Company profile

Denali Therapeutics Inc.

Pipeline11 assets

tividenofusp alfa-eknmDNL310; ETV:IDS / AVLAYAH / IDS enzyme replacement; TfR TransportVehicle-enabled delivery / Enzyme TransportVehicle biologic / Lysosomal storage disorders
Hunter syndrome (MPS II)Approved; Phase 2/3 confirmatory study ongoingU.S. accelerated approval; global Phase 2/3 COMPASS ongoingUSGlobal
DNL126ETV:SGSH / SGSH enzyme replacement / Enzyme TransportVehicle biologic / Lysosomal storage disorders
Sanfilippo syndrome Type A (MPS IIIA)Phase 1/2; Phase 3 plannedOngoing Phase 1/2; global Phase 3 confirmatory study plannedGlobal
DNL593TAK-594/DNL593; PTV:PGRN / Progranulin replacement / Protein TransportVehicle biologic / Neurodegenerative disease
GRN-related frontotemporal dementia (FTD-GRN)Phase 1/2Ongoing; Denali received notice that Takeda will terminate collaboration, with Denali planning to continue developmentGlobal
DNL628OTV:MAPT / MAPT / tau / Oligonucleotide TransportVehicle therapeutic / Neurodegenerative disease
Alzheimer's diseasePhase 1bCTA approved; study start-up underway
DNL952ETV:GAA / GAA enzyme replacement / Enzyme TransportVehicle biologic / Lysosomal storage disorders
Pompe diseasePhase 1IND clinical hold lifted; proceeding to Phase 1US
BIIB122/DNL151DNL151; BIIB122 / LRRK2 / Small molecule inhibitor / Neurodegenerative disease
Parkinson's diseasePhase 2bLUMA enrollment completed; readout expected 2026GlobalLRRK2-associated Parkinson's diseasePhase 2aBEACON ongoing
eclitasertibSAR443122/DNL758 / RIPK1 / Small molecule inhibitor / Inflammatory disease
Ulcerative colitisPhase 2Developed by Sanofi; Phase 2 results expected in 1H 2026
DNL921ATV:Abeta / Amyloid beta / Antibody TransportVehicle therapeutic / Neurodegenerative disease
Alzheimer's diseaseIND-enablingPhase 1/1b initiation planned
DNL111ETV:GCase / GCase / Enzyme TransportVehicle biologic / Neurodegenerative disease; lysosomal storage disorders
Parkinson's diseaseIND-enablingIND-enablingGaucher diseaseIND-enablingIND-enabling
DNL622ETV:IDUA / IDUA enzyme replacement / Enzyme TransportVehicle biologic / Lysosomal storage disorders
MPS IIND-enablingIND-enabling
DNL422OTV:SNCA / SNCA / alpha-synuclein / Oligonucleotide TransportVehicle therapeutic / Neurodegenerative disease
Parkinson's diseaseIND-enablingIND-enabling

Latest news8 items

Aug 6, 2026

Denali Therapeutics Reports Second Quarter 2026 Financial Results and Business Highlights

Strong first full quarter of AVLAYAH™ (tividenofusp alfa-eknm) launch generated $3.6 million in net product revenue Advanced TransportVehicle™ portfolio with two Alzheimer’s disease programs now in clinical development $195 million in gross proceeds received in July 2026 from sale of a Priority

Enrollment • Phase 1/2

Jul 27, 2026

Denali Therapeutics to Report Second Quarter 2026 Financial Results and Business Highlights on August 6, 2026

SOUTH SAN FRANCISCO, Calif., July 27, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that it will report financial results and business highlights for the second quarter ended June 30, 2026, on Thursday, August 6, 2026.

Jul 9, 2026

Denali Therapeutics to Give Opening Plenary Address at Alzheimer’s Association International Conference (AAIC) 2026 and Highlight Breakthroughs in Delivering Biologic Therapies Across Blood-Brain Barrier

Denali co-founder and CEO Ryan Watts, Ph.D., to deliver opening plenary address at 2026 AAIC in London on July 12, 2026 Presentation will highlight recent scientific advances and future opportunities to accelerate discovery and development of medicines for neurodegenerative diseases Denali is

Jun 18, 2026

Denali Therapeutics Enters Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $195 Million

Proceeds from transaction to support advancement of Denali’s broad TransportVehicle™-enabled clinical portfolio for lysosomal storage disorders and neurodegenerative diseases Denali was awarded Priority Review Voucher following FDA approval of AVLAYAH™, the first FDA-approved biologic specifically

May 21, 2026

Biogen and Denali Therapeutics Provide Update on Phase 2b LUMA Study of BIIB122 (DNL151) in Early-Stage Parkinson’s Disease

The Phase 2b LUMA study of BIIB122 in early-stage Parkinson’s disease did not meet its primary or secondary endpoints Based on data from the Phase 2b LUMA study, Biogen and Denali will discontinue development of BIIB122 in idiopathic Parkinson’s disease Denali continues to independently conduct

Trial Results • Phase 2Results event Thu, May 21, 2026

May 7, 2026

Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights

FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting

Trial Start • Phase 1

Apr 3, 2026

Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)

Denali plans to continue clinical development of DNL593, which is designed to deliver progranulin to the brain using TransportVehicle™ technology Results from ongoing Phase 1/2 study in patients with FTD-GRN expected by the end of 2026 SOUTH SAN FRANCISCO, Calif., April 03, 2026 (GLOBE NEWSWIRE) --

Mar 25, 2026

Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)

First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage disease First FDA-approved medicine in emerging new class of biotherapeutics that leverage transferrin receptor to cross blood-brain barrier Denali’s first medicine enabled by its