Biotech · Public company · South San Francisco, CA, US
Denali Therapeutics Inc.
Ticker DNLI · SEC CIK 0001714899
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Clinical trials207 recruiting or active
Pipeline programs13From trials and the company's site
Disclosed deals0None found yet
Cash runwayNot availableNo recent cash burn filed
Pipeline13
- idursulfasePhase 3 · Mucopolysaccharidosis IIClinicalTrials.gov · fetched Nov 12, 2026
- tividenofusp alfaPhase 3 · Mucopolysaccharidosis IIClinicalTrials.gov · fetched Nov 12, 2026
- BIIB122 225 mgPhase 2 · Parkinson DiseaseClinicalTrials.gov · fetched Nov 12, 2026
- DNL126Phase 2 · Mucopolysaccharidosis Type IIIAClinicalTrials.gov · fetched Nov 12, 2026
- DNL593Phase 2 · Frontotemporal DementiaClinicalTrials.gov · fetched Nov 12, 2026
- Prophylactic immunomodulatory therapyPhase 2 · Mucopolysaccharidosis Type IIIAClinicalTrials.gov · fetched Nov 12, 2026
- [14C]-DNL343Phase 1 · Healthy VolunteersClinicalTrials.gov · fetched Nov 12, 2026
- DNL201Phase 1 · Healthy VolunteersClinicalTrials.gov · fetched Nov 12, 2026
- DNL201Phase 1 · Parkinson DiseaseClinicalTrials.gov · fetched Nov 12, 2026
- DNL343Phase 1 · Amyotrophic Lateral SclerosisClinicalTrials.gov · fetched Nov 12, 2026
- DNL747Phase 1 · Alzheimer DiseaseClinicalTrials.gov · fetched Nov 12, 2026
- DNL952Phase 1 · Late-onset Pompe DiseaseClinicalTrials.gov · fetched Nov 12, 2026
- No InterventionMucopolysaccharidosis IIClinicalTrials.gov · fetched Nov 12, 2026
Clinical trials20
- A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe DiseasePHASE1 · RECRUITING · started May 12, 2026ClinicalTrials.gov NCT07354724 · fetched Nov 12, 2026
- Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)PHASE2 · ACTIVE_NOT_RECRUITING · started Oct 24, 2024ClinicalTrials.gov NCT06602193 · fetched Nov 12, 2026
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male ParticipantsPHASE1 · COMPLETED · started Mar 1, 2024ClinicalTrials.gov NCT06281158 · fetched Nov 12, 2026
- Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)PHASE1_PHASE2 · RECRUITING · started Dec 7, 2023ClinicalTrials.gov NCT06181136 · fetched Nov 12, 2026
- An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007PHASE2_PHASE3 · ENROLLING_BY_INVITATION · started Sep 20, 2023ClinicalTrials.gov NCT06075537 · fetched Nov 12, 2026
- HEALEY ALS Platform Trial - Regimen G DNL343PHASE2_PHASE3 · COMPLETED · started May 24, 2023ClinicalTrials.gov NCT05842941 · fetched Nov 12, 2026
- A Natural History Study of Biomarkers and Clinical Outcomes in Mucopolysaccharidosis Type IIIA (MPS IIIA; Sanfilippo Syndrome)COMPLETED · started Sep 27, 2022ClinicalTrials.gov NCT05523206 · fetched Nov 12, 2026
- A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating ScalePHASE3 · TERMINATED · started Aug 26, 2022ClinicalTrials.gov NCT05418673 · fetched Nov 12, 2026
- A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)PHASE2_PHASE3 · ACTIVE_NOT_RECRUITING · started Jul 21, 2022ClinicalTrials.gov NCT05371613 · fetched Nov 12, 2026
- A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80PHASE2 · COMPLETED · started Apr 19, 2022ClinicalTrials.gov NCT05348785 · fetched Nov 12, 2026
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)PHASE1_PHASE2 · ACTIVE_NOT_RECRUITING · started Feb 1, 2022ClinicalTrials.gov NCT05262023 · fetched Nov 12, 2026
- A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male SubjectsPHASE1 · COMPLETED · started Aug 27, 2021ClinicalTrials.gov NCT05119790 · fetched Nov 12, 2026
- A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral SclerosisPHASE1 · COMPLETED · started Aug 11, 2021ClinicalTrials.gov NCT05006352 · fetched Nov 12, 2026
- A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy SubjectsPHASE1 · COMPLETED · started Jul 28, 2021ClinicalTrials.gov NCT05005338 · fetched Nov 12, 2026
- A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter SyndromePHASE1_PHASE2 · ACTIVE_NOT_RECRUITING · started Jul 16, 2020ClinicalTrials.gov NCT04251026 · fetched Nov 12, 2026
- A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter SyndromeCOMPLETED · started Oct 23, 2019ClinicalTrials.gov NCT04007536 · fetched Nov 12, 2026
- Study to Evaluate DNL747 in Subjects With Alzheimer's DiseasePHASE1 · COMPLETED · started Feb 13, 2019ClinicalTrials.gov NCT03757325 · fetched Nov 12, 2026
- Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral SclerosisPHASE1 · TERMINATED · started Dec 14, 2018ClinicalTrials.gov NCT03757351 · fetched Nov 12, 2026
- Study to Evaluate DNL201 in Subjects With Parkinson's DiseasePHASE1 · COMPLETED · started Dec 4, 2018ClinicalTrials.gov NCT03710707 · fetched Nov 12, 2026
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy VolunteersPHASE1 · COMPLETED · started Jun 1, 2017ClinicalTrials.gov NCT04551534 · fetched Nov 12, 2026
SEC filings12
- 10-Q · 10-QSEC EDGAR · filed Nov 3, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed Nov 3, 2026 · fetched Nov 12, 2026
- 10-Q · 10-QSEC EDGAR · filed Aug 6, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed Aug 6, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed Jul 28, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed Jun 18, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed Jun 4, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed May 22, 2026 · fetched Nov 12, 2026
- 10-Q · 10-QSEC EDGAR · filed May 7, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed May 7, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed Apr 3, 2026 · fetched Nov 12, 2026
- 8-K · 8-KSEC EDGAR · filed Mar 31, 2026 · fetched Nov 12, 2026