secwatch.observer — SEC 8-K summary
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Issuer:     ImmunityBio, Inc. (IBRX)
CIK:        0001326110
Form:       8-K
Filed at:   2026-02-18T23:59:59+00:00
Accession:  0001326110-26-000018
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1326110/000132611026000018/0001326110-26-000018-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1326110/000132611026000018/ibrx-20260218.htm
  HTML page:      https://secwatch.observer/filing/0001326110-26-000018

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer