{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-25-000209","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2025-12-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.241049+00:00","generated_at":"2026-05-16T14:51:02.995577+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Denali pipeline update: DNL952 on clinical hold; PDUFA date Apr 2026 for Hunter syndrome","bullets":["BLA for tividenofusp alfa (Hunter syndrome) under FDA review; PDUFA target action date April 5, 2026. Enrollment in Cohort A expected to complete Dec 2025.","DNL126 (MPS IIIA) Phase 1/2 on track for completion 2026; potential accelerated approval and commercial launch by end of 2027. Initial data at 2026 WORLD Symposium.","IND for DNL952 (Pompe) placed on clinical hold; FDA requested protocol amendments (lower starting dose, revised inclusion criteria). Denali has responded, minimal delays expected.","Phase 1b study of DNL628 (Alzheimer's) expected to begin 1H 2026; CTA submitted. Regulatory submission for DNL921 planned 1H 2026.","BIIB122 (Parkinson's) Phase 2b readout expected 2026. Eclitasertib (ulcerative colitis) Phase 2 data expected 1H 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-25-000209","json":"https://secwatch.observer/filing/0001714899-25-000209.json","markdown":"https://secwatch.observer/filing/0001714899-25-000209.md","text":"https://secwatch.observer/filing/0001714899-25-000209.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000209/0001714899-25-000209-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000209/dnli-20251204.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:51:02.995577+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"}