{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-035190","form_type":"8-K","ticker":"ROIV","cik":"0001635088","company_name":"Roivant Sciences Ltd.","filed_at":"2025-09-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.531270+00:00","generated_at":"2026-05-17T06:22:18.123335+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Roivant/Priovant: Phase 3 VALOR brepocitinib meets primary endpoint in dermatomyositis; NDA filing 1H 2026","bullets":["Brepocitinib 30 mg achieved week-52 mean TIS 46.5 vs placebo 31.2 (p=0.0006); all 9 key secondary endpoints met.","62% of brepocitinib patients on background steroids achieved steroid dose ≤2.5 mg/day vs 34% placebo; 42% off steroids vs 23%.","Safety profile consistent with prior brepocitinib trials; no increase in AESIs in active arm vs placebo.","NDA submission for brepocitinib in dermatomyositis planned for calendar first half 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-035190","json":"https://secwatch.observer/filing/0001140361-25-035190.json","markdown":"https://secwatch.observer/filing/0001140361-25-035190.md","text":"https://secwatch.observer/filing/0001140361-25-035190.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1635088/000114036125035190/0001140361-25-035190-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1635088/000114036125035190/ef20055655_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:22:18.123335+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"}