secwatch.observer — SEC 8-K summary
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Issuer:     ImmunityBio, Inc. (IBRX)
CIK:        0001326110
Form:       8-K
Filed at:   2026-05-18T21:20:47+00:00
Accession:  0001193125-26-229153
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 1.01, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud

ImmunityBio signs exclusive U.S. supply agreement with Japan BCG Laboratory for Tokyo strain of BCG
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- Agreement grants ImmunityBio exclusive U.S. rights to develop and commercialize Tokyo-172 BCG for 10 years after FDA approval.
- Positive Phase III SWOG S1602 trial demonstrated non-inferiority of Tokyo strain vs TICE BCG in high-grade NMIBC (HR 0.82; 95.8% CI 0.63–1.08).
- ImmunityBio plans to engage FDA for BLA submission as sole applicant; no payment due until FDA approval; vials for regulatory submission provided at no cost.
- Agreement provides second BCG source alongside Serum Institute's rBCG; rBCG remains available to eligible patients under FDA Expanded Access Program.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1326110/000119312526229153/0001193125-26-229153-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1326110/000119312526229153/d75270d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-229153

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