{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-034735","form_type":"8-K","ticker":"ROIV","cik":"0001635088","company_name":"Roivant Sciences Ltd.","filed_at":"2026-08-27T21:24:44+00:00","discovered_at":"2026-08-27T21:26:31.592800+00:00","generated_at":"2026-08-27T21:26:35.957647+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"FDA approves Roivant's LISRAYA (brepocitinib) for dermatomyositis; now available in U.S.","bullets":["FDA approved LISRAYA (brepocitinib) 30 mg once-daily for adults with dermatomyositis; first targeted therapy approved for DM.","In Phase 3 VALOR trial, 55% on LISRAYA achieved moderate/better improvement plus minimal/no steroid use vs 30% on placebo at 52 weeks.","62% on LISRAYA tapered to minimal/no steroids vs 38% on placebo; 45% came off steroids entirely vs 29% on placebo.","LISRAYA is available immediately in U.S.; eligible patients may pay as little as $0/month via My Compass Support program.","Investor call scheduled for August 28, 2026 at 8:00 a.m. ET to discuss the approval and pipeline updates."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-034735","json":"https://secwatch.observer/filing/0001140361-26-034735.json","markdown":"https://secwatch.observer/filing/0001140361-26-034735.md","text":"https://secwatch.observer/filing/0001140361-26-034735.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1635088/000114036126034735/0001140361-26-034735-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1635088/000114036126034735/ef20081229_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-27T21:26:35.957647+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"}