TLDR
- The European Commission conditionally approved ANKTIVA plus BCG for BCG-unresponsive NMIBC — the first such authorization in Europe.
- The approval covers 30 European countries, giving ANKTIVA a footprint in 33 countries across four regulatory jurisdictions.
- QUILT-3.032 trial data showed a 71% complete response rate and 84% of responders cystectomy-free at 36 months.
- IBRX stock climbed over 31% Wednesday and is up more than 200% year-to-date.
- The company remains unprofitable with $82.56 million in trailing revenue but posted 1,025% revenue growth.
ImmunityBio shares climbed more than 31% Wednesday after the European Commission handed the company a conditional marketing authorization for ANKTIVA, used alongside BCG, for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
It is the first immunotherapy Europe has ever authorized for this indication. Before this decision, patients in the region had no approved treatment and faced radical bladder removal as their only path forward.
The authorization spans all 27 EU member states plus Iceland, Norway, and Liechtenstein. Combined with prior approvals in the U.S. (April 2024), UK (July 2025), and Saudi Arabia (January 2026), ANKTIVA is now cleared in 33 countries across four regulatory jurisdictions.
Trial Results That Made the Case
The EU decision rests on data from the QUILT-3.032 study. ANKTIVA delivered a 71% complete response rate, with responses holding up to 54-plus months.
Median duration of complete response came in at 26.6 months. Of those who responded, 84% remained cystectomy-free at the 36-month mark.
Europe sees more than 150,000 new NMIBC diagnoses each year. NMIBC makes up around 75% of all bladder cancer cases on the continent.
ImmunityBio must continue providing long-term safety and efficacy data to the European Medicines Agency as part of the conditional authorization terms.
What Comes Next for ImmunityBio
H.C. Wainwright raised its price target on IBRX to $10 and kept its Buy rating following the EU announcement.
The FDA has outlined a resubmission path for ANKTIVA in BCG-unresponsive papillary bladder cancer that skips the need for new clinical trials.
In Saudi Arabia, ImmunityBio is putting together a recombinant BCG package for the SFDA to address a local BCG shortage, with submission expected soon.
A Phase 2 trial is also underway testing a chemotherapy-free lymphoma combination — CD19-targeted NK cell therapy, ANKTIVA, and rituximab.
Financials Still a Work in Progress
ImmunityBio’s market cap sits at roughly $5.9 billion, but the company has not turned a profit. Trailing 12-month revenue is $82.56 million, though the reported growth rate hit 1,025% over that period.
Liquidity looks solid 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.
IBRX has gained more than 200% year-to-date through Wednesday’s session.
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