---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-23-000103"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2023-06-20T23:59:59+00:00"
generated_at: "2026-06-13T21:28:07.452059+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Denali reports 64% reduction in NfL with DNL310 in MPS II after 2 years

## Summary
- Mean serum NfL reduction of 64% (p<0.001) from baseline at 2 years in Phase 1/2 study (n=13).
- FDA recommended assessment of NfL as a possible biomarker in neuronopathic MPS II.
- Additional interim data from Phase 1/2 to be presented at SSIEM symposium in August 2023.
- Global Phase 2/3 COMPASS study of DNL310 ongoing; management hosted investor webinar June 20.

## SEC filing metadata
- accession: 0001714899-23-000103
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2023-06-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489923000103/0001714899-23-000103-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489923000103/dnli-20230620.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-23-000103
- JSON: https://secwatch.observer/filing/0001714899-23-000103.json
- Plain text: https://secwatch.observer/filing/0001714899-23-000103.txt

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