Cytokinetics, Incorporated, a biopharmaceutical company, is facing a class action lawsuit that could have significant implications for its shareholders. The lawsuit alleges that the company misled investors about the timeline for the approval of its New Drug Application (NDA) for aficamten, a promising new treatment. Shareholders who invested in Cytokinetics between December 27, 2023, and May 6, 2025, are seeking to recover losses incurred due to what they claim was securities fraud.
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The crux of the case lies in the company’s handling of the NDA process. According to the complaint, Cytokinetics assured investors that they anticipated FDA approval for aficamten in the latter half of 2025, based on a September 26, 2025, PDUFA date. However, they failed to disclose crucial risks associated with not submitting a Risk Evaluation and Mitigation Strategy (REMS), a necessary component for regulatory approval. This omission, the lawsuit claims, misled investors about the true timeline and risks involved.
The situation came to light on May 6, 2025, during an earnings call, where it was revealed that Cytokinetics had engaged in multiple pre-NDA discussions with the FDA about safety and risk mitigation. Despite this, they proceeded with the NDA submission without a REMS, opting instead for labeling and voluntary education materials. This decision, now under scrutiny, is said to have inflated the company’s stock prices artificially, leading to significant financial losses for shareholders when the truth emerged.
For those who have suffered losses in Cytokinetics stock during the specified period, there is an opportunity to seek recovery. Shareholders, even those who still hold their shares, are encouraged to visit the following link to learn more about their rights: [https://zlk.com/pslra-1/cytokinetics-incorporated-lawsuit-submission-form-2?wire=18](https://zlk.com/pslra-1/cytokinetics-incorporated-lawsuit-submission-form-2?wire=18). Participation comes at no cost or obligation.
Levi & Korsinsky LLP, the firm spearheading this lawsuit, has a formidable reputation in securities litigation. With over two decades of experience and a track record of securing hundreds of millions for shareholders, they are well-equipped to handle this complex case. The firm has been consistently recognized as one of the top securities litigation firms in the United States, making them a strong advocate for investors.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 17th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171