TLDR
- The European Commission gave conditional approval to ANKTIVA in combination with BCG for BCG-unresponsive NMIBC – the first such authorization in Europe.
- The approval encompasses 30 European countries, enabling ANKTIVA to have a presence in 33 countries across four regulatory regions.
- The data from the QUILT-3.032 trial indicated a 71% complete response rate, and 84% of the responders were free of cystectomy at 36 months.
- On Wednesday, IBRX stock rose by over 31% and has increased by more than 200% since the start of the year.
- The company is still unprofitable, with trailing revenue of $82.56 million, but it reported a revenue growth of 1,025%.
On Wednesday, ImmunityBio shares went up by more than 31% after the European Commission granted the company a conditional marketing authorization for ANKTIVA, which is used together with BCG, for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
This is the first immunotherapy that Europe has ever authorized for this indication. Before this decision, patients in the region had no approved treatment options and had to undergo radical bladder removal as their only way forward.
The authorization covers all 27 EU member states, along with Iceland, Norway, and Liechtenstein. When combined with previous approvals in the U.S. (April 2024), UK (July 2025), and Saudi Arabia (January 2026), ANKTIVA is now approved in 33 countries across four regulatory regions.
Trial Results That Made the Case
The EU’s decision is based on the data from the QUILT-3.032 study. ANKTIVA achieved a 71% complete response rate, and the responses lasted for more than 54 months.
The median duration of the complete response was 26.6 months. Among those who responded, 84% remained free of cystectomy at the 36 – month mark.
More than 150,000 new NMIBC diagnoses are made in Europe each year. NMIBC accounts for approximately 75% of all bladder cancer cases on the continent.
must continue to provide long – term safety and efficacy data to the European Medicines Agency as part of the conditional authorization terms.
What Comes Next for ImmunityBio
Following the EU announcement, H.C. Wainwright raised its price target for IBRX to $10 and maintained its Buy rating.
The FDA has outlined a resubmission path for ANKTIVA in BCG-unresponsive papillary bladder cancer, eliminating the need for new clinical trials.
In Saudi Arabia, is preparing a recombinant BCG package for the SFDA to address the local BCG shortage, and the submission is expected soon.
A Phase 2 trial is also in progress to test a chemotherapy – free lymphoma combination – CD19 – targeted NK cell therapy, ANKTIVA, and rituximab.
Financials Still a Work in Progress
ImmunityBio’s market cap is approximately $5.9 billion, but the company has not yet made a profit. The trailing 12 – month revenue is $82.56 million, although the reported growth rate reached 1,025% during that period.
The liquidity seems stable, with a current ratio of 5.77. A $505 million convertible note with Nant Capital was recently amended to allow partial conversion into common stock.
As of Wednesday’s session, IBRX has gained more than 200% since the start of the year.
