Cytokinetics(US:CYTK) Globenewswire·2025-09-18 17:15Core 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 significant investor losses [4][6][8]. Group 1: Legal Investigation and Class Action - The firm is encouraging investors who suffered losses exceeding $75,000 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 [4]. - The lead plaintiff is defined as the investor with the largest financial interest in the relief sought by the class, who will oversee the litigation on behalf of the class members [9]. Group 2: Misleading Statements and Regulatory Issues - Defendants allegedly made materially false and misleading statements regarding the timeline for the NDA submission and approval process for aficamten, claiming expected FDA approval in the second half of 2025 [6]. - The company failed to disclose material risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [6]. - During an earnings call on May 6, 2025, it was revealed that Cytokinetics had multiple pre-NDA meetings with the FDA but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [7]. Group 3: Impact on Investors - As a result of the misleading statements, class members purchased Cytokinetics' common stock at artificially inflated prices and suffered significant losses when the truth was revealed [8]. - The firm is also encouraging anyone with information regarding Cytokinetics' conduct, including whistleblowers and former employees, to come forward [10].