TLDR
- ImmunityBio’s ANKTIVA received EU conditional marketing authorization for BCG-unresponsive NMIBC, the first immunotherapy approved for this indication in Europe.
- The approval covers 30 EU/EEA countries, bringing ANKTIVA’s total reach to 33 countries across four regulatory jurisdictions.
- Clinical trial data showed a 71% complete response rate, with 84% of responders remaining cystectomy-free at 36 months.
- IBRX stock jumped more than 31% on the news, and is up over 200% year-to-date.
- ImmunityBio is not yet profitable, with ~$5.9B market cap and trailing revenue of $82.56 million.
ImmunityBio shares jumped more than 31% Wednesday after the European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
The approval is a first — no treatment had previously been authorized in Europe for this indication. Before ANKTIVA, patients faced radical bladder removal as their only option.
The authorization covers all 27 EU member states plus Iceland, Norway, and Liechtenstein, and follows earlier approvals in the U.S. (April 2024), UK (July 2025), and Saudi Arabia (January 2026). ANKTIVA is now authorized in 33 countries across four regulatory jurisdictions.
Strong Clinical Data Behind the Approval
The EU decision is backed by results from the QUILT-3.032 trial. ANKTIVA achieved a 71% complete response rate, with responses lasting up to 54-plus months.
The median duration of complete response was 26.6 months. Among responders, 84% remained cystectomy-free at 36 months.
Europe diagnoses more than 150,000 NMIBC patients annually. NMIBC accounts for roughly 75% of all bladder cancer cases, making the addressable market substantial.
The conditional authorization requires ImmunityBio to continue submitting long-term safety and efficacy data to the European Medicines Agency as a condition of maintaining the approval.
Expanding Pipeline and Analyst Confidence
H.C. Wainwright kept its Buy rating on IBRX and raised its price target to $10 following the EU news.
The FDA has also outlined a resubmission path for ANKTIVA in BCG-unresponsive papillary bladder cancer that would not require new clinical trials.
In Saudi Arabia, ImmunityBio is preparing a recombinant BCG regulatory package for the SFDA to help address a local BCG shortage, with submission expected in the coming weeks.
The company has also started a Phase 2 trial combining CD19-targeted NK cell therapy, ANKTIVA, and rituximab as a chemotherapy-free lymphoma treatment.
Financials: Growth but No Profit Yet
ImmunityBio carries a market cap of around $5.9 billion but has not yet reached profitability. Trailing revenue stands at $82.56 million, with a reported growth rate of 1,025% over the last twelve months.
The company holds a current ratio of 5.77, pointing to solid near-term liquidity. A $505 million convertible note with Nant Capital was amended to allow partial conversions into common stock.
IBRX is up more than 200% year-to-date heading into Wednesday’s close.
