{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-25-000180","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2025-10-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.240595+00:00","generated_at":"2026-05-17T03:55:01.515884+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA extends Denali's PDUFA date for tividenofusp alfa to April 5, 2026","bullets":["FDA extended PDUFA target date from Jan 5 to April 5, 2026 for tividenofusp alfa BLA for Hunter syndrome.","Extension follows submission of updated clinical pharmacology info; FDA classified as Major Amendment.","Denali states extension not related to efficacy, safety, or biomarkers; no additional data requested.","Denali continues preparing for potential approval and commercial launch of tividenofusp alfa."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-25-000180","json":"https://secwatch.observer/filing/0001714899-25-000180.json","markdown":"https://secwatch.observer/filing/0001714899-25-000180.md","text":"https://secwatch.observer/filing/0001714899-25-000180.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000180/0001714899-25-000180-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000180/dnli-20251013.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:55:01.515884+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"}