Denali Therapeutics

DNLI

Market cap $3.65B

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.

Denali Therapeutics Inc. (DNLI) Presents at Jefferies Global Healthcare Conference 2026 Transcript

Denali Therapeutics (DNLI) maintains a "Strong Buy" rating following FDA Accelerated Approval of AVLAYAH for Hunter Syndrome and robust pipeline momentum. Company's DNL593 for FTD-GRN is differentiated by restoring both extracellular and lysosomal PGRN; phase 1/2 data readout expected by end of 2026. AVLAYAH's full approval depends on confirmatory COMPASS study results; commercial performance remains unproven post-April 2026 launch.

DNLI sinks after BIIB122 failed a mid-stage Parkinson's study, prompting Denali and Biogen to halt development in idiopathic cases.

Denali Therapeutics NASDAQ: DNLI is seeing early commercial interest for its first approved drug, AVLAYAH, following its March 24 accelerated approval for Hunter syndrome, Chief Operating Officer and Chief Financial Officer Alexander Schuth said at a Bank of America Securities conference.

Denali Therapeutics Inc. (DNLI) Presents at Bank of America Global Healthcare Conference 2026 Transcript