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PDUFA Date

PDUFA Date: tividenofusp alfa

April 5, 2026
Company
Denali Therapeutics Inc. (DNLI)
Drug
tividenofusp alfa
Indication
Hunter syndrome in January 2019

Other upcoming events for DNLI

Phase 3 ReadoutPhase 3 Topline: An Open-Label Extension to Investigate the Long-Term Safety, Tolerability, and Efficacy of DNL310 in
Jun 1, 2027
Phase 3 ReadoutPhase 3 Topline: A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tiv
Dec 1, 2027

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DNLI OverviewPDUFA DatesPhase 3 Readouts
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