TLDR
- The European Commission granted conditional marketing authorization for ImmunityBio’s ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with carcinoma in situ.
- ANKTIVA is the first immunotherapy approved in Europe for this indication, now authorized across 33 countries in four regulatory jurisdictions.
- The therapy showed a 71% complete response rate in trials, with 84% of responders remaining cystectomy-free at 36 months.
- IBRX stock jumped over 31% on the news, though shares had fallen nearly 8% in the prior week.
- ImmunityBio is not yet profitable, with a market cap of ~$5.9 billion and trailing revenue of $82.56 million.
ImmunityBio shares surged more than 31% Wednesday after the European Commission granted conditional marketing authorization for ANKTIVA, the company’s immunotherapy for a difficult-to-treat form of bladder cancer.
The approval covers adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ — a group of patients who, until now, had no authorized treatment in Europe outside of radical surgery.
The authorization applies across all 27 EU member states, plus Iceland, Norway, and Liechtenstein. That brings ANKTIVA’s total reach to 33 countries across four regulatory jurisdictions.
Prior approvals came from the U.S. in April 2024, the UK in July 2025, and Saudi Arabia in January 2026. The EU approval is the latest step in what has been a steady international rollout.
The authorization is conditional, meaning ImmunityBio must continue following up with trial participants and submit long-term safety and efficacy data to the European Medicines Agency.
What the Trial Data Shows
The approval is based on results from the QUILT-3.032 study. ANKTIVA posted a 71% complete response rate, with responses lasting up to 54-plus months.
The median duration of complete response was 26.6 months. Among those who responded, 84% remained cystectomy-free at 36 months — a meaningful result in a disease where bladder removal has historically been the fallback option.
More than 150,000 patients are diagnosed with NMIBC in Europe each year, making up roughly 75% of all bladder cancer cases on the continent.
ImmunityBio founder and executive chairman Dr. Patrick Soon-Shiong called the EU authorization “a defining moment” for patients who previously faced radical surgery as their only option.
Where the Company Stands Financially
Despite the regulatory wins, ImmunityBio is not yet profitable. The company carries a market cap of around $5.9 billion with trailing revenue of $82.56 million — though that revenue grew at a reported rate of 1,025% over the last twelve months.
The company has a current ratio of 5.77, which points to strong near-term liquidity. It operates with moderate debt levels.
ImmunityBio also has a $505 million convertible promissory note with Nant Capital that was amended to allow partial conversions into common stock.
H.C. Wainwright maintained a Buy rating and raised its price target to $10, citing positive momentum around ANKTIVA.
The FDA has also outlined a potential resubmission path for ANKTIVA in BCG-unresponsive papillary bladder cancer, which would not require new clinical trials.
In Saudi Arabia, ImmunityBio is working with the SFDA on a recombinant BCG regulatory package to address a BCG shortage, with a submission planned in coming weeks.
The company has also initiated a Phase 2 trial for a chemotherapy-free lymphoma therapy combining CD19-targeted NK cell therapy, ANKTIVA, and rituximab.
IBRX stock is up more than 200% year-to-date as of Wednesday’s close.
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