Posted by Michael Wonder on 08 Jul 2025
Denali Therapeutics announces FDA acceptance and priority review of biologics license application for tividenofusp alfa for Hunter syndrome
7 July 2025 - FDA assigns PDUFA target action date of 5 January 2026, for decision on accelerated approval.
Denali Therapeutics today announced that the US FDA has accepted for review the biologics license application seeking accelerated approval for tividenofusp alfa for the treatment of Hunter syndrome (mucopolysaccharidoses type II, or MPS II).
