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Denali Therapeutics Inc. is a biopharmaceutical firm, founded in 2013 and based in South San Francisco, California, which focuses on identifying and advancing treatments for neurodegenerative conditions within the United States. The company, initially known as SPR Pharma Inc. until its renaming in March 2015, possesses a robust development pipeline. This includes BIIB122/DNL151, a small molecule inhibitor targeting leucine-rich repeat kinase 2 (LRRK2), currently in Phase 1 and Phase 1b clinical trials for Parkinson's disease. Another candidate, DNL310, is progressing through Phase 1/2…

Denali Therapeutics gains FDA approval for Avlayah, but pipeline setbacks and partner exits raise fresh questions as key clinical programs continue.

SOUTH SAN FRANCISCO, Calif., July 09, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that co-founder and Chief Executive Officer Ryan Watts, Ph.D., will deliver the opening plenary address, titled “Accelerating the Discovery and Development of Medicines for Neurodegeneration,” at the Alzheimer's Association International Conference® (AAIC), taking place July 12-15 in London. Dr. Watts will discuss recent scientific advances and future opportunities including new insights in the biology of disease, the use of biomarkers for diagnosis and assessment of treatment effect, and the potential for therapeutics to cross the blood-brain barrier for enhanced delivery to the brain.

Denali Therapeutics surges on Avlayah???s FDA approval, PRV sale and pipeline progress, but partnership changes and trial setbacks remain in focus.

DNLI will gain $195M from selling its Rare Pediatric Disease PRV, adding non-dilutive capital to advance its clinical portfolio and growth plans.

SOUTH SAN FRANCISCO, Calif., June 18, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $195 million. The U.S. Food and Drug Administration (FDA) awarded the PRV to Denali following accelerated approval of the enzyme replacement therapy AVLAYAH™ (tividenofusp alfa-eknm) for the treatment of Hunter syndrome (mucopolysaccharidosis type II; MPS II) in March 2026. AVLAYAH is the first FDA-approved medicine in an emerging class of biotherapeutics designed to cross the blood-brain barrier via transferrin receptor (TfR)-mediated transport.