{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-421820","form_type":"8-K","ticker":"IBRX","cik":"0001326110","company_name":"ImmunityBio, Inc.","filed_at":"2026-10-14T21:19:04+00:00","discovered_at":"2026-10-14T21:20:00.274555+00:00","generated_at":"2026-10-14T21:20:04.485965+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA expands ANKTIVA plus BCG label to papillary-only BCG-unresponsive NMIBC, widening IBRX market","bullets":["FDA expanded ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG to treat BCG-unresponsive NMIBC with papillary-only tumors; first approval for this population.","Papillary disease is ~85% of NMIBC patients; NMIBC is ~80% of US bladder cancer diagnoses, materially expanding IBRX's US addressable population.","QUILT-3.032 Cohort A: 62% of 77 patients achieved complete response (95% CI 51-73); 58% maintained response >=12 months, 40% >=24 months.","Builds on April 2024 approval covering CIS with or without papillary tumors; label now covers all BCG-unresponsive NMIBC patients.","Most common TRAEs were instillation-related (dysuria, pollakiuria, hematuria), mostly grade 1-2; label warns delaying cystectomy can risk metastatic disease."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-421820","json":"https://secwatch.observer/filing/0001193125-26-421820.json","markdown":"https://secwatch.observer/filing/0001193125-26-421820.md","text":"https://secwatch.observer/filing/0001193125-26-421820.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1326110/000119312526421820/0001193125-26-421820-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1326110/000119312526421820/d188887d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-14T21:20:04.485965+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"}