The Gross Law Firm notifies investors that a class action has commenced in the United States District Court for the Northern District of California on behalf of shareholders of Cytokinetics, Incorporated who purchased common stock between December 27, 2023 and May 6, 2025.
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.
If you wish to choose counsel to represent you and the class, you must apply to be appointed lead plaintiff and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement for the class in the action. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in the respective securities during the class periods. Members of the class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. No class has yet been certified in the above action. Appointment as Lead Plaintiff is not required to partake in any recovery.
Shareholders have until November 17, 2025 to request that the court appoint them lead plaintiff.
To receive more information, please fill out the form.
