Cytokinetics(US:CYTK) Prnewswire·2025-11-11 13:45Core 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 multiple pre-NDA meetings with the FDA but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [2]. Group 2: Investor Information - Investors who suffered losses during the relevant time frame have until November 17, 2025, to request the Court to appoint them as lead plaintiff, although participation does not require serving as a lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, with no obligation to participate [3]. Group 3: Legal Firm Background - Levi & Korsinsky, LLP 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 United States [4].