{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-25-000146","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2025-07-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.759725+00:00","generated_at":"2026-05-18T09:17:51.740391+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts Denali's BLA for tividenofusp alfa with Priority Review; PDUFA Jan 5, 2026","bullets":["FDA grants Priority Review for BLA seeking accelerated approval of tividenofusp alfa for Hunter syndrome (MPS II).","PDUFA target action date set for January 5, 2026.","Tividenofusp alfa is designed to deliver IDS enzyme across the blood-brain barrier using TransportVehicle platform.","BLA supported by Phase 1/2 data from 47 participants; ongoing Phase 2/3 COMPASS study for global approvals.","If approved, would be first new enzyme replacement therapy for Hunter syndrome in nearly two decades."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-25-000146","json":"https://secwatch.observer/filing/0001714899-25-000146.json","markdown":"https://secwatch.observer/filing/0001714899-25-000146.md","text":"https://secwatch.observer/filing/0001714899-25-000146.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000146/0001714899-25-000146-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000146/dnli-20250707.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T09:17:51.740391+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"}