8-K
filed May 21, 2026, 6:17 PM ET
ticker DNLI
CIK 0001714899
other material
confidence high
sentiment negative
materiality 0.85
Denali & Biogen halt BIIB122 in idiopathic Parkinson's after Phase 2b miss; BEACON continues
Denali Therapeutics Inc.
- 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.
Machine-readable event card
- schema_version
- secwatch.filing_event.v1
- accession
- 0001714899-26-000070
- form_type
- 8-K
- ticker
- DNLI
- cik
- 0001714899
- company_name
- Denali Therapeutics Inc.
- filed_at
- 2026-05-21T22:17:45+00:00
- discovered_at
- 2026-05-22T10:05:00.289136+00:00
- generated_at
- 2026-05-22T10:10:12.641230+00:00
- sec_items
- ["7.01", "9.01"]
- event_type
- other_material
- sentiment
- negative
- materiality_score
- 0.85
- calibrated_materiality_score
- 0.85
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0001714899-26-000070
- json_url
- https://secwatch.observer/filing/0001714899-26-000070.json
- markdown_url
- https://secwatch.observer/filing/0001714899-26-000070.md
- text_url
- https://secwatch.observer/filing/0001714899-26-000070.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1714899/000171489926000070/0001714899-26-000070-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1714899/000171489926000070/dnli-20260521.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
- human_reviewed
- false
- corrected
- false
- correction_note
- null
- correction_timestamp
- null
- superseded_by
- null
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