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) | $21.38M |
| Gross Profit (TTM) | $-392.20M |
| EBITDA | $-514.00M |
| Operating Margin | -709.00% |
| Return on Equity | -33.90% |
| Return on Assets | -28.70% |
| Revenue/Share (TTM) | $0.12 |
| Book Value | $5.78 |
| Price-to-Book | 3.62 |
| Price-to-Sales (TTM) | 150.46 |
| EV/Revenue | 134.23 |
| EV/EBITDA | 86.48 |
| Quarterly Earnings Growth (YoY) | 0.00% |
| Quarterly Revenue Growth (YoY) | -100.00% |
| Shares Outstanding | $160.29M |
| Float | $155.53M |
| % Insiders | 4.59% |
| % Institutions | 100.04% |
Volatility is currently expanding
Denali Therapeutics gains 7.8% as Avlayah sales surge nearly fivefold, reimbursement coverage expands and multiple pipeline catalysts approach.
Denali Therapeutics Inc. (DNLI) Q3 2026 Earnings Call Transcript
AVLAYAH® (tividenofusp alfa-eknm) net product revenue accelerated to $17.8 million in its second full commercial quarter Continued growth expectations drive Q4 2026 net product revenue guidance of $30.0 million to $32.0 million AVLAYAH recognized as the “Best Biotechnology Product” of 2026 by The Galien Foundation Zafinofusp alfa advancing as Denali's second potential product, with BLA submission on track for 2027 seeking accelerated approval for Sanfilippo syndrome type A (MPS IIIA) Five TransportVehicle™ (TV) programs expected to generate data in 2027: zafinofusp alfa (ETV:SGSH), DNL593 (PTV:PGRN), DNL628 (OTV:MAPT), DNL921 (ATV:Abeta) and DNL952 (ETV:GAA) Q3 2026 net income of $70.1 million included a one-time $194.0 million net gain on the sale of a Priority Review Voucher, bringing cash, cash equivalents and marketable securities to $1.0 billion Conference call and webcast today at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif.
SOUTH SAN FRANCISCO, Calif., Oct. 30, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that AVLAYAH® (tividenofusp alfa-eknm) has been recognized as the “Best Biotechnology Product” of 2026 by The Galien Foundation. AVLAYAH is the first biologic approved by the U.S. Food and Drug Administration (FDA) that is specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. AVLAYAH is an enzyme replacement therapy that received FDA accelerated approval in March 2026 for the treatment of neurologic manifestations of a rare neurodegenerative disease called Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory study.
SOUTH SAN FRANCISCO, Calif., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that it will report financial results and business highlights for the third quarter ended September 30, 2026, on Tuesday, November 3, 2026.
Denali Therapeutics Inc. (DNLI) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript
Denali's Avlayah launch drives strong uptake and a 33.1% three-month stock gain, but regulatory and pipeline risks remain.
AVLAYAH's approval has helped validate Denali Therapeutics' TransportVehicle platform. They're now moving into their commercial stage as a business. Early payer coverage and Q3 guidance support a credible launch ramp. However, AVLAYAH's US label limits its near-term potential. Zafinofusp alfa and four TV-enabled 2027 readouts provide meaningful pipeline upside beyond AVLAYAH.
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.
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