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Cytokinetics Faces Investor Class Action Over Aficamten REMS Disclosures as Lead-Plaintiff Deadline Nears

Plaintiffs allege undisclosed REMS issues delayed FDA action, harming shareholders.

Overview

  • Investors have until November 17, 2025 to seek appointment as lead plaintiff in the case covering trades from December 27, 2023 through May 6, 2025.
  • Glancy Prongay & Murray, Bronstein, Gewirtz & Grossman, and Faruqi & Faruqi are urging affected shareholders to contact them about the lawsuit.
  • Filings claim the company misrepresented the New Drug Application timeline for aficamten and pointed investors to a September 26, 2025 PDUFA date without disclosing key risks.
  • Cytokinetics disclosed on May 1, 2025 that the FDA extended aficamten’s review by three months to evaluate a newly submitted Risk Evaluation and Mitigation Strategy.
  • The complaint cites subsequent admissions about submitting the NDA without a REMS despite pre-NDA safety discussions and notes stock declines on May 2 and May 7, 2025.