DNLI (Denali Therapeutics Inc.) stock: $19.72, $3.15B market cap, $710.5M cash, $2.44B EV, $4.23B fully diluted market cap. Next expected readout: Dec-26. Lead program: tividenofusp alfa (Mucopolysaccharidosis II), Phase 3. Data from Fully Diluted's biotech stocks database.
Pipeline assets
AVLAYAH
Approved · Active Modality: enzyme replacement therapy (ETV-enabled, BBB-crossing biologic)
Aliases tividenofusp alfa, ETV:IDS, DNL310
Target IDS (iduronate 2-sulfatase)
Partnerships Company retains worldwide rights; Royalty Pharma synthetic royalty (9.25% of worldwide net sales, $200M received on approval plus $75M on EMA approval by December 31, 2029); Genentech license; F-star milestone ($36M due on FDA approval, $24M EU milestone pending)
Indications- Hunter syndrome (MPS II) neurologic manifestations (Approved)
Status note FDA accelerated approval March 24, 2026 for presymptomatic or symptomatic pediatric patients at least 5 kg; commercial distribution began April 2026. Continued approval contingent on confirmatory evidence from ongoing global Phase 2/3 COMPASS trial. Rare Pediatric Disease PRV sold for $195M (closed July 2026).
Zafinofusp alfa
Phase 2 · Active Modality: enzyme replacement therapy (ETV-enabled biologic)
Aliases DNL126, ETV:SGSH
Target SGSH (N-sulfoglucosamine sulfohydrolase)
Partnerships Company retains rights; START program selection (June 2024)
Indications- Sanfilippo syndrome type A (MPS IIIA) (Phase 2)
Status note Open-label Phase 1/2 study enrollment completed September 2025.
DNL593
Phase 2 · Active Modality: biologic (protein transport vehicle)
Aliases PTV:PGRN, TAK-594
Target PGRN (progranulin)
Partnerships Takeda collaboration terminated April 2026 (effective June 2026); all rights reverted to Company. Termination driven by strategic considerations, not efficacy or safety data
Indications- Frontotemporal dementia-granulin (FTD-GRN) (Phase 2)
Status note Company continues to conduct the Phase 1/2 study of DNL593 for FTD-GRN following Takeda termination.
DNL628
Phase 1 · Active Modality: oligonucleotide
Aliases OTV:MAPT
Target MAPT (tau)
Partnerships not disclosed
Indications- Alzheimer's disease (Phase 1)
Status note Phase 1b CTA approved January 2026; first patient dosed March 2026.
DNL952
Phase 1 · Active Modality: enzyme replacement therapy (ETV-enabled biologic)
Aliases ETV:GAA
Target GAA
Partnerships not disclosed
Status note FDA lifted IND clinical hold January 2026; Phase 1 study enrolling.
DNL921
Phase 1 · Active Modality: antibody (ATV-enabled)
Aliases ATV:Abeta
Target amyloid beta
Partnerships Biogen ROFN and Option Agreement includes option/right of first negotiation to ATV amyloid beta program
Indications- Alzheimer's disease (Phase 1)
Status note CTA submitted first half 2026 to initiate Phase 1/1b study in healthy volunteers and Alzheimer's participants; study underway.
DNL151
Phase 2 · Active Modality: small molecule (oral)
Target LRRK2
Partnerships Biogen: LRRK2 co-development/co-commercialization license (October 2020); R&D funding collaboration with unrelated third party (up to $75M) for BEACON study
Indications- Parkinson's disease (LRRK2 pathogenic variant carriers) (Phase 2)
- Parkinson's disease (idiopathic) (Phase 2)
Status note Development in idiopathic Parkinson's discontinued (May 2026). Company continues Phase 2a BEACON study in LRRK2 variant carriers independently.
Per-asset detail extracted from the 10-Q filed 2026-08-06. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.