Cytokinetics(US:CYTK) Prnewswire·2025-10-09 22:40Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Cytokinetics, Incorporated due to misleading statements regarding the New Drug Application (NDA) for aficamten, which may have led to investor losses [1][2][4]. Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses in Cytokinetics between December 27, 2023, and May 6, 2025, to discuss their legal rights [1]. - A federal securities class action has been filed against Cytokinetics, with a deadline of November 17, 2025, for investors to seek the role of lead plaintiff [1]. Group 2: Misleading Statements - Defendants allegedly made materially false statements regarding the NDA submission timeline and FDA approval expectations for aficamten, indicating a PDUFA date of September 26, 2025, without disclosing risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS) [2]. - During an earnings call on May 6, 2025, it was revealed that Cytokinetics submitted the NDA without a REMS, despite prior discussions with the FDA about safety monitoring, which misled investors about the regulatory timeline [3]. Group 3: Impact on Investors - As a result of the misleading statements, class members purchased Cytokinetics' common stock at inflated prices and incurred significant losses when the truth was disclosed [4]. - The lead plaintiff in the class action will be the investor with the largest financial interest who is typical of class members, and any member can move to serve as lead plaintiff or remain an absent class member [5].