Denali Therapeutics Inc.
DNLIDrugs in Pipeline
5
Phase 3 Programs
2
Upcoming Catalysts
3
Next Catalyst
Aug 10, 2026
5wMarket Overview
Stock performance and key metrics
4 upcoming, 0 past
FDA PDUFA Date NEDD4-L inhibitor DNL310 (priority)
For Mucopolysaccharidosis Type II (MPS II). BLA filing. Extracted from SEC filing: 8-K
Source3 more catalysts beyond 14 days
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How DNLI's past catalysts played out
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)
Full breakdown — the signals behind the verdict
Frequently asked questions
What is in Denali Therapeutics Inc.'s drug pipeline?→
CatalystAlert tracks 5 drug candidates in Denali Therapeutics Inc.'s (DNLI) pipeline across Phase 3, Phase 2. Its lead program is idursulfase (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is Denali Therapeutics Inc.'s next FDA catalyst?→
Denali Therapeutics Inc.'s (DNLI) next tracked catalyst is a Earnings expected August 10, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track DNLI biotech catalysts?→
Add DNLI to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Denali Therapeutics Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.