ImmunityBio Gains EU Approval for Anktiva Bladder Cancer Therapy, Expands to Saudi Arabia

The European Commission has granted conditional marketing authorization for ImmunityBio's immunotherapy Anktiva (nogapendekin alfa inbakicept) in combination with BCG for the treatment of adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors. The approval, dated February 16, 2026, marks the first authorized treatment in Europe for this specific bladder cancer condition, an area where patients previously faced radical cystectomy as their only alternative.

The authorization covers all 27 EU member states plus Iceland, Norway, and Liechtenstein. With this authorization, Anktiva is now approved across 33 countries spanning four regulatory jurisdictions, a global footprint built in under two years from its initial FDA approval in April 2024.

The European Commission's decision was based on results from the QUILT-3.032 study — a single-arm, open-label Phase 2/3 trial in 100 adults with BCG-unresponsive NMIBC CIS. The trial demonstrated a 71% complete response rate, a median duration of complete response of 26.6 months, and individual responses lasting up to 54 months and beyond. More than 80% of treated patients preserved their bladder through three years of follow-up.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion in December 2025, concluding that the benefits of early patient access outweighed the risks associated with the single-arm trial design. As a conditional authorization, ImmunityBio will be required to submit ongoing long-term safety and efficacy data to the EMA annually.

Bladder cancer is the fifth most common cancer in the EU, with more than 200,000 new cases expected in 2025 alone, approximately 75% of which are NMIBC. Prior to Anktiva's authorization, there were no approved therapies in the EU for patients whose disease failed BCG therapy. The company noted a supply advantage: unlike the US, which approves only one BCG strain, Europe has approved approximately six, providing a more reliable supply base for the Anktiva-BCG combination regimen.

Separately, ImmunityBio announced partnerships with Biopharma and Cigalah Healthcare to launch ANKTIVA in Saudi Arabia for bladder and lung cancer patients. Biopharma and Cigalah are two of the largest pharmaceutical commercial distributors in the Middle East and North Africa (MENA). The Registration Certificate of Pharmaceutical Product with pricing has been issued to ImmunityBio from the Saudi FDA, and ANKTIVA will be available for distribution within the next 60 days.

ImmunityBio established a wholly owned subsidiary in the Kingdom of Saudi Arabia to support physicians and healthcare systems throughout the MENA region. The company has initiated discussion with Saudi FDA and UAE regulatory authorities to expand ANKTIVA indications beyond lung and bladder cancer.

As of mid-morning trading on February 18, 2026, IBRX shares were trading at approximately $7.38, up $1.36 or roughly 22.6% on the day, after opening at $6.06 against a previous close of $6.02. The stock hit an intraday high of $7.21 early in the session before extending gains, with volume reaching over 12 million shares. The market capitalization surged to approximately $7.09 billion intraday. The stock has returned over 263% year-to-date and more than 114% over the trailing one-year period.

ImmunityBio reported trailing twelve-month revenue of $82.56 million against a net loss of $348.62 million, with an operating margin deeply negative at around -316%. The company holds $257.81 million in cash, and its gross margin of approximately 99.5% reflects strong product-level economics. With earnings expected March 2, 2026, investors will be watching closely for any updated commercial guidance in the wake of the EU approval.