Cytokinetics, Incorporated

Case Overview
45 Days Left to Seek Lead Plaintiff
Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 11/17/2025 |
Status: | Status: Investigating |
Company Name: | Company Name: Cytokinetics, Incorporated |
Court: | Court: Northern District of California |
Case Number: | Case Number: 3:25cv07923 |
Class Period: | Class Period: 12/27/2023 - 05/06/2025 |
Ticker: | Ticker: CYTK |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
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.
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.
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.