Cytokinetics(US:CYTK) Globenewswire·2025-10-31 20:01Core 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 affected investors between December 27, 2023, and May 6, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Cytokinetics made materially false and misleading statements regarding the expected timeline for FDA approval of aficamten, 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 significant 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]. Group 2: Investor Information - Investors who suffered losses in Cytokinetics during the specified timeframe have until November 17, 2025, to request to be appointed as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, and there is no obligation to participate [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].