{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-032176","form_type":"8-K","ticker":"IONS","cik":"0000874015","company_name":"IONIS PHARMACEUTICALS INC","filed_at":"2025-08-21T23:59:59+00:00","discovered_at":"2026-05-14T18:02:46.534315+00:00","generated_at":"2026-05-17T11:00:42.283685+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Ionis' DAWNZERA (donidalorsen) for HAE prophylaxis in patients 12+","bullets":["First and only RNA-targeted HAE medicine; self-administered every 4 or 8 weeks via autoinjector.","Phase 3 OASIS-HAE: Q4W reduced monthly attack rate 81% vs placebo (primary endpoint); 87% from second dose.","OASISplus OLE: 94% attack rate reduction after one year; switch cohort reduced attacks 62% vs prior therapy.","Ionis' second independent launch in nine months; 84% of patients surveyed preferred DAWNZERA over prior treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-032176","json":"https://secwatch.observer/filing/0001140361-25-032176.json","markdown":"https://secwatch.observer/filing/0001140361-25-032176.md","text":"https://secwatch.observer/filing/0001140361-25-032176.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/874015/000114036125032176/0001140361-25-032176-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/874015/000114036125032176/ef20054334_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:00:42.283685+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"}