Denali Therapeutics announces key milestones, priorities for 2026

Denali Therapeutics (DNLI) announced key anticipated milestones and priorities for 2026 across its portfolio of investigational therapies for neurodegenerative diseases, lysosomal storage disorders and other serious diseases. 2026 Outlook: Denali is preparing for commercial launch in anticipation of a regulatory decision on the Biologics License Application for tividenofusp alfa under the U.S. Food and Drug Administration accelerated approval pathway with a Prescription Drug User Fee Act target action date of April 5, 2026; Denali will present initial clinical data from the fully enrolled, ongoing Phase 1/2 study of DNL126 at the 2026 WORLDSymposium; DNL628 is enabled by Denali’s Oligonucleotide TransportVehicle and is designed to cross the blood-brain barrier and reduce the tau protein by targeting the MAPT gene that encodes for tau; The Phase 1/2 study of TAK-594/DNL593 is ongoing with screening closed in Cohort B. Initial FTD-GRN patient data are expected in 2026. The program is being developed in collaboration with Takeda; Denali today announced that the U.S. FDA has lifted the clinical hold on the Investigational New Drug application for DNL952, and Denali will proceed with the Phase 1 study; The global Phase 2b LUMA study of BIIB122 completed enrollment of participants with early-stage Parkinson’s disease in 2025, with a clinical readout expected in 2026; The Phase 2 study of eclitasertib in participants with moderate to severe ulcerative colitis is expected to have results in the first half of 2026.