Denali Therapeutics Inc., a biopharmaceutical company, discovers and develops therapeutic candidates for neurodegenerative diseases in the United States. The company is headquartered in South San Francisco, California.
| Revenue (TTM) | 0 |
| Gross Profit (TTM) | $-406.40M |
| EBITDA | $-531.76M |
| Operating Margin | 0.00% |
| Return on Equity | -49.60% |
| Return on Assets | -27.00% |
| Revenue/Share (TTM) | $0.00 |
| Book Value | $5.84 |
| Price-to-Book | 4.43 |
| Price-to-Sales (TTM) | 3643.65 |
| EV/Revenue | 2843.16 |
| EV/EBITDA | 86.48 |
| Quarterly Earnings Growth (YoY) | 0.00% |
| Quarterly Revenue Growth (YoY) | -100.00% |
| Shares Outstanding | $158.71M |
| Float | $144.23M |
| % Insiders | 9.16% |
| % Institutions | 100.22% |
Volatility is currently contracting
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 Inc. (DNLI) Presents at Bank of America Global Healthcare Conference 2026 Transcript
Denali narrows its Q1 loss and gains FDA approval for Avlayah, the first new Hunter syndrome treatment option in nearly 20 years.
DNLI secures FDA nod for Avlayah, a first-in-decades Hunter syndrome therapy, but pipeline risks and Takedas exit complicate the outlook.
DNLI's shares decline after Takeda exits DNL593 partnership, leaving Denali to fully control and fund the therapy as it advances studies and plans 2026 data release.
