{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-23-045178","form_type":"8-K","ticker":"ROIV","cik":"0001635088","company_name":"Roivant Sciences Ltd.","filed_at":"2023-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.636237+00:00","generated_at":"2026-06-10T08:41:05.455280+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Immunovant announces positive initial Phase 1 data for IMVT-1402; IgG reduction without albumin or LDL-C changes","bullets":["SC doses of IMVT-1402 achieved peak IgG reductions similar to batoclimab with no decrease in serum albumin or increase in LDL-C.","In 300 mg MAD cohort, mean total IgG reduction from baseline was 63% after 4 weekly doses; no albumin drop or LDL-C rise observed.","All adverse events were mild or moderate; no significant albumin reduction or LDL-C increase at any timepoint (all p>0.05).","Dosing for 600 mg MAD cohort has recently begun; additional MAD data expected in November 2023.","IMVT-1402 delivered as simple 2 mL SC injection at 150 mg/mL; SAD data showed potency similar to or greater than batoclimab."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-23-045178","json":"https://secwatch.observer/filing/0001140361-23-045178.json","markdown":"https://secwatch.observer/filing/0001140361-23-045178.md","text":"https://secwatch.observer/filing/0001140361-23-045178.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1635088/000114036123045178/0001140361-23-045178-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1635088/000114036123045178/ef20011235_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T08:41:05.455280+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"}