Denali Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for neurological and lysosomal storage disorders. Denali's core innovation is its proprietary TransportVehicle (TV) platform, which is designed to deliver large molecule biotherapeutics — enzymes, antibodies, and oligonucleotides — across the blood-brain barrier (BBB) via intravenous administration. The platform works by engineering a modified Fc antibody domain that binds to receptors on the BBB, enabling receptor-mediated transcytosis into the brain. Denali's lead product, tividenofusp alfa, is an enzyme replacement therapy (ERT) for Hunter syndrome (MPS II) that uses the TV platform to treat both the neurological and physical manifestations of the disease — something the current standard of care cannot do. A BLA is under FDA review with a PDUFA date of April 2026. Denali has no approved products yet, and current revenue comes from collaboration agreements with Biogen, Takeda, and Sanofi, which fund portions of clinical development in exchange for co-commercialization rights and milestones. Denali's strategy is to launch tividenofusp alfa first, build a commercial organization around rare disease ERTs, and use that revenue base to fund development of additional TV-enabled programs in Pompe disease, Sanfilippo syndrome, Alzheimer's, and Parkinson's disease. For larger indications like Alzheimer's, Denali expects to rely on strategic partnerships rather than independent commercialization.