{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-25-000054","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2025-01-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.563248+00:00","generated_at":"2026-05-28T03:36:42.588854+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Denali tividenofusp alfa gets FDA Breakthrough Therapy; BLA submission in early 2025","bullets":["FDA granted Breakthrough Therapy Designation for tividenofusp alfa in Hunter syndrome (MPS II) on Jan 7, 2025.","Denali expects BLA submission under accelerated approval pathway in early 2025; U.S. launch targeted late 2025/early 2026.","Seeking FDA alignment on accelerated approval for DNL126 in Sanfilippo syndrome after CSF HS normalization in Phase 1/2.","Cash, equivalents, and marketable securities ~$1.28B as of Sep 30, 2024; cash runway extended into 2028.","Plan to advance 1–2 TV-enabled programs into clinic per year over next three years across ETV, OTV, ATV."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-25-000054","json":"https://secwatch.observer/filing/0001714899-25-000054.json","markdown":"https://secwatch.observer/filing/0001714899-25-000054.md","text":"https://secwatch.observer/filing/0001714899-25-000054.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000054/0001714899-25-000054-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489925000054/dnli-20250113.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T03:36:42.588854+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"}