Denali Therapeutics Inc. (DNLI)
A+
Pipeline Grade
Financial Position (from SEC Filings)
$390.7M
Cash & Equivalents
$131.2M
Quarterly Burn Rate
9 mo
Est. Cash Runway
$4,076M
Market Cap
Estimated from most recent SEC quarterly filing. View SEC filings
Drug Pipeline (1 Assets)
| Drug | Phase | Indications |
|---|---|---|
|
TIVIDENOFUSP ALFA-EKNM
AVLAYAH |
APPROVED | Alzheimer Disease, Alzheimer Disease, Early Onset, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Healthy Participant, Healthy Volunteers, Late-onset Pompe Disease, Mucopolysaccharidosis II, Mucopolysaccharidosis III-A, Mucopolysaccharidosis Type IIIA, Parkinson Disease |
Upcoming Catalysts
| Date | Event | Drug |
|---|---|---|
| 2026-12-01 | Phase2 Readout | — |
| 2027-02-01 | Phase1 Readout | — |
| 2027-03-01 | Phase2 Readout | — |
| 2027-06-01 | Phase3 Readout | — |
Active Clinical Trials (8)
| NCT # | Title | Phase | Status | Enrollment |
|---|---|---|---|---|
| NCT05371613 | A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult P... | PHASE3 | Recruiting | 63 |
| NCT06075537 | An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants Wit... | PHASE3 | Enrolling By Invitation | 99 |
| NCT06602193 | Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) | PHASE2 | Active Not Recruiting | 50 |
| NCT06181136 | Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A) | PHASE2 | Active Not Recruiting | 20 |
| NCT04251026 | A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome | PHASE2 | Active Not Recruiting | 47 |
| NCT05262023 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants a... | PHASE2 | Active Not Recruiting | 85 |
| NCT07354724 | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset P... | PHASE1 | Recruiting | 32 |
| NCT07328451 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Earl... | PHASE1 | Recruiting | 68 |
Source: ClinicalTrials.gov. Trial status last updated by sponsor — may not reflect current state.
FDA-Related SEC Filings
| Date | Type | Description | Link |
|---|---|---|---|
| 2026-06-18 | 8-K | Denali Therapeutics Inc. (DNLI) (CIK 0001714899) - EX-99.1 | EDGAR |