Cytokinetics(US:CYTK) Prnewswire·2025-10-17 12:45Core Points - A class action securities lawsuit has been filed against Cytokinetics, Incorporated for alleged securities fraud affecting investors between December 27, 2023, and May 6, 2025 [1][2] - The lawsuit claims that Cytokinetics made materially false and misleading statements regarding the New Drug Application (NDA) submission and approval process for aficamten, particularly concerning the expected FDA approval timeline [2] - The company failed to disclose significant risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS) in its NDA submission, which could delay the regulatory process [2] Case Details - Defendants allegedly misrepresented the timeline for FDA approval, stating it would occur in the second half of 2025 based on a September 26, 2025 PDUFA date [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] - As a result of these misleading statements, investors purchased Cytokinetics' common stock at inflated prices and incurred significant losses when the truth was disclosed [2] Next Steps - Investors who suffered losses in Cytokinetics during the specified timeframe have until November 17, 2025, to request appointment 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] 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]