European Approval Ignites Surge for ImmunityBio Shares

ImmunityBio's stock surged over 40% after EU approval for its bladder cancer drug ANKTIVA, securing a major distribution deal and expanding its European operations.

ImmunityBio's stock value soared by more than 40% in a single trading session this week. This dramatic surge was triggered by a pivotal regulatory milestone: the European Commission granted a conditional marketing authorization for the company's immunotherapy, ANKTIVA. Concurrently, the biotech firm secured a major distribution partner and is actively expanding its operational footprint across the continent.

The authorization paves the way for ANKTIVA's use across all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. This brings the total number of countries where the therapy is approved to 33. ANKTIVA (nogapendekin alfa inbakicept) is indicated in combination with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.

For this high-risk patient group, radical cystectomy has historically been the primary alternative. ANKTIVA now stands as the first immunotherapy approved in Europe for this specific indication.

Clinical Performance and Addressable Market

The approval is underpinned by clinical trial data demonstrating that the combination of ANKTIVA and BCG achieved a complete response rate of 71%, with durable responses observed.

According to company estimates, approximately 157,000 individuals in the EU and UK are diagnosed with NMIBC each year. It is projected that between 10% and 20% of these cases involve carcinoma in situ.

Commercial Strategy Takes Shape

On February 19, 2026, ImmunityBio announced a comprehensive distribution partnership with Accord Healthcare. To commercialize ANKTIVA in the UK, EU, and EFTA member states, Accord Healthcare plans to deploy a dedicated team of over 100 professionals specializing in sales, medical affairs, and marketing.

In a parallel strategic move, ImmunityBio has established an Irish subsidiary headquartered in Dublin. This entity is designed to function as the operational hub for the company's European sales and commercialization activities.

A Series of Global Regulatory Wins

The European decision marks the fourth major market authorization for ANKTIVA in combination with BCG for NMIBC within a two-year span, building significant commercial momentum:

• United States: Received FDA approval in April 2024.
• United Kingdom: Secured MHRA approval in July 2025.
• Saudi Arabia: Obtained SFDA approval in January 2026.
• European Union: Granted conditional authorization in February 2026.

Beyond these approvals, ImmunityBio is pursuing a label expansion in the U.S. The company has submitted additional data to the FDA concerning BCG-unresponsive papillary NMIBC. Furthermore, a randomized study involving BCG-naïve patients is nearing the completion of its recruitment phase.

Short Squeeze Amplifies Rally

Market data from Stocktwits indicated that short interest in ImmunityBio's stock reached a record 13.7% of the free float in the period from February 13 to 19. The announcement of the EU approval catalyzed substantial trading volume, contributing to the powerful upward move in the share price on February 19.

Path Forward in Europe

While the conditional authorization unlocks a significant new market for ImmunityBio, key steps remain before a full commercial launch. The company must now navigate pricing discussions and secure reimbursement agreements with individual national health authorities across the EU. The established partnership with Accord Healthcare provides the necessary commercial infrastructure, and the Dublin base will support timely market entry efforts.