{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-25-000072","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2025-03-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.563634+00:00","generated_at":"2026-05-25T10:43:09.096365+00:00","sec_items":["7.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Further analyses of DNL343 in ALS show no NfL treatment effect; extension discontinued","bullets":["Further analyses of Regimen G DNL343 showed no treatment effect on neurofilament light (NfL) biomarker over 24-week double-blind period.","A subset completing additional 28-week open-label extension also showed no NfL effect.","On Jan 6, 2025, Denali announced study did not meet primary endpoint of slowing ALS progression.","Key secondary endpoints also not statistically different; active treatment extension for Regimen G discontinued.","DNL343 safe and well tolerated; data to be presented at future medical meeting; future development assessed."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-25-000072","json":"https://secwatch.observer/filing/0001714899-25-000072.json","markdown":"https://secwatch.observer/filing/0001714899-25-000072.md","text":"https://secwatch.observer/filing/0001714899-25-000072.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000072/0001714899-25-000072-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000072/dnli-20250305.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T10:43:09.096365+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"}