Cytokinetics meets with FDA on aficamten drug application

Cytokinetics (NASDAQ: CYTK) participated in a late cycle meeting with the Food and Drug Administration on September 15, 2025, regarding its new drug application for aficamten in obstructive hypertrophic cardiomyopathy.

The company discussed its proposed risk evaluation and mitigation strategy program and anticipated post-marketing requirements for the drug during the meeting. Cytokinetics received the FDA's response to its proposed risk mitigation program and labeling for aficamten prior to the meeting.

The FDA target action date for the aficamten application remains December 26, 2025, under the Prescription Drug User Fee Act. Cytokinetics completed all good clinical practice inspections for aficamten and received communications from the FDA noting no observations. No good manufacturing practice inspections have been scheduled for the drug.

The company recently submitted responses to Day 120 questions from the Committee for Medicinal Products for Human Use at the European Medicines Agency regarding potential approval of aficamten in the European Union.

Separately, Cytokinetics announced it intends to draw the full $100 million available under Tranche 5 term loans from its development funding loan agreement with Royalty Pharma Development Funding on or about October 1, 2025. The company is entitled to access these funds until November 25, 2025.

You May Also Be Interested In

• Stripe, Advent In Talks To Buy Paypal - WSJ
• Waymo wins California approval to expand ride-hailing service
• Paramount Skydance clears global regulators for WBD deal, faces state AG suit