintiff, although participation does not require serving in this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Why Levi & Korsinsky - Levi & Korsinsky has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the U.S. [4].