Cytokinetics(US:CYTK) Globenewswire·2025-09-22 19:42Core Viewpoint - Cytokinetics is facing a class action securities lawsuit due to alleged securities fraud related to the New Drug Application (NDA) for aficamten, which misled investors about the regulatory timeline and approval process [1][2]. Group 1: Lawsuit Details - The lawsuit seeks to recover losses for Cytokinetics investors affected by false statements regarding the NDA submission and approval timeline for aficamten between December 27, 2023, and May 6, 2025 [1]. - Defendants allegedly misrepresented the expected FDA approval timeline for aficamten, claiming it would occur in the second half of 2025, while failing to disclose risks associated with not submitting a Risk Evaluation and Mitigation Strategy (REMS) [2]. - The revelation during a May 6, 2025 earnings call indicated that the company had discussions with the FDA about safety monitoring but chose to submit the NDA without a REMS, leading to significant losses for investors when the truth was disclosed [2]. Group 2: Next Steps for Investors - Investors who suffered losses in Cytokinetics during the relevant period have until November 17, 2025, to request appointment 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, with no obligation to participate [3]. Group 3: Firm Background - Levi & Korsinsky has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years and being recognized as one of the top securities litigation firms in the United States [4].