{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-048238","form_type":"8-K","ticker":"ROIV","cik":"0001635088","company_name":"Roivant Sciences Ltd.","filed_at":"2024-12-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.052800+00:00","generated_at":"2026-05-29T09:52:45.708427+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Roivant: Phase 2 namilumab study fails in sarcoidosis; development discontinued","bullets":["Namilumab failed to meet the primary endpoint (proportion of subjects with a Rescue Event) in chronic active pulmonary sarcoidosis.","Secondary endpoints (FVC, corticosteroid tapering, King's Sarcoidosis Questionnaire) also showed no treatment benefit.","Safety profile remained consistent with prior studies; no new safety signals emerged.","Kinevant will discontinue further development of namilumab for sarcoidosis and plans to publish study results.","Roivant CEO Matt Gline acknowledged the failure but highlighted other program successes and continued clinical risk-taking."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-048238","json":"https://secwatch.observer/filing/0001140361-24-048238.json","markdown":"https://secwatch.observer/filing/0001140361-24-048238.md","text":"https://secwatch.observer/filing/0001140361-24-048238.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1635088/000114036124048238/0001140361-24-048238-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1635088/000114036124048238/ef20039426_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T09:52:45.708427+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"}