Monitor FDA pre-submission meetings and any announced BLA timeline. The agreement strengthens ImmunityBio's BCG supply position, but regulatory approval is not guaranteed. Watch for Data Use Agreement with SWOG/NCI to support BLA.
Price Chart
Executive Summary
ImmunityBio entered an exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo-172 strain of BCG, securing a second potential source of BCG for bladder cancer treatment. The agreement provides exclusive U.S. rights with no upfront payment, and ImmunityBio will lead regulatory submissions and commercialization. Positive Phase III data from the SWOG S1602 trial supports non-inferiority versus TICE BCG, but the product remains investigational in the U.S.
Key Financial Metrics
Key Facts
- Exclusive U.S. development and supply agreement with Japan BCG Laboratory for Tokyo-172 BCG.
- No upfront or milestone payments; all vials for regulatory submission provided at no cost.
- ImmunityBio is sole BLA applicant and marketing authorization holder; 10-year term from FDA approval.
- SWOG S1602 Phase III trial demonstrated non-inferiority of Tokyo-172 BCG vs TICE BCG (HR 0.82, 95.8% CI 0.63-1.08).
- ImmunityBio now has two potential BCG sources: this agreement and ongoing partnership with Serum Institute of India for rBCG.
Financial Impact
No financial terms disclosed; no upfront payment. Potential future revenue stream if FDA-approved, but magnitude uncertain.
Risk Factors
- Tokyo-172 BCG is not FDA-approved; regulatory pathway uncertain.
- Competition from existing BCG products and other intravesical therapies.
- Reliance on JBL for manufacturing; supply chain risks.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-229153 |
| Document: d75270dex991.htm | 0001193125-26-229153 |
| Document: 0001193125-26-229153-index-headers.html | 0001193125-26-229153 |
| Document: 0001193125-26-229153-index.html | 0001193125-26-229153 |
| Document: 0001193125-26-229153.txt | 0001193125-26-229153 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 4, 2026 8w ago | 8-K | $6.95 $7.87 | ▲ +13.24% | ▲ +14.48% | $10.28 (+47.99%) |
Jul 6, 2026 12w ago | Insider Cluster | $8.91 $7.17 | ▼ −19.53% | ▼ −18.96% | $10.28 (+15.43%) |
Jul 1, 2026 13w ago | Insider Cluster | $9.20 $6.83 | ▼ −25.76% | ▼ −23.58% | $10.28 (+11.79%) |
May 18, 2026 19w ago | 8-K | $7.76 $6.99 | ▼ −9.92% | ▼ −10.91% | $10.28 (+32.54%) |
Apr 9, 2026 25w ago | 8-K | $7.48 $8.38 | ▲ +12.03% | ▲ +4.46% | $10.28 (+37.50%) |
Apr 6, 2026 25w ago | 8-K | $7.08 $7.43 | ▲ +4.94% | ▼ −4.04% | $10.28 (+45.27%) |
Feb 28, 2026 30w ago | Institutional Cluster | $10.44 $6.66 | ▼ −36.21% | ▼ −28.27% | $10.28 (−1.48%) |
US Market Status
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