Denali Therapeutics Inc.
DNLIDrugs in Pipeline
5
Phase 3 Programs
2
Upcoming Catalysts
3
Next Catalyst
Apr 30, 2026
4wMarket Overview
Stock performance and key metrics
6 upcoming, 1 past
FDA PDUFA Date - Tivi
Denali Therapeutics expects an FDA decision on April 5, 2026 for Tivi, with the company preparing launch plans and advancing pipeline catalysts ahead of the decision.
5 more catalysts beyond 14 days
Start a 48h free trial to see all upcoming catalysts
idursulfase
Mucopolysaccharidosis II
tividenofusp alfa
Mucopolysaccharidosis II
DNL126
Mucopolysaccharidosis Type IIIA
DNL593
Frontotemporal Dementia
BIIB122 225 mg
Parkinson Disease
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
idursulfase | Phase 3 | Mucopolysaccharidosis II | - | - |
tividenofusp alfa | Phase 3 | Mucopolysaccharidosis II | - | - |
DNL126 | Phase 2 | Mucopolysaccharidosis Type IIIA | - | - |
DNL593 | Phase 2 | Frontotemporal Dementia | - | - |
BIIB122 225 mg | Phase 2 | Parkinson Disease | - | - |
Mucopolysaccharidosis II
2 drugs in this indication
Mucopolysaccharidosis Type IIIA
1 drug in this indication
Frontotemporal Dementia
1 drug in this indication
Parkinson Disease
1 drug in this indication
Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)