---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-160341"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2023-06-05T23:59:59+00:00"
generated_at: "2026-06-14T07:26:10.881755+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Denali and Biogen revise BIIB122 program; close Phase 3 LIGHTHOUSE, expand Phase 2b LUMA

## Summary
- Denali (DNLI) and Biogen (BIIB) plan to close the Phase 3 LIGHTHOUSE study of BIIB122 in LRRK2-mutation Parkinson's, expected completion 2031; enrolled patients may join LUMA.
- The Phase 2b LUMA study will be modified to include both idiopathic early-stage PD and LRRK2-mutation patients; total enrollment ~640 participants.
- This revision is not based on any safety or efficacy data from BIIB122 studies.
- LUMA is designed to support registration; Biogen will operationalize the study.
- The change aims to get an efficacy readout sooner in idiopathic PD and initial data in LRRK2-mutation PD.

## SEC filing metadata
- accession: 0001193125-23-160341
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2023-06-05T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000119312523160341/0001193125-23-160341-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000119312523160341/d447218d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-160341
- JSON: https://secwatch.observer/filing/0001193125-23-160341.json
- Plain text: https://secwatch.observer/filing/0001193125-23-160341.txt

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