ImmunityBio Shares Surge on European Regulatory and Commercial Milestones

ImmunityBio's stock surged over 40% after EU approval for its bladder cancer drug ANKTIVA and new commercial deals in Europe and the Middle East.

ImmunityBio's stock price experienced a dramatic rally this week, climbing over 40% to reach a new 52-week high. This surge was fueled by a pair of significant announcements: the granting of European marketing authorization for its immunotherapy ANKTIVA and the concurrent establishment of key commercial partnerships across Europe and the Middle East.

Stock Performance and Legal Note

The market reaction to the European Commission's decision was immediate and powerful. On February 18, shares opened at $6.06 and closed at $8.54, representing a single-day gain of approximately 41%. Trading continued actively the following day, with the stock reaching an intraday high of $8.95 before settling at $8.61. Trading volume exceeded 55 million shares.

In a separate development on February 17, the law firm Pomerantz LLP announced it is investigating claims on behalf of investors regarding whether ImmunityBio and certain of its officers or directors have engaged in securities fraud or other unlawful business practices. The announcement did not specify any concrete allegations or findings.

The company had previously reported preliminary 2025 net sales of $113 million, marking a 700% year-over-year increase.

European Approval Opens a Major New Market

A landmark regulatory decision was reached on February 18, 2026. The European Commission granted conditional marketing authorization for ANKTIVA (Nogapendekin Alfa Inbakicept) in combination with BCG. This therapy is approved for the treatment of BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The authorization is valid across all 27 European Union member states, as well as Iceland, Norway, and Liechtenstein.

This approval makes ANKTIVA the first immunotherapy of its kind licensed in Europe for this specific indication. Clinical trial data underpinning the decision showed a complete response rate of 71%. The median duration of response was 26.6 months, with some individual patients responding to the therapy for 54 months or longer.

With this latest authorization, ANKTIVA is now commercially available in 33 countries spanning four major regulatory jurisdictions: the United States (FDA approval in April 2024), the United Kingdom (MHRA approval in July 2025), Saudi Arabia (SFDA approval in January 2026), and the European Union.

Building a Commercial Infrastructure in Europe

To capitalize on the EU approval, ImmunityBio swiftly moved to secure a distribution network. On February 19, the company announced a partnership with Accord Healthcare. Accord will deploy over 100 personnel specializing in sales, medical affairs, and marketing to commercialize ANKTIVA throughout the United Kingdom, the EU, and EFTA states.

Supporting this effort, ImmunityBio has established a new Irish subsidiary based in Dublin. The addressable patient population in these regions is substantial, with approximately 157,000 people diagnosed annually with non-muscle invasive bladder cancer. An estimated 10 to 20 percent of these cases present the specific BCG-unresponsive indication for which ANKTIVA is now approved.

Strategic Expansion into the Middle East

The company's global commercial rollout continued on February 20 with a partnership announcement for the Middle East. ImmunityBio has teamed with Biopharma and Cigalah Healthcare—two of the region's largest pharmaceutical distributors—to launch ANKTIVA in Saudi Arabia. The therapy is slated for use in both bladder and lung cancer patients there. The company has also established a wholly-owned subsidiary in Saudi Arabia to support operations.

ANKTIVA is expected to be available in the Saudi market within 60 days. The Saudi Food and Drug Authority (SFDA) has issued a product registration with a set price. Notably, the Saudi approval covers two distinct indications: the BCG-combination therapy for non-muscle invasive bladder cancer, and for metastatic non-small cell lung cancer in combination with a checkpoint inhibitor.

ImmunityBio has already initiated discussions with regulatory authorities in Saudi Arabia and the United Arab Emirates to explore expanding ANKTIVA's approved uses beyond lung and bladder cancers.

Path Forward and Ongoing Development

These developments mark ImmunityBio's evolution from a U.S.-centric biotech firm into a global oncology-focused enterprise. A critical next phase in Europe will involve securing pricing and reimbursement agreements in individual national markets, a process that typically spans several months.

Concurrently, the company is progressing other regulatory pathways. It is preparing a response to the U.S. FDA regarding a potential label expansion for ANKTIVA in BCG-unresponsive papillary non-muscle invasive bladder cancer. Furthermore, patient recruitment is nearing full completion for a randomized study involving BCG-naïve patients.