| Symbol | DNLI |
|---|---|
| Name | DENALI THERAPEUTICS INC. |
| Sector | HEALTH CARE |
| Region | North America |
| Industry | Biotechnology: Biological Products (No Diagnostic Substances) |
| Address | 161 OYSTER POINT BOULEVARD, SOUTH SAN FRANCISCO, California, 94080, United States |
| Telephone | +1 650 866-8548 |
| Fax | — |
| — | |
| Website | https://www.denalitherapeutics.com |
| Incorporation | UNDEFINED |
| Incorporated On | — |
| Employees | — |
| Fiscal Year | — |
| Public Since | — |
| Exchanges | NASDAQ |
| Auditor | — |
| Audit Status | NOT PROVIDED |
| Reporting Status | — |
| CIK | 0001714899 |
| Description | Denali Therapeutics Inc is a biotechnology company that is engaged in developing and discovering therapeutics to defeat neurodegeneration disease. The companys development programs include the LRRK2 Inhibitor Program, which develops brain penetrant small molecule LRRK2 inhibitor product candidates for Parkinsons disease. Its key products include DNL201, DNL151, DNL747, ATV (Antibody Transport Vehicle), ETV (Enzyme Transport Vehicle), and others. Additional info from NASDAQ: |
(10% Negative) DENALI THERAPEUTICS INC. (DNLI) Reports Q2 2026 Financial Results
Read moreDenali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights
Read moreNew Form 3/A - Denali Therapeutics Inc. <b>Filed:</b> 2026-04-21 <b>AccNo:</b> 0002124755-26-000002 <b>Size:</b> 4 KB
Read moreNew Form DEFA14A - Denali Therapeutics Inc. <b>Filed:</b> 2026-04-21 <b>AccNo:</b> 0001714899-26-000056 <b>Size:</b> 1 MB
Read moreNew Form 3 - Denali Therapeutics Inc. <b>Filed:</b> 2026-04-20 <b>AccNo:</b> 0001714899-26-000049 <b>Size:</b> 237 KB
Read moreDenali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)
Read more(99% Neutral) DENALI THERAPEUTICS INC. (DNLI) Announces Business Combination
Read moreNew Form SCHEDULE 13G/A - Denali Therapeutics Inc. <b>Filed:</b> 2026-03-26 <b>AccNo:</b> 0000102909-26-001186 <b>Size:</b> 7 KB
Read more(10% Negative) DENALI THERAPEUTICS INC. (DNLI) Announces Delay in approval Trials for AVLAYAH™ (tividenofusp alfa-eknm) Due to Pandemic-Related Challenges, Patient Enrollment Issues, Regulatory Process, Safety Review, Efficacy Assessment
Read moreDenali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
Read more| Trial ID | Title | Phase | Indication | Status | Start Date | Completion Date | Source |
|---|---|---|---|---|---|---|---|
| NCT07354724 | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL95… | Phase1 | Late-onset Pompe Disease | Not_Yet_Recruiting | 2026-03-01 | 2028-08-01 | ClinicalTrials.gov |
| NCT07328451 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodyn… | Phase1 | Alzheimer Disease, Early Onset | Recruiting | 2026-01-30 | 2027-02-01 | ClinicalTrials.gov |
| NCT06602193 | Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associ… | Phase2 | Parkinson Disease | Recruiting | 2024-10-24 | 2028-02-28 | ClinicalTrials.gov |
| NCT06281158 | A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14… | Phase1 | Healthy Volunteers | Completed | 2024-03-01 | 2024-04-30 | ClinicalTrials.gov |
| NCT06181136 | Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA … | Phase1 | Mucopolysaccharidosis Type IIIA | Active_Not_Recruiting | 2023-12-07 | 2028-08-01 | ClinicalTrials.gov |
| NCT06075537 | An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tivid… | Phase2 | Mucopolysaccharidosis II | Enrolling_By_Invitation | 2023-09-20 | 2027-06-01 | ClinicalTrials.gov |
| NCT05842941 | HEALEY ALS Platform Trial - Regimen G DNL343 | Phase2 | Amyotrophic Lateral Sclerosis | Completed | 2023-05-24 | 2024-10-29 | ClinicalTrials.gov |
| NCT05523206 | A Natural History Study of Biomarkers and Clinical Outcomes in Mucopolysacchari… | — | Mucopolysaccharidosis III-A | Completed | 2022-09-27 | 2025-01-28 | ClinicalTrials.gov |
| NCT05418673 | A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-S… | Phase3 | Parkinson Disease | Terminated | 2022-08-26 | 2023-07-27 | ClinicalTrials.gov |
