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Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome
Preparing for FDA approval and commercial launch of tividenofusp alfa, Denali’s TransportVehicle™ (TV)-enabled investigational therapy for Hunter
About this update from Denali Therapeutics Inc.
[{"type":"text","content":"Preparing for FDA approval and commercial launch of tividenofusp alfa, Denali’s TransportVehicle™ (TV)-enabled investigational therapy for Hunter syndromeExpecting multiple clinical data readouts from pipeline programs including for Sanfilippo syndrome Type A (ETV:SGSH), granulin-related frontotemporal dementia (PTV:PGRN) and Parkinson’s disease (LRRK2 inhibitor)Planning for initiation of first-in-human clinical studies with TV-enabled therapeutics for Alzheimer’s disease (OTV:MAPT, ATV:Abeta) and Pompe disease (ETV:GAA)Continuing to strengthen leadership in transferrin receptor (TfR)-enabled and blood-brain barrier crossing therapeutics with continued advancement of enzyme, oligonucleotide and antibody programs SOUTH SAN FRANCISCO, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced key anticipated milestones and priorities for 2026 across its portfolio of investigational therapies for neurodegenerative diseases, lysosomal storage disorders and other serious diseases. Chief Executive Officer Ryan Watts, Ph.D., will highlight these priorities during a corporate presentation at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, at 1:30 p.m. PDT. “2026 is a defining year for Denali as we prepare to deliver our first TV-enabled medicine to patients,” said Dr. Watts. “We are on the cusp of launching tividenofusp alfa, which we believe will establish a new standard of care for people living with Hunter syndrome and mark the first commercial validation of our platform. In addition, we expect multiple clinical data readouts across our portfolio and plan to advance two TV-enabled programs into clinical studies for Alzheimer’s disease and a program for Pompe disease. As pioneers in TfR-enabled therapeutics, we are committed to advancing a new generation of transformative medicines with the potential to enhance and enable delivery of biotherapeutics throughout the whole body, including the brain.” 2026 Outlook Expected progress and key milestones across Denali’s portfolio of TV-enabled and small molecule programs in 2026 are summarized below. CLINICAL PROGRAMS Tividenofusp alfa (DNL310, ETV:IDS) for Hunter syndrome (MPS II) Denali is preparing for commercial launch in anticipation of a regulatory decision on the Biologics License Application (BLA) for tividenofusp alfa ...