secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2026-05-21T22:17:45+00:00
Accession:  0001714899-26-000070
Event type: other_material
Sentiment:  negative
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Denali & Biogen halt BIIB122 in idiopathic Parkinson's after Phase 2b miss; BEACON continues
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- Phase 2b LUMA study of BIIB122 (DNL151) in 648 early-stage Parkinson's patients failed primary and secondary endpoints.
- BIIB122 did not slow disease progression vs placebo on MDS-UPDRS Part II+III combined score.
- Biogen and Denali discontinue further development of BIIB122 in idiopathic Parkinson's disease.
- Denali continues independent Phase 2a BEACON study in LRRK2 pathogenic variant carriers; data expected H1 2027.
- Biomarker data showed >90% peripheral LRRK2 kinase inhibition and ~30% CSF pRab10 reduction.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489926000070/0001714899-26-000070-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489926000070/dnli-20260521.htm
  HTML page:      https://secwatch.observer/filing/0001714899-26-000070

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer