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Denali Therapeutics (DNLI) investor relations material
Denali Therapeutics Investor Day 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Investor Day 2025 summary4 Dec, 2025
Strategic vision and platform innovation
Expanding focus from neurodegeneration to whole-body biotherapeutics, leveraging the TransportVehicle (TV/Tivi) platform for delivery to brain, muscle, and other hard-to-reach tissues.
TV platform includes Enzyme TV (ETV), Antibody TV (ATV), and Oligonucleotide TV (OTV), enabling broad therapeutic applications in neurodegenerative and lysosomal storage disorders.
D3 strategy centers on Discover, Develop, and Deliver, aiming for blockbuster potential across ETV, ATV, and OTV franchises.
The platform is modular, engineered for optimal brain uptake, safety, and manufacturability, with over 11,000 doses administered and more than 350 patents/applications.
TV is the most clinically validated BBB technology, with demonstrated ability to correct neurodegeneration and broad clinical experience.
Pipeline, clinical progress, and near-term launches
Two near-term launches: tividenofusp alfa (Tivi/DNL310) for MPS II in 2026 and DNL126 for MPS IIIA in 2027, establishing the ETV franchise.
Tividenofusp alfa has shown normalization of key biomarkers and clinical improvements in MPS II, with a BLA filed for accelerated approval and a PDUFA date of April 5, 2026.
DNL126 achieved biomarker proof-of-concept in MPS IIIA, with Phase 1/2 enrollment completed and Phase 3 protocol in development; BLA submission expected in 2027.
Deep pipeline includes programs for Alzheimer's, Parkinson's, Pompe, Gaucher, and FTD-GRN, with several IND-enabling and clinical-stage assets.
Manufacturing facility in Salt Lake City enables rapid, flexible, and cost-effective production, supporting both clinical and commercial supply.
Commercial strategy and market opportunity
ETV franchise targets lysosomal storage disorders with a combined market opportunity exceeding $1B for the first two launches and $5B+ total.
Commercial launch plans include high-touch engagement, seamless access, and established relationships with all major MPS II treatment centers.
Pricing strategy aims for a premium to standard of care, reflecting clinical and societal value while ensuring broad access and affordability.
Commercial model designed for scalability and repeatability, leveraging synergies between products and customer base.
Royalty Pharma partnership provides $275M in funding, supporting launch and portfolio execution, with royalties capped at 2.5x/3x sales.
Detail DNL310/DNL126 market growth drivers
Explain TV platform's safety differentiation
Quantify DNL126's development cost efficiency
Tivi: Payer mix impact on early adoption?
TV platform's key differentiation vs. competitors?
What drives DNL126's faster, cheaper development?
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Next Denali Therapeutics earnings date
Q4 202527 Feb, 2026
Next Denali Therapeutics earnings date
Q4 202527 Feb, 2026
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Frequently asked questions
Denali Therapeutics Inc is a biotechnology company focused on developing therapies for neurodegenerative diseases. The company researches and creates treatments targeting conditions such as Alzheimer's disease, Parkinson’s disease, and other disorders affecting the central nervous system. Denali Therapeutics operates within the healthcare and biotechnology sectors. The company is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.
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