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Cytokinetics Investors Face Nov. 17 Deadline in Securities Suit Over Aficamten FDA Disclosures

Plaintiff firms allege the company misled shareholders about approval timing by submitting its aficamten application without a REMS after prior FDA safety discussions.

Overview

  • A federal securities class action is pending in the Northern District of California as Seidman v. Cytokinetics, Inc., No. 25-cv-07923.
  • The putative class covers purchases of Cytokinetics stock from December 27, 2023 through May 6, 2025.
  • Complaints claim executives touted a September 26, 2025 PDUFA date and expected second‑half 2025 approval while failing to disclose that a REMS was omitted from the initial NDA.
  • Filings state the company revealed on May 6, 2025 that it held pre‑NDA meetings on safety and opted to rely on labeling and voluntary education instead of a REMS, and shares closed at $33.04 on May 7.
  • Multiple law firms are inviting motions to be lead plaintiff by November 17, 2025, and no class has been certified as the allegations remain contested.