{"schema_version":"secwatch.filing_event.v1","accession":"0001326110-25-000143","form_type":"8-K","ticker":"IBRX","cik":"0001326110","company_name":"ImmunityBio, Inc.","filed_at":"2025-12-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.107618+00:00","generated_at":"2026-05-16T13:20:19.827313+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"ImmunityBio receives EMA positive opinion for ANKTIVA+BCG in NMIBC CIS in Europe","bullets":["EMA recommends conditional marketing authorization for ANKTIVA+BCG to treat BCG-unresponsive NMIBC with CIS.","Decision based on single-arm trial: 71% complete response rate, median duration ~27 months (up to 54+ months).","Over 150,000 Europeans diagnosed with NMIBC annually; no authorized treatment currently for BCG-unresponsive cases.","Opinion forwarded to European Commission for final EU-wide approval; company to submit long-term follow-up data.","Six BCG strains available in Europe; ImmunityBio developing recombinant BCG to address U.S. shortages."],"urls":{"canonical":"https://secwatch.observer/filing/0001326110-25-000143","json":"https://secwatch.observer/filing/0001326110-25-000143.json","markdown":"https://secwatch.observer/filing/0001326110-25-000143.md","text":"https://secwatch.observer/filing/0001326110-25-000143.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1326110/000132611025000143/0001326110-25-000143-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1326110/000132611025000143/ibrx-20251212.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:20:19.827313+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"}