Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome

Core Insights - Denali Therapeutics Inc. is poised for significant advancements in 2026, focusing on the launch of its first TV-enabled medicine, tividenofusp alfa, for Hunter syndrome, which is expected to set a new standard of care [2][4] - The company anticipates multiple clinical data readouts and plans to initiate clinical studies for Alzheimer's disease and Pompe disease, emphasizing its commitment to developing transformative medicines [2][7] Clinical Programs - Tividenofusp alfa (DNL310, ETV:IDS): Denali is preparing for a commercial launch pending FDA's decision on the Biologics License Application (BLA) with a target action date of April 5, 2026. The Phase 1/2 trial results were published in The New England Journal of Medicine [4][5] - DNL126 (ETV:SGSH): Initial clinical data from the ongoing Phase 1/2 study for Sanfilippo syndrome Type A will be presented at the 2026 WORLDSymposium [5] - TAK-594/DNL593 (PTV:PGRN): The ongoing Phase 1/2 study for frontotemporal dementia is expected to yield initial patient data in 2026 [6] - DNL628 (OTV:MAPT): This program targets Alzheimer's disease and is designed to cross the blood-brain barrier. The Phase 1b study has been approved and is set to begin [7][8] - DNL952 (ETV:GAA): The FDA has lifted the clinical hold on this program for Pompe disease, allowing the Phase 1 study to proceed [9] - BIIB122/DNL151: The Phase 2b LUMA study for Parkinson's disease completed enrollment in 2025, with results expected in 2026 [10] Financial Outlook - As of September 30, 2025, Denali had approximately $872.9 million in cash and equivalents. In December 2025, the company completed an equity financing of about $200 million and entered a royalty funding agreement with Royalty Pharma, potentially yielding up to $275 million based on future sales of tividenofusp alfa [14] Key Anticipated 2026 Milestones - Tividenofusp alfa: Expected US Accelerated Approval in the first half of 2026 [15] - DNL126: Phase 1/2 data presentation in the first half of 2026 [15] - DNL628: Initiation of Phase 1b study in the first half of 2026 [15] - DNL952: Initiation of Phase 1 study in the first half of 2026 [15] - DNL151/BIIB122: Phase 2b LUMA data expected in the first half of 2026 [15] - DNL126: Phase 3 study initiation in the second half of 2026 [15] - DNL593: Phase 1/2 data expected in the second half of 2026 [15]