Cytokinetics(US:CYTK) Globenewswire·2025-10-20 20:20Core 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 NDA submission timeline and FDA approval expectations, claiming approval 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]. Group 2: Impact on Investors - On May 6, 2025, it was revealed during an earnings call that Cytokinetics had multiple pre-NDA meetings with the FDA but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [2]. - As a result of the misleading statements, investors purchased Cytokinetics' common stock at inflated prices and suffered significant losses when the truth was disclosed [2]. Group 3: Next Steps for Investors - Investors who suffered losses during the relevant timeframe have until November 17, 2025, to request to be appointed 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]. Group 4: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has extensive expertise in complex securities litigation [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].