secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2023-06-05T23:59:59+00:00
Accession:  0001193125-23-160341
Event type: other_material
Sentiment:  neutral
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000119312523160341/0001193125-23-160341-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000119312523160341/d447218d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-160341

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