---
schema_version: "secwatch.filing_event.v1"
accession: "0001326110-26-000018"
form_type: "8-K"
ticker: "IBRX"
cik: "0001326110"
company_name: "ImmunityBio, Inc."
filed_at: "2026-02-18T23:59:59+00:00"
generated_at: "2026-05-16T01:58:20.256785+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# ImmunityBio gets EC approval for ANKTIVA+BCG in NMIBC CIS; now authorized in 33 countries

## Summary
- EC conditional marketing authorization for ANKTIVA+BCG in BCG-unresponsive NMIBC CIS; 71% complete response rate, median DOR 26.6 months.
- Approval covers all 27 EU member states plus Iceland, Norway, Liechtenstein; total authorized countries now 33.
- First immunotherapy authorized in Europe for this indication; prior standard of care was radical cystectomy.
- Authorization based on QUILT-3.032 phase 2/3 trial; ImmunityBio to submit long-term safety and efficacy data as condition.
- Global regulatory footprint built in under 2 years from initial FDA approval in April 2024.

## SEC filing metadata
- accession: 0001326110-26-000018
- form_type: 8-K
- ticker: IBRX
- cik: 0001326110
- company_name: ImmunityBio, Inc.
- filed_at: 2026-02-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1326110/000132611026000018/0001326110-26-000018-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1326110/000132611026000018/ibrx-20260218.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001326110-26-000018
- JSON: https://secwatch.observer/filing/0001326110-26-000018.json
- Plain text: https://secwatch.observer/filing/0001326110-26-000018.txt

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