{"schema_version":"secwatch.filing_event.v1","accession":"0001326110-26-000004","form_type":"8-K","ticker":"IBRX","cik":"0001326110","company_name":"ImmunityBio, Inc.","filed_at":"2026-01-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.806681+00:00","generated_at":"2026-05-16T10:19:41.262292+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":"Saudi FDA grants accelerated approval for ImmunityBio's ANKTIVA in NSCLC and NMIBC","bullets":["SFDA approved ANKTIVA + checkpoint inhibitor for metastatic NSCLC after standard-of-care failure; first worldwide approval for this subcutaneous IL-15 agonist.","Approval based on QUILT-3.055 and QUILT-2.023 showing lymphocyte recovery and survival association; confirmatory trial ResQ-201A recruiting.","SFDA also approved ANKTIVA + BCG for BCG-unresponsive NMIBC with CIS, adding to U.S., U.K., and conditional EU approvals.","ImmunityBio plans regional office in Saudi Arabia and partner Biopharma Cigalah for MENA commercial distribution; NMIBC trial enrollment ahead of schedule, BLA submission by year-end."],"urls":{"canonical":"https://secwatch.observer/filing/0001326110-26-000004","json":"https://secwatch.observer/filing/0001326110-26-000004.json","markdown":"https://secwatch.observer/filing/0001326110-26-000004.md","text":"https://secwatch.observer/filing/0001326110-26-000004.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1326110/000132611026000004/0001326110-26-000004-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1326110/000132611026000004/ibrx-20260114.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T10:19:41.262292+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"}