Cytokinetics Plunges 12.02% on FDA Review Extension

On May 2, 2025, Cytokinetics experienced a significant drop of 12.02% in pre-market trading, reflecting investor concerns and market reactions to recent developments.

Cytokinetics recently announced that the FDA has extended the review period for its heart drug aficamten. The extension, which pushes the decision date to December 26, 2025, is due to the FDA's need for additional time to evaluate the company's proposed Risk Evaluation and Mitigation Strategy (REMS). This extension is a standard three-month delay resulting from the submission of the REMS, which the FDA has classified as a Major Amendment to the New Drug Application (NDA).

Despite the extension, the FDA has not requested any additional clinical data or studies for aficamten. Cytokinetics remains prepared for potential approval and continues to work closely with regulatory authorities to address any outstanding issues. The company's focus on developing innovative treatments for cardiovascular diseases remains unchanged, and it is committed to advancing its pipeline of therapies.