| NCT05371613 | A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs I… | Phase2 | Mucopolysaccharidosis II | Recruiting | 2022-07-21 | 2027-12-01 | ClinicalTrials.gov |
| NCT05450549 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodyn… | Phase1 | Healthy Participant | Completed | 2022-07-14 | 2023-06-08 | ClinicalTrials.gov |
| NCT05348785 | A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow … | Phase2 | Parkinson Disease | Active_Not_Recruiting | 2022-04-19 | 2026-03-09 | ClinicalTrials.gov |
| NCT05262023 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodyn… | Phase1 | Frontotemporal Dementia | Active_Not_Recruiting | 2022-02-01 | 2028-11-01 | ClinicalTrials.gov |
| NCT05119790 | A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite I… | Phase1 | Healthy Volunteers | Completed | 2021-08-27 | 2021-11-05 | ClinicalTrials.gov |
| NCT05006352 | A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL3… | Phase1 | Amyotrophic Lateral Sclerosis | Completed | 2021-08-11 | 2024-06-05 | ClinicalTrials.gov |
| NCT05005338 | A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy … | Phase1 | Healthy Volunteers | Completed | 2021-07-28 | 2021-09-23 | ClinicalTrials.gov |
| NCT04581772 | A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunte… | Phase1 | Healthy Volunteers | Completed | 2020-12-23 | 2021-06-04 | ClinicalTrials.gov |
| NCT04251026 | A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syn… | Phase1 | Mucopolysaccharidosis II | Active_Not_Recruiting | 2020-07-16 | 2031-02-01 | ClinicalTrials.gov |
| NCT04268784 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodyn… | Phase1 | Healthy Volunteers | Completed | 2020-02-20 | 2021-08-03 | ClinicalTrials.gov |
| NCT04007536 | A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in H… | — | Mucopolysaccharidosis II | Completed | 2019-10-23 | 2024-03-01 | ClinicalTrials.gov |
| NCT03757325 | Study to Evaluate DNL747 in Subjects With Alzheimer's Disease | Phase1 | Alzheimer Disease | Completed | 2019-02-13 | 2019-12-05 | ClinicalTrials.gov |
| NCT03710707 | Study to Evaluate DNL201 in Subjects With Parkinson's Disease | Phase1 | Parkinson Disease | Completed | 2018-12-04 | 2019-12-06 | ClinicalTrials.gov |
| NCT04557800 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodyn… | Phase1 | Healthy Volunteers | Completed | 2017-11-16 | 2021-02-19 | ClinicalTrials.gov |
| NCT04551534 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodyn… | Phase1 | Healthy Volunteers | Completed | 2017-06-01 | 2018-08-08 | ClinicalTrials.gov |
| Product Name | Type | Development Stage | Therapeutic Area | Study Status | Trial ID |
|---|---|---|---|---|---|
| Placebo | Other | Phase PHASE1 | Parkinson Disease | COMPLETED | NCT03710707 |
| DNL201 | Other | Phase PHASE1 | Parkinson Disease | COMPLETED | NCT03710707 |
| Placebo | Other | Phase PHASE1 | Alzheimer Disease | COMPLETED | NCT03757325 |
| DNL747 | Other | Phase PHASE1 | Alzheimer Disease | COMPLETED | NCT03757325 |
| Placebo | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04551534 |
| DNL201 | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04551534 |
| Placebo | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04581772 |
| DNL343 | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04581772 |
| [14C] BIIB122 ([14C] DNL151) | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT05005338 |
| BIIB122 (DNL151) | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT05005338 |
| [14C] BIIB122 ([14C] DNL151) | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT05119790 |
| Placebo | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04268784 |
| DNL343 | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04268784 |
| Placebo | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04557800 |
| DNL151 | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04557800 |
| Placebo | Other | Phase PHASE1 | Healthy Participant | COMPLETED | NCT05450549 |
| DNL919 | Other | Phase PHASE1 | Healthy Participant | COMPLETED | NCT05450549 |
| No Intervention | Other | Preclinical | Mucopolysaccharidosis II | COMPLETED | NCT04007536 |
