{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-034854","form_type":"8-K","ticker":"ROIV","cik":"0001635088","company_name":"Roivant Sciences Ltd.","filed_at":"2026-08-28T20:31:33+00:00","discovered_at":"2026-08-28T20:34:00.495108+00:00","generated_at":"2026-08-28T20:34:29.316375+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA approves Roivant's LISRAYA (brepocitinib) for dermatomyositis at $35K WAC","bullets":["FDA granted approval of LISRAYA (brepocitinib) for adult dermatomyositis on Aug 28, 2026.","Wholesale acquisition cost set at $35,000 per 30-count bottle of 30 mg tablets.","No additional financial or commercial launch details disclosed in the filing."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-034854","json":"https://secwatch.observer/filing/0001140361-26-034854.json","markdown":"https://secwatch.observer/filing/0001140361-26-034854.md","text":"https://secwatch.observer/filing/0001140361-26-034854.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1635088/000114036126034854/0001140361-26-034854-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1635088/000114036126034854/ef20081283_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-28T20:34:29.316375+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"}