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Denali Therapeutics Announces FDA Acceptance, Priority Review of Biologics License Application For Tividenofusp Alfa For Hunter Syndrome; Sets PDUFA Date Of Jan. 5, 2026

Author: Benzinga Newsdesk | July 07, 2025 07:03am

FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approval
Tividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brain
Tividenofusp alfa leads company's broader TransportVehicle™-enabled pipeline

Posted In: DNLI