secwatch.observer — SEC 8-K summary ====================================== Issuer: Denali Therapeutics Inc. (DNLI) CIK: 0001714899 Form: 8-K Filed at: 2024-02-16T23:59:59+00:00 Accession: 0001714899-24-000065 Event type: other_material Sentiment: negative Materiality: 0.80 Item codes: 7.01 LLM model: deepseek-v4-flash:cloud@v2 Denali partner Sanofi reports Phase 2 ALS trial miss for RIPK1 inhibitor DNL788 ------------------------------------------------------------------------------- - 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. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489924000065/0001714899-24-000065-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1714899/000171489924000065/dnli-20240216.htm HTML page: https://secwatch.observer/filing/0001714899-24-000065 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer