{"schema_version":"secwatch.filing_event.v1","accession":"0001326110-26-000018","form_type":"8-K","ticker":"IBRX","cik":"0001326110","company_name":"ImmunityBio, Inc.","filed_at":"2026-02-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.807290+00:00","generated_at":"2026-05-16T01:58:20.256785+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 gets EC approval for ANKTIVA+BCG in NMIBC CIS; now authorized in 33 countries","bullets":["EC conditional marketing authorization for ANKTIVA+BCG in BCG-unresponsive NMIBC CIS; 71% complete response rate, median DOR 26.6 months.","Approval covers all 27 EU member states plus Iceland, Norway, Liechtenstein; total authorized countries now 33.","First immunotherapy authorized in Europe for this indication; prior standard of care was radical cystectomy.","Authorization based on QUILT-3.032 phase 2/3 trial; ImmunityBio to submit long-term safety and efficacy data as condition.","Global regulatory footprint built in under 2 years from initial FDA approval in April 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001326110-26-000018","json":"https://secwatch.observer/filing/0001326110-26-000018.json","markdown":"https://secwatch.observer/filing/0001326110-26-000018.md","text":"https://secwatch.observer/filing/0001326110-26-000018.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1326110/000132611026000018/0001326110-26-000018-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1326110/000132611026000018/ibrx-20260218.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T01:58:20.256785+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"}