Tividenofusp alfa PDUFA Date (Denali Therapeutics)
FDA PDUFA decision date for Tividenofusp alfa is April 5, 2026. Developed by Denali Therapeutics. Indication: Hunter syndrome (MPS II) — CNS-penetrant enzyme replacement. Current status: Approved.
Indication
Hunter syndrome (MPS II) — CNS-penetrant enzyme replacement
Notes
First CNS-penetrant therapy for Hunter syndrome. Breakthrough therapy.
Regulatory details
- Company: Denali Therapeutics
- Therapeutic area: Rare Disease / Neurometabolic
- Application type: BLA
- Review type: Priority
- PDUFA date: 2026-04-05
- Outcome: Approved