ImmunityBio Secures Dual Commercial Deals Following European Approval

ImmunityBio announces two major distribution deals for ANKTIVA in Europe and the Middle East following EU market authorization, driving stock gains and global expansion.

ImmunityBio is rapidly executing its commercial strategy, announcing two significant distribution partnerships within days of receiving European Union market authorization for its cancer therapy, ANKTIVA. This swift action underscores the company's focused drive to capitalize on recent regulatory successes.

Stock Performance and Market Context

ImmunityBio shares closed at $8.70 on February 20. The stock had surged approximately 42% on February 18, the day of the EU approval, jumping from $6.02 to $8.54. During the February 20 trading session, the equity reached a new 52-week intraday high of $9.25. Over the past twelve months, the share price has ranged from a low of $1.83 to the recent peak. The company's market capitalization stands at approximately $8.57 billion. Quarterly financial results are anticipated in early March.

European Commercialization Strategy Unveiled

The foundation for the expansion is the conditional marketing authorization granted by the European Commission on February 18, 2026, for ANKTIVA. The drug is approved for use in combination with BCG for the treatment of non-muscle invasive bladder cancer in patients who are no longer responsive to BCG alone. According to the company, roughly 157,000 individuals in the EU and UK are diagnosed with this form of cancer annually, with between 10% and 20% falling within the approved indication.

On February 19, ImmunityBio disclosed a partnership with Accord Healthcare to commercialize ANKTIVA across 30 European countries. Accord will deploy a dedicated team of 85 personnel for the product's marketing. To oversee its European operations, ImmunityBio has established a subsidiary in Dublin.

With this latest authorization, ANKTIVA is now approved in four major markets: the United States (April 2024), the United Kingdom (July 2025), Saudi Arabia (January 2026), and the European Union (February 2026), covering a total of 33 countries.

Expansion Across the Middle East

The following day, February 20, brought news of a second agreement. ImmunityBio has entered into collaborations with Biopharma and Cigalah Healthcare for the distribution of ANKTIVA in Saudi Arabia and the broader MENA (Middle East and North Africa) region. The therapy is expected to be available in the region within 60 days. Saudi Arabia's drug regulatory authority has already issued a registration certificate with a set price.

Furthermore, ImmunityBio has formed a wholly-owned subsidiary in Saudi Arabia. The company is reportedly in discussions with health authorities in Saudi Arabia and the United Arab Emirates to pursue regulatory approvals for ANKTIVA in additional cancer indications beyond lung and bladder cancer.

Regulatory Updates and Clinical Trial Progress

Concurrent with the EU announcement, ImmunityBio provided an update on its U.S. regulatory activities. The U.S. Food and Drug Administration (FDA) had requested supplementary data related to papillary bladder cancer, which the company has submitted and is now awaiting review. Separately, a randomized study involving BCG-naïve patients is nearing the completion of its recruitment phase.

Legal Investigation Announced

A potential concern for investors emerged on February 20, when the law firm Pomerantz LLP announced it was investigating claims on behalf of ImmunityBio shareholders. While no specific details were provided, such investigations can potentially impact corporate reputation and carry legal ramifications.