---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-24-000065"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2024-02-16T23:59:59+00:00"
generated_at: "2026-06-06T00:17:21.103758+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Denali partner Sanofi reports Phase 2 ALS trial miss for RIPK1 inhibitor DNL788

## Summary
- Phase 2 HIMALAYA study of SAR443820/DNL788 in ALS did not meet primary endpoint (ALSFRS-R).
- Sanofi will present detailed efficacy and safety results at a future scientific forum.
- DNL788 is an oral brain-penetrant RIPK1 inhibitor co-developed by Sanofi and Denali.
- Sanofi will continue the K2 Phase 2 study of DNL788 in multiple sclerosis.
- No financial terms disclosed; pipeline setback for Denali's key partnership.

## SEC filing metadata
- accession: 0001714899-24-000065
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2024-02-16T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489924000065/0001714899-24-000065-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489924000065/dnli-20240216.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-24-000065
- JSON: https://secwatch.observer/filing/0001714899-24-000065.json
- Plain text: https://secwatch.observer/filing/0001714899-24-000065.txt

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