Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights

Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on trackDNL126 Phase 1/2 study enrollment completed, supporting an accelerated approval path in MPS IIIATwo new regulatory applications submitted to initiate clinical studies with DNL628 (OTV:MAPT) for Alzheimer’s disease and DNL952 (ETV:GAA) for Pompe diseaseTim Van Hauwermeiren, CEO of argenx, to join Denali's Board of DirectorsCarole Ho, M.D., Chief Me ...