Core Points - A class action securities lawsuit has been filed against Cytokinetics, Incorporated, alleging securities fraud affecting investors between December 27, 2023, and May 6, 2025 [2][3] - 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 [3] - The company allegedly failed to disclose significant risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS) from the NDA submission, which could delay the regulatory process [3] Case Details - Defendants represented that FDA approval for aficamten was expected in the second half of 2025, based on a PDUFA date of September 26, 2025 [3] - It was revealed during an earnings call on May 6, 2025, 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 [3] - As a result of these misleading statements, investors purchased Cytokinetics' common stock at inflated prices and incurred significant losses when the truth was disclosed [3] Next Steps - Investors who suffered losses in Cytokinetics during the relevant period have until November 17, 2025, to request to be appointed as lead plaintiff in the lawsuit [4] - Participation in the lawsuit does not require serving as a lead plaintiff, and there are no out-of-pocket costs for class members [4] Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [5]
Levi & Korsinsky Reminds Shareholders of a Lead Plaintiff Deadline of November 17, 2025 in Cytokinetics, Incorporated Lawsuit - CYTK