ImmunityBio Shares Surge on European Regulatory Milestone

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ImmunityBio's stock experienced a dramatic upward move following a pivotal regulatory decision from Europe. The company's flagship cancer therapy, Anktiva, has received conditional marketing authorization from the European Commission, a development that immediately fueled a powerful rally in the company's share price on Wednesday. This approval marks a significant expansion of the drug's commercial reach, raising questions about the long-term sustainability of the market's enthusiastic reaction.

The European Commission granted conditional approval for Anktiva as a treatment for bladder cancer. This authorization provides access to the therapy for patients across 30 countries, including all 27 member states of the European Union. Anktiva represents the first immunotherapy option in Europe for this specific form of the disease. Previously, patients who did not respond to standard treatments faced surgery as a primary alternative.

This regulatory green light follows a positive recommendation issued by the European Medicines Agency in December 2025. The decision substantially enlarges ImmunityBio's addressable market, considering that over 150,000 patients in Europe receive a bladder cancer diagnosis each year.

Market Mechanics Amplify the Rally

The response on the trading floor was immediate and forceful. On Wednesday, ImmunityBio shares climbed 41.9 percent to reach $8.54. Trading volume skyrocketed to nearly 80 million shares, representing an 87 percent increase compared to the average.

A notable factor intensifying the price movement was the market's positioning ahead of the news. Short interest had recently hit a record level, amounting to 13.7 percent of the freely tradable shares. The sudden price surge placed significant pressure on these bearish positions, likely accelerating the upward trend as traders moved to cover their shorts. Heightened activity was also visible in the options market, with more than 30,000 call options traded on the day of the approval.

Clinical Trial Results Underpin Regulatory Confidence

The authorization is founded on robust data from the QUILT-3.032 clinical study. Results demonstrated a complete response rate of 71 percent, with a median duration of response exceeding two years. A critical benefit for patient quality of life is organ preservation: more than 80 percent of trial participants were able to retain their bladder over a three-year period, thereby avoiding a radical cystectomy.

Global Commercial Footprint Expands Rapidly

With its entry into the European market, Anktiva is now approved in four major regulatory regions. The therapy had previously received authorization in the United States, the United Kingdom, and Saudi Arabia. ImmunityBio has established this global presence in less than two years since its initial approval from the U.S. Food and Drug Administration.

This rapid commercial rollout is already reflected in the company's financial performance. According to Nasdaq data, Anktiva sales grew by over 700 percent during the 2025 fiscal year.

The conditional nature of the EU approval requires ImmunityBio to continue submitting long-term data on the drug's safety and efficacy, with the authorization subject to annual renewal. Nevertheless, a successful European launch constitutes a major milestone for the company, significantly broadening its commercial foundation and reducing its previous reliance on the U.S. market.