Cytokinetics(US:CYTK) Globenewswire·2025-10-22 20:01Core Viewpoint - Cytokinetics, Incorporated is facing a class action lawsuit due to allegations of misleading statements regarding the New Drug Application (NDA) submission and approval process for aficamten, which has led to significant losses for investors [3][4]. Summary by Sections Allegations - The complaint claims that Cytokinetics made materially false and misleading statements about the expected timeline for FDA approval of aficamten, initially projected for the second half of 2025 based on a PDUFA date of September 26, 2025 [3]. - It is alleged that the company failed to disclose risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [3]. - During an earnings call on May 6, 2025, it was revealed that the company had discussions with the FDA regarding safety monitoring but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [3]. Impact on Shareholders - As a result of the misleading statements, shareholders purchased Cytokinetics' common stock at artificially inflated prices and experienced significant losses when the truth was disclosed [3]. Class Action Details - The class period for the lawsuit is from December 27, 2023, to May 6, 2025, with a deadline for shareholders to register for the class action set for November 17, 2025 [4]. - Shareholders who register will receive updates on the case's status and can participate without any cost or obligation [4]. Law Firm Information - The Gross Law Firm, a nationally recognized class action law firm, is representing the shareholders and aims to protect investors' rights against deceit and fraud [5].