---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000167"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-08-11T23:59:59+00:00"
generated_at: "2026-05-17T15:33:55.945954+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Denali Q2 net loss $124M; FDA priority review for Hunter syndrome BLA, DNL126 accelerated path aligned

## Summary
- FDA accepted tividenofusp alfa BLA for priority review; PDUFA target action date January 5, 2026.
- FDA agreed CSF HS may be surrogate endpoint for accelerated approval of DNL126 in Sanfilippo syndrome; Phase 1/2 nearing completion.
- Net loss $124.1M for Q2 2025 vs $99.0M in Q2 2024; R&D expenses $102.7M vs $91.4M.
- Cash, cash equivalents, and marketable securities $977.4M as of June 30, 2025.
- Preclinical ATV:Abeta data published in Science; company on track to file 1-2 IND applications in 2025.

## SEC filing metadata
- accession: 0001714899-25-000167
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-08-11T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000167/0001714899-25-000167-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000167/dnli-20250811.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000167
- JSON: https://secwatch.observer/filing/0001714899-25-000167.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000167.txt

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