Headquartered in South San Francisco, CA Fiscal year ends December NASDAQ: DNLI denalitherapeutics.com
Denali Therapeutics is a commercial-stage biotechnology company developing biotherapeutics that cross the blood-brain barrier (BBB) using its proprietary TransportVehicle (TV) platform.
**Platform.** The platform uses engineered Fc domains that bind natural transport receptors at the BBB, such as the transferrin receptor and CD98 heavy chain. This lets antibodies, enzymes, proteins and oligonucleotides be delivered systemically throughout the body, including the brain. Platform variants include:
- Enzyme (ETV)
- Protein (PTV)
- Antibody (ATV)
- Oligonucleotide (OTV)
**Commercial product.** Denali's first commercial product is AVLAYAH (tividenofusp alfa-eknm). It is an ETV-enabled enzyme replacement therapy that received FDA accelerated approval in March 2026 for the neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients. It is currently sold in the United States, and the confirmatory Phase 2/3 COMPASS study is intended to support adult label expansion and global submissions.
**Clinical pipeline.**
- Zafinofusp alfa (DNL126) for Sanfilippo syndrome type A, with a BLA planned for 2027.
- DNL593 for FTD-GRN.
- DNL952 for Pompe disease.
- DNL628 (tau-targeting ASO) and DNL921 (amyloid antibody) for Alzheimer's disease.
- DNL151, a LRRK2 inhibitor, for Parkinson's disease.
**IND-enabling programs.** DNL111 (Parkinson's/Gaucher), DNL622 (MPS I) and DNL422 (Parkinson's).
The company targets neurodegenerative diseases, lysosomal storage disorders and other serious diseases. Updated
The swing to positive EPS came from a one-time $194 million gain on a Priority Review Voucher sale, with an operating loss of $126.8 million. On the Hunter syndrome launch, revenue missed expectations, but management guided fourth-quarter AVLAYAH sales to $30 million to $32 million as payer coverage widened past 70% of US commercial lives.
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Denali Therapeutics is a commercial-stage biotechnology company developing biotherapeutics that cross the blood-brain barrier (BBB) using its proprietary TransportVehicle (TV) platform. **Platform.** The platform uses engineered Fc domains that bind natural transport receptors at the BBB, such as the transferrin…
The Wall Street consensus 12-month price target for DNLI is $36.19.
