DNL921 (ATV:Abeta)

July 9, 2026: Denali Therapeutics Inc. (NASDAQ: DNLI) announced that co-founder/CEO Ryan Watts, Ph.D., will deliver the opening plenary at the Alzheimer’s Association International Conference (AAIC) in London (July 12–15, 2026), speaking on accelerating neurodegeneration drug discovery, including biomarkers and blood-brain barrier (BBB) delivery.

Regulatory/approval update: Denali said it received FDA accelerated approval in March 2026 for AVLAYAH (tividenofusp alfa-eknm), an enzyme replacement therapy for neurologic manifestations of Hunter syndrome (MPS II) in presymptomatic or symptomatic pediatric patients ≥5 kg prior to advanced neurologic impairment; it is described as the first FDA-approved biologic specifically designed to cross the BBB.

Pipeline catalysts:

• DNL628 (OTV:MAPT; tau/MAPT antisense oligonucleotide): First patients in a Phase 1b study were dosed in 1H26; clinical safety and biomarker proof-of-concept data are expected in 2027.
• DNL921 (ATV:Abeta; anti-amyloid antibody): A Clinical Trial Application (CTA) was submitted in 1H26; pending CTA approval, Denali expects to initiate a Phase 1/1b trial, with potential safety and biomarker proof-of-concept data in 2027. Preclinical work cited suggests improved brain distribution and reduced ARIA risk versus conventional anti-amyloid antibodies.