European Approval Fuels Momentum for ImmunityBio Shares

ImmunityBio gains conditional EU marketing authorization for ANKTIVA, triggering a 42% stock surge and a strategic partnership with Accord Healthcare for European rollout.

ImmunityBio has achieved a pivotal regulatory milestone in Europe, providing a significant boost to its stock this week. The European Commission granted a conditional marketing authorization for ANKTIVA, substantially expanding the therapy's commercial potential. The key question now is how swiftly the company can translate this approval into revenue across European markets.

Stock Surge and Trading Activity

The market responded enthusiastically to the news. On Tuesday, shares of ImmunityBio closed at $8.54, marking a substantial single-day gain of approximately 42%. Investor interest was notably high, with trading volume reaching 78.5 million shares. This figure was roughly 178% above the three-month average daily volume of 28.2 million shares, indicating a surge in market participation.

Details of the Conditional EU Authorization

The European Commission's approval covers the use of ANKTIVA (nogapendekin alfa inbakicept) in combination with BCG for treating a specific form of bladder cancer. The indication is for patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. This authorization follows earlier approvals in the United States, the United Kingdom, and Saudi Arabia, opening access to another major healthcare market.

Commercial Strategy for the European Launch

To accelerate its European rollout, ImmunityBio announced two strategic moves concurrently with the regulatory decision. The company has entered into a distribution partnership with Accord Healthcare and established an Irish subsidiary to support commercialization efforts across the region.

According to the company's statement, Accord Healthcare plans to deploy more than 100 specialized personnel in sales, medical affairs, and marketing. This network will support the launch in the UK, the EU, and EFTA nations, including Iceland, Liechtenstein, and Norway. The partnership agreement encompasses approximately 30 countries. ImmunityBio estimates the addressable market size at about 157,000 annual NMIBC diagnoses combined across the EU and UK.

Market Reaction and Broader Regulatory Context

Following the sharp rally, some profit-taking was observed on Thursday. Reports indicated the stock opened at $8.05, down from the previous close of $8.54, and traded as low as $7.64 during the session.

Beyond Europe, the company provided updates on its regulatory landscape in the United States. ImmunityBio stated it has submitted a response to an FDA request for additional data concerning the indication for BCG-unresponsive papillary NMIBC (without CIS). Furthermore, a randomized study involving BCG-naïve patients is nearing full recruitment.

Additional Investor Considerations

The report referenced other factors for investors to monitor. These include an announced investor class action review by the law firm Pomerantz and recent insider selling activity. Based on SEC filings cited in the report, insiders sold 226,967 shares worth approximately $1.53 million in the last quarter.

On the analyst front, the consensus rating was noted as "Moderate Buy," with an average price target of $11.80.

Year-to-Date Performance and Growth Drivers

ImmunityBio's stock has demonstrated remarkable strength in 2024, with its value more than quadrupling year-to-date according to the report. This performance is underpinned by several factors: robust commercial growth for ANKTIVA, which reportedly saw revenue surge over 700% in 2025, further international approvals, and promising clinical data in additional cancer indications. These include ongoing studies in non-small cell lung cancer.