Cytokinetics(US:CYTK) Globenewswire·2025-10-20 16:43Core Viewpoint - A class action lawsuit has been filed against Cytokinetics, alleging securities fraud and unlawful business practices related to the company's New Drug Application for aficamten [2][4]. Group 1: Lawsuit Details - The class action lawsuit concerns whether Cytokinetics and certain officers or directors engaged in securities fraud or other unlawful business practices [2]. - Investors have until November 17, 2025, to request to be appointed as Lead Plaintiff if they purchased Cytokinetics securities during the Class Period [2]. Group 2: FDA Interaction and Stock Impact - On March 10, 2025, Cytokinetics disclosed that the FDA would not convene an advisory committee meeting for aficamten's NDA [4]. - The FDA extended the action date for aficamten's NDA from September 26, 2025, to December 26, 2025, due to the need for a Risk Evaluation and Mitigation Strategy (REMS) that was not included in the original NDA [4]. - Following the news, Cytokinetics' stock price fell by $5.57 per share (12.98%) to close at $37.35 on May 2, 2025 [5]. - On May 6, 2025, CEO Robert I. Blum acknowledged that the company had multiple pre-NDA meetings with the FDA but chose to submit the NDA without a REMS [5]. - After this acknowledgment, the stock price fell by $2.70 per share (7.36%) to close at $33.97 on May 6, 2025 [6].