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Denali Therapeutics (DNLI) investor relations material
Denali Therapeutics Baird Global Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Company overview and technology platform
Focused on crossing the blood-brain barrier and treating neurodegeneration using transport vehicle (TV) technology, which enables delivery of enzymes, oligonucleotides, and antibodies to the brain and other tissues.
TV technology is modular, using Fc-engineered antibodies to bind transferrin receptor, allowing broad application across multiple diseases.
Lead program in Hunter syndrome has achieved both brain delivery and biomarker evidence of halted neurodegeneration.
BLA filed for lead asset in Hunter syndrome, with active FDA engagement and additional programs advancing in Alzheimer's and other indications.
Clinical progress and data highlights
In Hunter syndrome, TV platform normalized heparan sulfate in CSF and urine, corrected lysosomal biomarkers, and improved cognition, behavior, and hearing.
Robust reductions in biomarkers observed even in patients previously treated with gene therapy, demonstrating whole-body and brain efficacy.
Majority of patients switched from standard of care to TV for better outcomes; over 90% reduction in CSF biomarkers achieved.
Sanfilippo syndrome program (DNL126) shows similar biomarker normalization, with rapid disease progression and no current standard of care.
Regulatory and commercial strategy
Lead asset under FDA priority review for accelerated approval, with a PDUFA date in January 2026.
Commercial strategy targets centers of excellence and emphasizes patient services and support for switching from standard of care.
Strong overlap in clinical and commercial teams for Hunter and Sanfilippo programs, leveraging established relationships with centers and FDA reviewers.
Engaged FDA review teams, rapid BLA submission process, and alignment with recent rare disease regulatory guidance.
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