Cytokinetics Faces Class Action Over Alleged Misleading Drug Application Timeline

Robbins LLP is investigating allegations that Cytokinetics, Inc. (CYTK) misled investors about the timeline for its New Drug Application submission and approval process for aficamten. The class action alleges that defendants made false and misleading statements about the NDA submission and approval process, which affected the company's stock price. The investigation is focused on the period between December 27, 2023 and May 6, 2025.

September 12, 2025 — Robbins LLP has announced that it is investigating allegations that Cytokinetics, Inc. (CYTK) misled investors about the timeline for its New Drug Application (NDA) submission and approval process for aficamten. The class action lawsuit, filed on behalf of persons and entities who purchased or otherwise acquired CYTK securities between December 27, 2023, and May 6, 2025, alleges that defendants made false and misleading statements regarding the NDA submission and approval process, which affected the company's stock price.

According to the complaint, during the class period, 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. This information was revealed during an earnings call on May 6, 2025, when it was disclosed 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, misleading investors about the regulatory timeline Cytokinetics participates in FDA late cycle meeting for NDA for aficamten - SEC filing^[2].

As a result of these false and misleading statements, class members purchased CYTK common stock at artificially inflated prices and suffered significant losses when the truth was revealed. The investigation is focused on the period between December 27, 2023, and May 6, 2025.

Shareholders who wish to serve as lead plaintiff for the class must submit their papers with the court by November 17, 2025. The lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

Robbins LLP is a recognized leader in shareholder rights litigation and has been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. The firm operates on a contingency fee basis, meaning shareholders pay no fees or expenses.

For more information, visit Robbins LLP's website or contact the firm at (800) 350-6003.