Press Releases

Date Description View
11/06/25

Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights

11/06/25

Denali Therapeutics Announces Board and Executive Leadership Updates

10/13/25

Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)

08/11/25

Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights

07/07/25

Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II)

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™