Full Press Release Details
NEW YORK, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Cytokinetics, Incorporated ("Cytokinetics" or the "Company") (NASDAQ: CYTK) of a class action securities lawsuit.
CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Cytokinetics investors who were adversely affected by alleged securities fraud between December 27, 2023 and May 6, 2025. Follow the link below to get more information and be contacted by a member of our team:
CYTK investors may also contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500.
CASE DETAILS: According to the complaint, defendants made materially false and misleading statements regarding the timeline for the New Drug Application (“NDA”) submission and approval process for aficamten. Specifically, defendants represented that the Company expected approval from the U.S. Food and Drug Administration (“FDA”) for its NDA for aficamten in the second half of 2025, based on a September 26, 2025 PDUFA date, and failed to disclose material risks related to the Company’s failure to submit a Risk Evaluation and Mitigation Strategy (“REMS”) that could delay the regulatory process. On May 6, 2025, during an earnings call, it was revealed that the Company had multiple pre-NDA meetings with the FDA discussing safety monitoring and risk mitigation but chose to submit the NDA without a REMS, relying on labeling and voluntary education materials. This confirmed defendants’ awareness of potential REMS requirements and their reckless decision to omit it from the initial submission, misleading investors about the regulatory timeline. As a result of defendants’ false and misleading statements, class members purchased Cytokinetics’ common stock at artificially inflated prices and suffered significant losses when the truth was revealed.
WHAT'S NEXT? If you suffered a loss in Cytokinetics during the relevant time frame, you have until November 17, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.
NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate.
WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
33 Whitehall Street, 17th Floor