{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-25-000192","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2025-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.240739+00:00","generated_at":"2026-05-16T23:50:39.104690+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Denali Q3 net loss $126.9M; tividenofusp alfa PDUFA extended to April 2026","bullets":["Net loss $126.9M vs $107.2M in Q3 2024; cash $872.9M at Sept 30, 2025.","FDA extended PDUFA date for tividenofusp alfa BLA from Jan 5 to April 5, 2026; no new data requested.","Completed enrollment in Phase 1/2 study of DNL126 for MPS IIIA; planning global confirmatory study.","Submitted CTA for DNL628 (Alzheimer's) and IND for DNL952 (Pompe); new pipeline programs.","CMO Carole Ho departing; Peter Chin appointed Acting CMO; Tim Van Hauwermeiren joins Board."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-25-000192","json":"https://secwatch.observer/filing/0001714899-25-000192.json","markdown":"https://secwatch.observer/filing/0001714899-25-000192.md","text":"https://secwatch.observer/filing/0001714899-25-000192.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000192/0001714899-25-000192-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000192/dnli-20251106.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T23:50:39.104690+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"}