---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-26-000004"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2026-01-06T23:59:59+00:00"
generated_at: "2026-05-16T11:32:50.514836+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Denali outlines 2026 milestones: PDUFA April 5 for Hunter syndrome, multiple pipeline readouts

## Summary
- Preparing for commercial launch of tividenofusp alfa (Hunter syndrome) with PDUFA target action date April 5, 2026; results published in NEJM.
- Expect multiple clinical data readouts: Phase 1/2 DNL126 for Sanfilippo type A, Phase 1/2 DNL593 for FTD-GRN, Phase 2b LUMA for Parkinson's (BIIB122).
- Initiate Phase 1b for DNL628 (OTV:MAPT) in Alzheimer's; FDA lifted clinical hold on DNL952 for Pompe disease; Phase 1 start.
- Completed equity financing (~$200M gross) and royalty funding from Royalty Pharma up to $275M; cash as of Sep 30, 2025: ~$872.9M.
- Partnerships: Biogen (Parkinson's, 50/50 US), Takeda (FTD-GRN, 50/50 US), Sanofi (RIPK1 inhibitor in UC, royalties).

## SEC filing metadata
- accession: 0001714899-26-000004
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2026-01-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489926000004/0001714899-26-000004-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489926000004/dnli-20260106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-26-000004
- JSON: https://secwatch.observer/filing/0001714899-26-000004.json
- Plain text: https://secwatch.observer/filing/0001714899-26-000004.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.