Key facts: Cytokinetics' NDA review delayed; class action lawsuit filed
TradingView
Cytokinetics faces an FDA review delay for aficamten and a class action lawsuit alleging securities fraud.Summary
Cytokinetics' New Drug Application (NDA) for aficamten has experienced a delay in review by the FDA. The review will no longer be assessed by an advisory committee, and the action date has been extended to December 26, 2025, due to the absence of a Risk Evaluation and Mitigation Strategy (REMS). Separately, a class action lawsuit has been filed against Cytokinetics, alleging securities fraud impacting investors who purchased stock between December 27, 2023, and May 6, 2025. The lawsuit was announced on October 20, 2025.
(Source：TradingView)