Overview

A class action lawsuit has been filed against Cytokinetics, Incorporated (“Cytokinetics” or the “Company”) and certain of the Company’s former senior executive officers alleging violations of the federal securities laws. The Company’s common stock traded on the NASDAQ Stock Market (the “NASDAQ”) under the symbol “CYTK.”

The Cytokinetics class action lawsuit was brought on behalf of all persons and entities who purchased or otherwise acquired Cytokinetics common stock between December 27, 2023 and May 6, 2025, both dates inclusive, (the “Class Period”).

Cytokinetics is a biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised. The Company’s research and development efforts are directed toward addressing serious unmet medical needs in cardiovascular and neuromuscular diseases.

Cytokinetics’ lead drug candidate, aficamten, is a cardiac myosin inhibitor designed to treat obstructive hypertrophic cardiomyopathy (“oHCM”), a condition where the heart muscle thickens, leading to obstructed blood flow and symptoms such as shortness of breath, chest pain, and fatigue. Aficamten aims to reduce cardiac muscle contractility, thereby improving blood flow and alleviating symptoms.

The lawsuit alleges that Defendants misled investors about the timeline and likelihood of FDA approval for Cytokinetics’ New Drug Application (“NDA”) for aficamten, a treatment for hypertrophic cardiomyopathy. Defendants repeatedly assured investors that approval was expected in the second half of 2025 based on a September 26, 2025 PDUFA date, while failing to disclose material risks related to the Company’s decision not to include a Risk Evaluation and Mitigation Strategy (“REMS”) in its original submission.

According to the lawsuit, these misrepresentations began after Cytokinetics announced positive Phase 3 results in December 2023, which it used to bolster investor confidence in its regulatory readiness. Defendants continued to emphasize their progress toward FDA approval in press releases and earnings calls, while concealing the fact that safety monitoring and risk mitigation requirements had been raised in pre-NDA discussions with the FDA.

The truth began to emerge on March 10, 2025, when the Company disclosed that the FDA would not convene an advisory committee to review the NDA. Further revelations came on May 1, 2025, when Cytokinetics announced that the FDA had extended the PDUFA date by three months to December 26, 2025, because the Company belatedly submitted a REMS at the FDA’s request. On May 6, 2025, CEO Robert Blum admitted that Cytokinetics had deliberately chosen not to include a REMS in the initial NDA, relying instead on labeling and voluntary education, despite prior FDA discussions on risk management.

As a result, the lawsuit alleges, investors were misled into believing approval was on track, purchased Cytokinetics’ stock at artificially inflated prices, and suffered significant losses when the Company disclosed the regulatory delays.

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If you purchased or otherwise acquired Cytokinetics common stock between December 27, 2023 and May 6, 2025, both dates inclusive, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as lead plaintiff in the Cytokinetics class action lawsuit is November 17, 2025.