zacks.com · 19 jun

Denali to Sell Priority Review Voucher for $195M Cash Boost

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

globenewswire.com · 18 jun

Denali Therapeutics Enters Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $195 Million

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.

seekingalpha.com · 5 jun

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

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

seekingalpha.com · 27 may

Denali Therapeutics: 'Strong Buy' On AVLAYAH Approval And End Of 2026 FTD-GRN Data

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.

zacks.com · 22 may

Denali Stock Dips as Biogen-Partnered Parkinson's Disease Study Fails

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

fool.com · 18 may

Hedge Fund Wagers $36 Million on Biotech Denali After First FDA Approval

This biotech develops therapies for neurodegenerative diseases, advancing a broad pipeline through strategic pharmaceutical partnerships.

marketbeat.com · 16 may

Denali Therapeutics Says AVLAYAH Launch Ahead of Expectations After Hunter Syndrome Approval

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.

seekingalpha.com · 12 may

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

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