Cytokinetics(US:CYTK) Prnewswire·2025-10-21 13:00Core 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]. Group 1: Lawsuit Details - The lawsuit seeks to recover losses for Cytokinetics investors affected by alleged securities fraud between December 27, 2023, and May 6, 2025 [1]. - Defendants allegedly made materially false statements regarding the expected approval timeline for the NDA for aficamten, claiming approval from the FDA in the second half of 2025 based on a September 26, 2025 PDUFA date [2]. - The complaint highlights that the company failed to disclose risks related to 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 but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [2]. Group 2: Next Steps for Investors - Investors who suffered losses in Cytokinetics during the relevant timeframe have until November 17, 2025, to request the Court to appoint them as lead plaintiff [3]. - Participation in the lawsuit does not require serving as a lead plaintiff, and there are no out-of-pocket costs for class members [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [4].