{"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","discovered_at":"2026-05-14T18:03:40.180344+00:00","generated_at":"2026-06-14T07:26:10.881755+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Denali and Biogen revise BIIB122 program; close Phase 3 LIGHTHOUSE, expand Phase 2b LUMA","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-160341","json":"https://secwatch.observer/filing/0001193125-23-160341.json","markdown":"https://secwatch.observer/filing/0001193125-23-160341.md","text":"https://secwatch.observer/filing/0001193125-23-160341.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T07:26:10.881755+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}