---
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"
generated_at: "2026-10-14T21:20:04.485965+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA expands ANKTIVA plus BCG label to papillary-only BCG-unresponsive NMIBC, widening IBRX market

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-421820
- JSON: https://secwatch.observer/filing/0001193125-26-421820.json
- Plain text: https://secwatch.observer/filing/0001193125-26-421820.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.