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Denali Therapeutics (DNLI) investor relations material
Denali Therapeutics Stifel 2025 Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Stifel 2025 Healthcare Conference summary12 Nov, 2025
Strategic vision and technology
Focused on crossing the blood-brain barrier and defeating neurodegeneration using transport vehicle technology, leveraging transferrin receptor for CNS delivery.
Pipeline progress includes late-stage and new clinical programs, with regulatory filings for multiple modalities.
Three main franchises: enzyme transport vehicle (ETV), oligonucleotide, and protein replacement therapies.
ETV franchise includes programs for Hunter syndrome (BLA under review), Sanfilippo (accelerated approval planned), Pompe (entering trials), and FTD granulin.
First oligonucleotide program targeting MAPT (tau) has entered the clinic, with an amyloid beta program close to filing.
Regulatory and clinical updates
Hunter syndrome BLA review delayed by FDA due to a clerical error, shifting PDUFA date to April 5, but engagement remains positive and collaborative.
Launch preparations underway with a small, ready field team for Hunter and Sanfilippo, with plans to expand for Pompe.
Market access strategy divides global opportunity into thirds: US, ex-US accessible with accelerated approval, and Europe requiring additional clinical endpoints.
Sanfilippo program completed Phase 1/2 enrollment (20 patients), with data expected 49 weeks post-September and BLA filing preparation underway.
Sanfilippo manufacturing is in-house, marking a shift from previous reliance on external partners.
Clinical data and trial design
Robust biomarker effects observed in Sanfilippo and Hunter programs, with neurocognitive, behavioral, and hearing data maturing.
Hunter confirmatory trial uses active comparator and co-primary endpoints of CSF heparan sulfate and Vineland behavioral scale; enrollment to complete by year-end, with trial completion expected in 2027.
Sanfilippo trial likely to use natural history as comparator due to lack of standard of care, with similar endpoints as Hunter.
Pompe program addresses unmet needs in both neuro and muscle domains, with further strategy details to be shared at Analyst Day.
DNL310 PDUFA delay: Is early approval possible?
Oligo TV: How does CNS distribution compare?
TV-Abeta: How does it shift ARIA safety profile?
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Next Denali Therapeutics earnings date
Jefferies London Healthcare Conference 202518 Nov, 2025
Next Denali Therapeutics earnings date
Jefferies London Healthcare Conference 202518 Nov, 2025
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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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