ImmunityBio (IBRX) Stock Jumps as EU Clears ANKTIVA for Bladder Cancer

TLDR

• European Commission granted conditional approval for ANKTIVA with BCG for BCG-unresponsive NMIBC — a first for Europe.
• Approval covers 30 European countries, taking ANKTIVA’s total to 33 countries in four regulatory jurisdictions.
• QUILT-3.032 71% complete response rate, 84% of responders cystectomy-free at 36 months.
• IBRX jumped 31% Wednesday, now up over 200% year-to-date.
• Company still unprofitable but posted 1,025% revenue growth on $82.56M trailing revenue.

ImmunityBio shares rose more than 31% Wednesday after the European Commission conditionally approved ANKTIVA, used with BCG, to treat adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

No treatment had ever been authorized in Europe for this patient group before. Those diagnosed previously had no approved options and were left facing radical bladder surgery.

The authorization covers all 27 EU member states plus Iceland, Norway, and Liechtenstein. ANKTIVA had already been approved in the U.S. (April 2024), UK (July 2025), and Saudi Arabia (January 2026), bringing its total cleared markets to 33 countries across four regulatory jurisdictions.

ImmunityBio, Inc., IBRX

The conditional approval requires ImmunityBio to keep submitting long-term safety and efficacy data to the European Medicines Agency.

The Numbers Behind the EU Decision

The European Commission based its decision on results from the QUILT-3.032 clinical trial.

ANKTIVA posted a 71% complete response rate. Responses lasted up to 54-plus months, with a median duration of 26.6 months.

Among patients who responded, 84% were still cystectomy-free at 36 months — a number that carries weight in a disease where bladder removal has long been the last resort.

Europe records more than 150,000 new NMIBC diagnoses each year, with NMIBC accounting for around 75% of all bladder cancer cases on the continent.

Analyst Reaction and Pipeline Progress

H.C. Wainwright lifted its price target on IBRX to $10 and held its Buy rating following the EU news.

The FDA has also signaled a potential resubmission path for ANKTIVA in BCG-unresponsive papillary bladder cancer, one that would not require additional clinical trials.

ImmunityBio is working on a recombinant BCG package for Saudi Arabia’s SFDA to address a local BCG shortage, with submission planned in the near term.

A Phase 2 trial is running for a chemotherapy-free lymphoma regimen combining CD19-targeted NK cell therapy, ANKTIVA, and rituximab — widening the potential use cases for the therapy.

Financial Snapshot

ImmunityBio’s market cap is roughly $5.9 billion. The company has not yet reached profitability, with trailing 12-month revenue of $82.56 million and a reported revenue growth rate of 1,025%.

Liquidity remains healthy with a current ratio of 5.77. A $505 million convertible note with Nant Capital was amended recently to permit partial conversion into common stock.

IBRX has added more than 200% year-to-date through Wednesday.

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