Cytokinetics, Incorporated

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, Cytokinetics’s stock price fell $5.57, or 12.9%, to close at $37.35 per share on May 2, 2025, thereby injuring investors.

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, Cytokinetics’s stock price fell $0.93, or 2.7%, to close at $33.04 per share on May 7, 2025, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Defendants had knowingly or recklessly omitted a REMS from the initial NDA submission, despite prior FDA discussions about safety and risk mitigation; (2) the subsequent REMS submission necessitated a three-month delay in the FDA’s process for potential approval; and (3) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.