{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-26-000004","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2026-01-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.984958+00:00","generated_at":"2026-05-16T11:32:50.514836+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Denali outlines 2026 milestones: PDUFA April 5 for Hunter syndrome, multiple pipeline readouts","bullets":["Preparing for commercial launch of tividenofusp alfa (Hunter syndrome) with PDUFA target action date April 5, 2026; results published in NEJM.","Expect multiple clinical data readouts: Phase 1/2 DNL126 for Sanfilippo type A, Phase 1/2 DNL593 for FTD-GRN, Phase 2b LUMA for Parkinson's (BIIB122).","Initiate Phase 1b for DNL628 (OTV:MAPT) in Alzheimer's; FDA lifted clinical hold on DNL952 for Pompe disease; Phase 1 start.","Completed equity financing (~$200M gross) and royalty funding from Royalty Pharma up to $275M; cash as of Sep 30, 2025: ~$872.9M.","Partnerships: Biogen (Parkinson's, 50/50 US), Takeda (FTD-GRN, 50/50 US), Sanofi (RIPK1 inhibitor in UC, royalties)."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-26-000004","json":"https://secwatch.observer/filing/0001714899-26-000004.json","markdown":"https://secwatch.observer/filing/0001714899-26-000004.md","text":"https://secwatch.observer/filing/0001714899-26-000004.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000004/0001714899-26-000004-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000004/dnli-20260106.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:32:50.514836+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"}