Aficamten PDUFA Date (Cytokinetics)
FDA PDUFA decision date for Aficamten is December 26, 2025. Developed by Cytokinetics. Indication: Obstructive hypertrophic cardiomyopathy (oHCM). Current status: Approved.
Indication
Obstructive hypertrophic cardiomyopathy (oHCM)
Regulatory details
- Company: Cytokinetics
- Therapeutic area: Rare Disease / Cardiology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2025-12-26
- Outcome: Approved