{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-112057","form_type":"8-K","ticker":"IBRX","cik":"0001326110","company_name":"ImmunityBio, Inc.","filed_at":"2025-05-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.936410+00:00","generated_at":"2026-05-22T16:48:50.591956+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"ImmunityBio receives FDA refusal to file for ANKTIVA sBLA in NMIBC papillary indication","bullets":["FDA issued Refusal to File (RTF) letter on May 2, 2025 for sBLA of ANKTIVA+BCG in BCG-unresponsive papillary NMIBC.","Company cites unanimous January 2025 FDA leadership guidance encouraging sBLA submission; RTF called inconsistent.","Existing approval for CIS +/- papillary (Cohort A) is unaffected; RTF pertains to papillary without CIS (Cohort B).","Data highlighted: 96% disease-specific survival at 36 months and >82% bladder-sparing rate in the papillary cohort.","Company requests urgent Type A meeting with FDA; former FDA Principal Deputy Commissioner Dr. Sherman supports appeal."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-112057","json":"https://secwatch.observer/filing/0001193125-25-112057.json","markdown":"https://secwatch.observer/filing/0001193125-25-112057.md","text":"https://secwatch.observer/filing/0001193125-25-112057.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1326110/000119312525112057/0001193125-25-112057-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1326110/000119312525112057/d949868d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T16:48:50.591956+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"}