{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-002995","form_type":"8-K","ticker":"IONS","cik":"0000874015","company_name":"IONIS PHARMACEUTICALS INC","filed_at":"2024-01-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:27.099437+00:00","generated_at":"2026-06-06T20:53:30.436138+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Ionis announces positive Phase 3 results for donidalorsen in HAE; NDA submission planned","bullets":["Donidalorsen met primary endpoint: significant reduction in HAE attack rate for Q4W (p<0.001) and Q8W (p=0.004) vs placebo.","Favorable safety profile; no serious adverse events in donidalorsen-treated patients.","Ionis preparing NDA submission to U.S. FDA; Otsuka preparing MAA to European Medicines Agency.","Third positive Phase 3 readout in 12 months, underscoring LICA platform strength.","Over 90% of OASIS-HAE patients completed and entered OASIS-Plus open-label extension study."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-002995","json":"https://secwatch.observer/filing/0001140361-24-002995.json","markdown":"https://secwatch.observer/filing/0001140361-24-002995.md","text":"https://secwatch.observer/filing/0001140361-24-002995.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/874015/000114036124002995/0001140361-24-002995-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/874015/000114036124002995/ef20019323_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T20:53:30.436138+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"}