{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-028247","form_type":"8-K","ticker":"IONS","cik":"0000874015","company_name":"IONIS PHARMACEUTICALS INC","filed_at":"2024-05-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:22.233840+00:00","generated_at":"2026-06-01T07:18:19.376834+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 reports positive Phase 3 results for donidalorsen in HAE; 81% attack reduction vs placebo","bullets":["Donidalorsen met primary endpoint: 81% lower monthly HAE attack rate with Q4W dosing vs placebo (p<0.001) over 24 weeks.","OASISplus OLE showed continued improvement: 93% (Q4W) and 92% (Q8W) attack rate reduction from baseline after one year.","Switch cohort: patients switching from prior prophylactic to donidalorsen had 62% further reduction in mean monthly attack rates; 84% preferred donidalorsen.","Donidalorsen was well-tolerated; no related serious TEAEs. Injection site reactions most common AE.","Ionis plans to file NDA with FDA this year; Otsuka preparing MAA in Europe for donidalorsen."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-028247","json":"https://secwatch.observer/filing/0001140361-24-028247.json","markdown":"https://secwatch.observer/filing/0001140361-24-028247.md","text":"https://secwatch.observer/filing/0001140361-24-028247.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/874015/000114036124028247/0001140361-24-028247-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/874015/000114036124028247/ef20030319_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T07:18:19.376834+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"}