Company profile
DENALI THERAPEUTICS INC.
NASDAQ:DNLIBiotechnology: Biological Products (No Diagnostic Substances)
Drug pipeline (2)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| AVLAYAH | approved | $3.6MQ2 2026 | 0 | — |
| DNL-201 | phase1 | — | 2 | no active trials |
Revenue is the latest quarter the company reported for that product, from SEC filings; a fourth quarter is the year less nine months when no filing states one. Trial counts are of the product's ingredients, deduplicated by trial, so products sharing an ingredient share trials.
Clinical trials (18)
| NCT ID | Phase | Status | Start | Completion | Sponsor name | Title |
|---|---|---|---|---|---|---|
| NCT06281158 | phase1 | completed | 2024-03-01 | 2024-04-30 | Denali Therapeutics Inc. | A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants |
| NCT04251026 | phase1_2 | active_not_recruiting | 2020-07-16 | 2031-02-01 | Denali Therapeutics Inc. | A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome |
| NCT05371613 | phase2_3 | active_not_recruiting | 2022-07-21 | 2027-12-01 | Denali Therapeutics Inc. | 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) |
| NCT05006352 | phase1 | completed | 2021-08-11 | 2022-12-15 | Denali Therapeutics Inc. | A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis |
| NCT04581772 | phase1 | completed | 2020-12-23 | 2021-06-04 | Denali Therapeutics Inc. | A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers |
FDA applications (1)
| Application | Approved | Type | Applicant | Products | ||||
|---|---|---|---|---|---|---|---|---|
| BLA 761485 | 2026-03-24 | BLA | DENALI THERAPEUTICS INC. | |||||
Loading… | ||||||||