{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-26-000020","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2026-02-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.985170+00:00","generated_at":"2026-05-15T23:41:38.611224+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 Q4 2025 net loss $128.5M; tividenofusp alfa PDUFA date April 5, 2026","bullets":["Q4 2025 net loss $128.5M vs $114.8M in Q4 2024; full year net loss $512.5M vs $422.8M in 2024.","PDUFA target action date for tividenofusp alfa (Hunter syndrome) BLA is April 5, 2026; commercial launch readiness established.","Preliminary Phase 1/2 data for DNL126 (Sanfilippo syndrome type A) support accelerated approval path; global Phase 3 planning ongoing.","Cash, cash equivalents and marketable securities as of Dec 31, 2025 were approximately $966.2M.","In December 2025, raised $275M synthetic royalty from Royalty Pharma and ~$200M net from public offering."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-26-000020","json":"https://secwatch.observer/filing/0001714899-26-000020.json","markdown":"https://secwatch.observer/filing/0001714899-26-000020.md","text":"https://secwatch.observer/filing/0001714899-26-000020.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000020/0001714899-26-000020-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000020/dnli-20260226.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T23:41:38.611224+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"}