---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-22-000105"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2022-07-05T23:59:59+00:00"
generated_at: "2026-06-24T21:22:08.185538+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Denali receives CTA clearance for DNL919 Phase 1 study; FDA clinical hold remains unresolved

## Summary
- Denali receives CTA clearance to initiate Phase 1 study of DNL919 (ATV:TREM2) in healthy volunteers in the Netherlands.
- Phase 1 single ascending dose study expected to start in Q3 2022.
- FDA clinical hold on DNL919 IND remains; Denali has not yet submitted response.
- Continues engagement with FDA and European regulators to define path forward, including Phase 1b in Alzheimer's.

## SEC filing metadata
- accession: 0001714899-22-000105
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2022-07-05T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489922000105/0001714899-22-000105-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489922000105/dnli-20220704.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-22-000105
- JSON: https://secwatch.observer/filing/0001714899-22-000105.json
- Plain text: https://secwatch.observer/filing/0001714899-22-000105.txt

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