Cytokinetics (CYTK) Faces Class Action Over Misleading Aficamten Claims  

A class action lawsuit was filed against Cytokinetics, Inc. (CYTK) on September 17, 2025. The plaintiffs (shareholders) alleged that they bought CYTK stock at artificially inflated prices between December 27, 2023, and May 6, 2025 (Class Period) and are now seeking compensation for their financial losses. Investors who bought Cytokinetics stock during that period can click here to learn about joining the lawsuit.

Cytokinetics is a specialty cardiovascular biopharmaceutical company with a robust pipeline of small-molecule muscle activators and inhibitors designed to treat diseases characterized by impaired muscle function. These include heart failure, hypertrophic cardiomyopathy (HCM), and various neuromuscular disorders.

The company’s claims about its lead drug candidate, Aficamten, particularly those related to its New Drug Application (NDA) and commercialization timeline, are at the heart of the current complaint.

Cytokinetics’ Misleading Claims

According to the lawsuit, Cytokinetics and its CEO (the Defendants) repeatedly made false and misleading public statements throughout the Class Period. In particular, they are accused of omitting truthful information about the submission of a Risk Evaluation and Mitigation Strategy (REMS) in association with the NDA, and the NDA approval, from SEC filings and related material.

In a press release filed at the beginning of the Class Period, the CEO said they finished 2023 well, helped by strong results from their SEQUOIA-HCM study, which are moving the company forward toward its new focus on specialty cardiology. The company was getting ready to submit Aficamten for regulatory approval, preparing for its commercial launch, and continuing Phase 3 trials in patients with two types of hypertrophic cardiomyopathy (oHCM and nHCM). They believe these trials would help prove that Aficamten can benefit a wider range of patients.

Later, in its August 8, 2024 press release, Cytokinetics said it plans to include a specific risk management plan for Aficamten as part of its ongoing NDA. The company had expected to finish submitting the rolling NDA by the third quarter of 2024.

Finally, in its December 2, 2024 press release, the CEO said that the FDA’s acceptance of the Aficamten application was an important step toward bringing their scientific work to patients with obstructive HCM.

However, subsequent events (detailed below) revealed that the defendants had failed to inform investors that Cytokinetics did not submit a Risk Evaluation and Mitigation Strategy (REMS) for the NDA that could delay the regulatory process.

Plaintiffs’ Arguments

The plaintiffs maintain that the defendants deceived investors by lying and withholding critical information about the company’s business and prospects during the Class Period. Importantly, the defendants allegedly misled investors regarding the timeline for the NDA submission and approval process for Aficamten.

After a series of partial disclosures, the information became clear during the Q1 earnings call held on May 6, 2025. The CEO acknowledged that the company had held several pre-NDA meetings with the FDA about safety monitoring and risk management but decided to submit the NDA without including a REMS report, relying instead on labeling and voluntary educational materials.

The complaint further claims that by making this admission, the CEO confirmed that both he and the company knew about the possible need for a REMS yet chose to exclude it from the original filing, thereby misleading investors about the regulatory timeline. Following the news, CYTK stock fell 7.4%.

To conclude, the defendants misled investors into believing that the company expected the FDA approval for its Aficamten NDA in the second half of 2025, based on a September 26, 2025, PDUFA date, and failed to disclose material risks related to its failure to submit a REMS that could delay the regulatory process. Despite these issues, CYTK stock has gained 28.2% year-to-date.