{"schema_version":"secwatch.filing_event.v1","accession":"0001764013-21-000129","form_type":"8-K","ticker":"IMVT","cik":"0001764013","company_name":"Immunovant, Inc.","filed_at":"2021-12-30T23:59:59+00:00","discovered_at":"2026-05-14T18:04:14.032270+00:00","generated_at":"2026-06-27T21:42:35.578520+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Immunovant achieves FDA alignment to start Phase 3 trial for batoclimab in MG in 1H 2022","bullets":["FDA Division of Neurology 1 agreed to move forward; Phase 3 for batoclimab in myasthenia gravis starts 1H 2022.","Trial includes induction with 680mg and 340mg weekly subQ doses; primary efficacy: MG-ADL in AChR+ subjects at 12 weeks.","Follow-on periods will explore alternative dosing (lower maintenance, higher rescue). Safety database per FDA guidance.","Data readout expected in 2024; investor call scheduled for January 5, 2022 at 8 a.m. ET."],"urls":{"canonical":"https://secwatch.observer/filing/0001764013-21-000129","json":"https://secwatch.observer/filing/0001764013-21-000129.json","markdown":"https://secwatch.observer/filing/0001764013-21-000129.md","text":"https://secwatch.observer/filing/0001764013-21-000129.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1764013/000176401321000129/0001764013-21-000129-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1764013/000176401321000129/imvt-20211230.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-27T21:42:35.578520+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"}