Denali Therapeutics Inc
denalitherapeutics.comWhat Do They Do?
Develops biotherapeutic medicines for people with serious diseases, including neurodegenerative diseases and lysosomal storage disorders.
10-K for FY2025, filed Feb 26, 2026Our purpose is to bring the power of biotherapeutics to the whole body, including the brain, by discovering, developing, and delivering…View ↗
We are building a broad portfolio of therapeutic candidates by investing in our TV franchises, i.e., Enzyme TV ("ETV"), Oligonucleotide TV…View ↗
We invented, developed, and continue to optimize a proprietary technology, called the TransportVehicleTM ("TV"), to deliver our large…View ↗
Who Are Their Customers?
Denali works with biopharmaceutical companies through collaborations to develop and commercialize medicines; it plans to sell approved medicines itself in key markets and may use partners or distributors to reach patients elsewhere.
10-K for FY2025, filed Feb 26, 2026We have established commercial readiness for tividenofusp alfa including continued dialogue with advocacy groups, prescribers and payers…View ↗
Our therapeutic portfolio also includes BIIB122/DNL151 (LRRK2 inhibitor) for Parkinson's disease, a small molecule drug candidate that does…View ↗
Collaborations and partnering are central components of our strategy to build, develop, and commercialize our portfolio of product…View ↗
How Are They Changing?
- Net income
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Sources
10-Q for Q2 FY2026, filed Aug 6, 2026
−$127.6MView ↗
- ▲ +3% (Loss)
- vs −$124.1M in Q2 FY2025
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Aug 6, 2026
Denali projects third-quarter AVLAYAH revenue of $10.0 million to $12.0 million
Sources
8-K, filed Aug 6, 2026
In its first full quarter of commercial availability, AVLAYAH generated $3.6 million in net product revenue. Projected third-quarter 2026…View ↗
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Apr 3, 2026
Takeda ends the DNL593 collaboration, returning program rights to Denali
Denali said it plans to continue DNL593's clinical development independently.
Sources
8-K, filed Apr 3, 2026
On April 3, 2026, Denali Therapeutics Inc. (“Denali”) received written notice from Takeda Pharmaceutical Company Limited (“Takeda”) of its…View ↗
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Mar 25, 2026
FDA approves AVLAYAH for neurologic manifestations of Hunter syndrome
Approval is accelerated and applies to specified pediatric patients.
Sources
8-K, filed Mar 25, 2026
On March 25, 2026, Denali Therapeutics Inc., a Delaware corporation (the “Company”), issued a press release announcing that the U.S. Food…View ↗
Preparing for commercial sales
The older report described plans to build commercial infrastructure and serve patients directly in key markets. The latest report describes commercial readiness for its lead Hunter syndrome therapy and a team intended to support launches.
10-K for FY2022, filed Feb 27, 2023 10-K for FY2025, filed Feb 26, 2026Our target indications include diseases with large patient populations, such as Alzheimer’s disease and Parkinson’s disease, as well as…View ↗
We have established commercial readiness for tividenofusp alfa including continued dialogue with advocacy groups, prescribers and payers…View ↗
Broader delivery beyond the brain
The older report described the Transport Vehicle as delivering large-molecule medicines to the brain. The latest report describes delivery throughout the body, including muscle and other tissues.
10-K for FY2022, filed Feb 27, 2023 10-K for FY2025, filed Feb 26, 2026We invented, developed, and continue to optimize a proprietary technology, called the Transport Vehicle, to deliver our large molecule…View ↗
We invented, developed, and continue to optimize a proprietary technology, called the TransportVehicleTM ("TV"), to deliver our large…View ↗
Who Do They Compete With?
Competes with Biogen, Eisai, Eli Lilly, Arrowhead, Roche, AbbVie, Bristol Myers Squibb, Prothena, Regeneron, Alnylam, BioArctic, AstraZeneca, Ionis, GSK, Passage Bio, AviadoBio, Vesperbio, Arkuda Therapeutics, JCR Pharmaceuticals, and RegenxBio
10-K for FY2025, filed Feb 26, 2026Alzheimer’s Disease: Treatments currently approved in some geographies for Alzheimer’s Disease include the amyloid beta-directed antibody…View ↗
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