Press Releases

Date Description View
05/06/25

Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome

04/02/25

Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FDA on DNL126 Through START Program

02/27/25

Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights

02/06/25

Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa

01/30/25

Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™

01/13/25

Denali Therapeutics Announces Key Anticipated 2025 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases

01/08/25

Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)

01/06/25

Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial