Cytokinetics, Incorporated (NASDAQ: CYTK)

This lawsuit is for anyone who acquired securities in Cytokinetics, Incorporated (NASDAQ: CYTK) from December 27, 2023 through May 6, 2025.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by telling investors that the FDA was likely to approve the Company’s New Drug Application for aficamten when the Company knew that the FDA would not approve the NDA because the Company knowingly submitted a defective NDA.

On May 1, 2025, Cytokinetics disclosed that the FDA has extended the review period for its cardiac myosin inhibitor drug, aficamten, by three months, citing additional time required to review newly submitted Risk Evaluation and Mitigation Strategy (REMS). The Company further revealed that, “following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS.” On this news, the price of the Company’s stock dropped precipitously on unusually heavy trading volume. Then, on May 6, 2025, Cytokinetics admitted that it 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. On this news, the price of the Company’s stock again dropped precipitously on unusually heavy trading volume

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Cytokinetics, Incorporated (NASDAQ: CYTK) from December 27, 2023 through May 6, 2025 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.