Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage diseaseFirst FDA-approved medicine in emerging new class of biotherapeutics that leverage transferrin receptor to cross blood-brain barrierDenali's first medicine enabled by its TransportVehicle™ platform designed to deliver biotherapeutics to whole body, including brainRare Pediatric Disease Priority Review Voucher (PRV) awarded in connection with FDA approvalDenali to host conference call and webcast today at 12:30 p.m. Eastern time SOUTH SAN FRANCISCO, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced the U.S. Food and Drug Adm
