---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000007"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-01-07T23:59:59+00:00"
generated_at: "2026-05-28T08:45:28.215155+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Denali's DNL343 fails Phase 2/3 ALS trial; primary endpoint not met

## Summary
- Primary endpoint of ALSFRS-R and survival at 24 weeks not met vs placebo.
- Key secondary endpoints (muscle strength, respiratory function) also not statistically different.
- DNL343 was safe and well tolerated overall.
- Additional analyses including NfL biomarkers and subgroup data expected later in 2025.
- Trial enrolled 186 DNL343-treated vs 139 placebo participants.

## SEC filing metadata
- accession: 0001714899-25-000007
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-01-07T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000007/0001714899-25-000007-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000007/dnli-20250106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000007
- JSON: https://secwatch.observer/filing/0001714899-25-000007.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000007.txt

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