{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-25-000167","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2025-08-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.759920+00:00","generated_at":"2026-05-17T15:33:55.945954+00:00","sec_items":["2.02","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Denali Q2 net loss $124M; FDA priority review for Hunter syndrome BLA, DNL126 accelerated path aligned","bullets":["FDA accepted tividenofusp alfa BLA for priority review; PDUFA target action date January 5, 2026.","FDA agreed CSF HS may be surrogate endpoint for accelerated approval of DNL126 in Sanfilippo syndrome; Phase 1/2 nearing completion.","Net loss $124.1M for Q2 2025 vs $99.0M in Q2 2024; R&D expenses $102.7M vs $91.4M.","Cash, cash equivalents, and marketable securities $977.4M as of June 30, 2025.","Preclinical ATV:Abeta data published in Science; company on track to file 1-2 IND applications in 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-25-000167","json":"https://secwatch.observer/filing/0001714899-25-000167.json","markdown":"https://secwatch.observer/filing/0001714899-25-000167.md","text":"https://secwatch.observer/filing/0001714899-25-000167.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000167/0001714899-25-000167-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000167/dnli-20250811.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T15:33:55.945954+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"}