FDA accepts Denali's BLA for tividenofusp alfa with Priority Review; PDUFA Jan 5, 2026

Denali Therapeutics Inc.

FDA grants Priority Review for BLA seeking accelerated approval of tividenofusp alfa for Hunter syndrome (MPS II).
PDUFA target action date set for January 5, 2026.
Tividenofusp alfa is designed to deliver IDS enzyme across the blood-brain barrier using TransportVehicle platform.
BLA supported by Phase 1/2 data from 47 participants; ongoing Phase 2/3 COMPASS study for global approvals.
If approved, would be first new enzyme replacement therapy for Hunter syndrome in nearly two decades.

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