{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-040507","form_type":"8-K","ticker":"ROIV","cik":"0001635088","company_name":"Roivant Sciences Ltd.","filed_at":"2024-09-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.888766+00:00","generated_at":"2026-05-31T05:55:17.573333+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Roivant/Immunovant: Phase 2a batoclimab 76% response in GD; pivotal IMVT-1402 trial by year end","bullets":["High-dose batoclimab (680mg SC weekly) achieved 76% response rate and 56% ATD-free response in uncontrolled GD at week 12.","Mean IgG reduction of 77% correlated with clinical outcomes; ≥70% IgG reduction yielded 60% ATD-free response vs 23%.","FDA cleared IND for IMVT-1402; pivotal trial in Graves' Disease expected to initiate by December 31, 2024.","Real-world data shows 25-30% of GD patients per year are uncontrolled on ATDs, representing a large commercial opportunity."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-040507","json":"https://secwatch.observer/filing/0001140361-24-040507.json","markdown":"https://secwatch.observer/filing/0001140361-24-040507.md","text":"https://secwatch.observer/filing/0001140361-24-040507.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1635088/000114036124040507/0001140361-24-040507-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1635088/000114036124040507/ef20035648_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T05:55:17.573333+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"}