{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-24-000065","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2024-02-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.222688+00:00","generated_at":"2026-06-06T00:17:21.103758+00:00","sec_items":["7.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Denali partner Sanofi reports Phase 2 ALS trial miss for RIPK1 inhibitor DNL788","bullets":["Phase 2 HIMALAYA study of SAR443820/DNL788 in ALS did not meet primary endpoint (ALSFRS-R).","Sanofi will present detailed efficacy and safety results at a future scientific forum.","DNL788 is an oral brain-penetrant RIPK1 inhibitor co-developed by Sanofi and Denali.","Sanofi will continue the K2 Phase 2 study of DNL788 in multiple sclerosis.","No financial terms disclosed; pipeline setback for Denali's key partnership."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-24-000065","json":"https://secwatch.observer/filing/0001714899-24-000065.json","markdown":"https://secwatch.observer/filing/0001714899-24-000065.md","text":"https://secwatch.observer/filing/0001714899-24-000065.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489924000065/0001714899-24-000065-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489924000065/dnli-20240216.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T00:17:21.103758+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"}