DNLI

Denali Therapeutics (DNLI) is transitioning from a neuroscience platform to a commercial biotech with AVLAYAH, its FDA-approved rare-disease therapy. AVLAYAH's Q2 revenue of $3.6M is projected to triple in Q3, reflecting accelerating patient uptake and payer coverage progress. DNLI's TransportVehicle platform underpins a pipeline spanning enzymes, antibodies, and oligonucleotides, targeting both rare and large neurodegenerative markets.

Denali Therapeutics narrows Q2 loss as Avlayah sales top estimates, with strong launch traction and pipeline updates shaping its outlook.

Denali Therapeutics Inc. (DNLI) Q2 2026 Earnings Call Transcript

SOUTH SAN FRANCISCO, Calif., July 27, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that it will report financial results and business highlights for the second quarter ended June 30, 2026, on Thursday, August 6, 2026.

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