According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements regarding the timeline for the New Drug Application (“NDA”) submission and approval process for aficamten. Specifically, defendants represented that Cytokinetics 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 Prescription Drug User Fee Act (“PDUFA”) date, and failed to disclose material risks related to Cytokinetics’ failure to submit a Risk Evaluation and Mitigation Strategy (“REMS”) that could delay the regulatory process.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
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