---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000072"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-03-05T23:59:59+00:00"
generated_at: "2026-05-25T10:43:09.096365+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Further analyses of DNL343 in ALS show no NfL treatment effect; extension discontinued

## Summary
- Further analyses of Regimen G DNL343 showed no treatment effect on neurofilament light (NfL) biomarker over 24-week double-blind period.
- A subset completing additional 28-week open-label extension also showed no NfL effect.
- On Jan 6, 2025, Denali announced study did not meet primary endpoint of slowing ALS progression.
- Key secondary endpoints also not statistically different; active treatment extension for Regimen G discontinued.
- DNL343 safe and well tolerated; data to be presented at future medical meeting; future development assessed.

## SEC filing metadata
- accession: 0001714899-25-000072
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-03-05T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000072/0001714899-25-000072-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000072/dnli-20250305.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000072
- JSON: https://secwatch.observer/filing/0001714899-25-000072.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000072.txt

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