Press Releases

May. 07 Denali Therapeutics : Quarterly Report for Quarter Ending March 31, 2026 (Form 10-Q) PU
May. 07 Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights GL
Apr. 03 Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN) GL
Mar. 25 Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II) GL
Feb. 26 Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights GL
Feb. 05 Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™ GL
Feb. 02 Denali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™ GL
Jan. 30 Denali Therapeutics Announces Data Presentations on Enzyme TransportVehicle Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium AQ
Jan. 29 Denali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™ GL
Jan. 06 Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome GL
Jan. 06 Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome AQ
Dec. 30 The New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics’ Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II) GL
Dec. 10 Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants GL
Dec. 09 Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants GL
Dec. 04 Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement GL
Nov. 06 Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights GL
Nov. 06 Denali Therapeutics Announces Board and Executive Leadership Updates GL
25-10-13 Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome) GL
25-08-11 Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights GL
25-07-07 Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II) GL
25-07-07 Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II) AQ
25-05-06 Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome GL
25-04-03 Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome and Positive Ongoing Interactions with FDA on DNL126 through START Program AQ
25-04-02 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 AQ
25-04-02 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 GL
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