{"schema_version":"secwatch.filing_event.v1","accession":"0001326110-23-000063","form_type":"8-K","ticker":"IBRX","cik":"0001326110","company_name":"ImmunityBio, Inc.","filed_at":"2023-05-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.404303+00:00","generated_at":"2026-06-15T03:43:15.134147+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA rejects ImmunityBio's BLA for Anktiva (N-803) in bladder cancer; CRL cites manufacturing issues","bullets":["FDA issued Complete Response Letter for Anktiva (N-803) + BCG in BCG-unresponsive NMIBC with CIS.","Deficiencies relate to pre-license inspection of third-party contract manufacturing and additional CMC issues.","No new preclinical or Phase 3 studies requested; FDA wants updated duration-of-response data and safety update.","Executive Chairman provides $30M non-convertible debt financing (SOFR+8%, matures Dec 31, 2023).","Partnering discussions for commercialization continue with a large biopharma; no assurance of completion."],"urls":{"canonical":"https://secwatch.observer/filing/0001326110-23-000063","json":"https://secwatch.observer/filing/0001326110-23-000063.json","markdown":"https://secwatch.observer/filing/0001326110-23-000063.md","text":"https://secwatch.observer/filing/0001326110-23-000063.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1326110/000132611023000063/0001326110-23-000063-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1326110/000132611023000063/ibrx-20230509.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-15T03:43:15.134147+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"}