| [14C]-DNL343 | Other | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT06281158 |
| BIIB122-Matching Placebo | Other | Phase PHASE3 | Parkinson Disease | TERMINATED | NCT05418673 |
| BIIB122 | Other | Phase PHASE3 | Parkinson Disease | TERMINATED | NCT05418673 |
| Placebo | Other | Phase PHASE1 | Amyotrophic Lateral Sclerosis | COMPLETED | NCT05006352 |
| DNL343 | Other | Phase PHASE1 | Amyotrophic Lateral Sclerosis | COMPLETED | NCT05006352 |
| No intervention | Other | Preclinical | Mucopolysaccharidosis III-A | COMPLETED | NCT05523206 |
| idursulfase | Other | Phase PHASE2 | Mucopolysaccharidosis II | RECRUITING | NCT05371613 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | RECRUITING | NCT05371613 |
| tividenofusp alfa | Other | Phase PHASE1 | Mucopolysaccharidosis II | ACTIVE_NOT_RECRUITING | NCT04251026 |
| BIIB122-Matching Placebo | Other | Phase PHASE2 | Parkinson Disease | ACTIVE_NOT_RECRUITING | NCT05348785 |
| BIIB122 | Other | Phase PHASE2 | Parkinson Disease | ACTIVE_NOT_RECRUITING | NCT05348785 |
| DNL126 | Other | Phase PHASE1 | Mucopolysaccharidosis Type IIIA | ACTIVE_NOT_RECRUITING | NCT06181136 |
| Placebo | Other | Phase PHASE1 | Frontotemporal Dementia | ACTIVE_NOT_RECRUITING | NCT05262023 |
| DNL593 | Other | Phase PHASE1 | Frontotemporal Dementia | ACTIVE_NOT_RECRUITING | NCT05262023 |
| DNL952 | Other | Phase PHASE1 | Late-onset Pompe Disease | NOT_YET_RECRUITING | NCT07354724 |
| Matching Placebo | Other | Phase PHASE2 | Amyotrophic Lateral Sclerosis | COMPLETED | NCT05842941 |
| DNL343 | Other | Phase PHASE2 | Amyotrophic Lateral Sclerosis | COMPLETED | NCT05842941 |
| BIIB122-Matching Placebo | Other | Phase PHASE2 | Parkinson Disease | RECRUITING | NCT06602193 |
| BIIB122 225 mg | Other | Phase PHASE2 | Parkinson Disease | RECRUITING | NCT06602193 |
| Placebo | Other | Phase PHASE1 | Alzheimer Disease, Early Onset | RECRUITING | NCT07328451 |
| DNL628 | Other | Phase PHASE1 | Alzheimer Disease, Early Onset | RECRUITING | NCT07328451 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| tividenofusp alfa | Other | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| DNL952 | DRUG | Phase PHASE1 | Late-onset Pompe Disease | NOT_YET_RECRUITING | NCT07354724 |
| DNL628 | DRUG | Phase PHASE1 | Alzheimer Disease, Early Onset | RECRUITING | NCT07328451 |
| BIIB122 225 mg | DRUG | Phase PHASE2 | Parkinson Disease | RECRUITING | NCT06602193 |
| [14C]-DNL343 | DRUG | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT06281158 |
| DNL126 | DRUG | Phase PHASE1 | Mucopolysaccharidosis Type IIIA | ACTIVE_NOT_RECRUITING | NCT06181136 |
| Matching Placebo | DRUG | Phase PHASE2 | Amyotrophic Lateral Sclerosis | COMPLETED | NCT05842941 |
| No intervention | OTHER | Preclinical | Mucopolysaccharidosis III-A | COMPLETED | NCT05523206 |
| DNL919 | DRUG | Phase PHASE1 | Healthy Participant | COMPLETED | NCT05450549 |
| idursulfase | DRUG | Phase PHASE2 | Mucopolysaccharidosis II | RECRUITING | NCT05371613 |
| BIIB122-Matching Placebo | OTHER | Phase PHASE2 | Parkinson Disease | RECRUITING | NCT06602193 |
| BIIB122 | DRUG | Phase PHASE3 | Parkinson Disease | TERMINATED | NCT05418673 |
| DNL593 | DRUG | Phase PHASE1 | Frontotemporal Dementia | ACTIVE_NOT_RECRUITING | NCT05262023 |
| [14C] BIIB122 ([14C] DNL151) | DRUG | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT05119790 |
| BIIB122 (DNL151) | DRUG | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT05005338 |
| DNL151 | DRUG | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04557800 |
| DNL343 | DRUG | Phase PHASE2 | Amyotrophic Lateral Sclerosis | COMPLETED | NCT05842941 |
| tividenofusp alfa | DRUG | Phase PHASE2 | Mucopolysaccharidosis II | ENROLLING_BY_INVITATION | NCT06075537 |
| No Intervention | OTHER | Preclinical | Mucopolysaccharidosis II | COMPLETED | NCT04007536 |
| DNL747 | DRUG | Phase PHASE1 | Alzheimer Disease | COMPLETED | NCT03757325 |
| Placebo | DRUG | Phase PHASE1 | Alzheimer Disease, Early Onset | RECRUITING | NCT07328451 |
| DNL201 | DRUG | Phase PHASE1 | Healthy Volunteers | COMPLETED | NCT04551534 |