ImmunityBio (IBRX) shares surged more than 40% on Wednesday after the biopharmaceutical company secured a key regulatory approval in Europe for its lead immunotherapy, Anktiva.
The company announced that the European Commission has granted conditional marketing authorization for Anktiva in combination with the Bacillus Calmette-Guérin (BCG) vaccine for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. The approval opens the door for Anktiva in 30 member countries across the European Union, significantly expanding the drug’s commercial reach.
The stock closed at $8.54, up 41.86% on volume of 78.5 million shares—roughly 178% above its three-month average. The rally marks a dramatic rebound for a stock that has been under pressure since its IPO.
Wednesday’s approval is not Anktiva’s first. The immunotherapy received U.S. Food and Drug Administration clearance in 2024 for certain bladder cancer indications, followed by approvals in the United Kingdom in mid-2025 and Saudi Arabia in January 2026.
These regulatory wins have propelled ImmunityBio shares to more than quadruple in 2026. According to the company, Anktiva sales surged over 700% in 2025, and revenue for the fiscal year ending December 2025 is projected at $113 million, with fourth-quarter sequential growth of 20% alone. For a drug that has been on the market for less than two years in the U.S. and only months in the U.K., the uptake has been robust.
Beyond bladder cancer, ImmunityBio is investigating Anktiva in a range of other indications, including non-small cell lung cancer, solid tumors, Lynch syndrome, HIV, ovarian cancer, and non-Hodgkin lymphoma.
Despite the euphoria, ImmunityBio’s history serves as a reminder of its volatile nature. The stock has fallen 75% since its 2015 IPO, and even after this year’s rally, its market capitalization remains under $8 billion. The company is still heavily reliant on Anktiva’s clinical and commercial progress, making its shares highly sensitive to news flow around the drug.
Wednesday’s sharp gain could prompt short-term profit-taking, analysts caution. For investors willing to stomach the risk, the global oncology market is projected to expand from less than $350 billion last year to $860 billion by 2034, offering substantial runway for Anktiva if it continues to gain approvals and expand its label.
As ImmunityBio adds Europe to its growing list of markets, the story for Anktiva is just beginning—but so is the volatility that comes with it.
