ImmunityBio Shares Surge 42% After EU Grants Conditional Approval for Anktiva Bladder Cancer Therapy

ImmunityBio announced in February 2026 that the European Commission granted conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary tumors. The approval covers all 27 EU countries, plus Iceland, Norway, and Liechtenstein, putting the drug in 33 markets. ImmunityBio's stock closed Wednesday at $8.54, up 41.86%.

This decision makes Anktiva plus BCG the first immunotherapy option authorized in Europe for these high-risk patients, whose main alternative had been radical cystectomy. The approval is underpinned by phase 2/3 data showing durable complete responses and a favorable safety profile.

Trading volume reached 78.5 million shares, about 178% above its three-month average of 28.2 million shares. The stock slipped roughly 0.5% to $8.50 before the bell the following day.

Conditional approvals in the EU push drugs out faster in cases of unmet need, but companies face extra requirements. These approvals run for just a year at first, then must be renewed yearly as firms supply follow-up data that regulators demand after the green light. As part of this conditional approval, ImmunityBio is obligated to continue monitoring clinical trial participants and provide the European Medicines Agency with extended safety and efficacy data over the long term from the company's Phase 2/3 QUILT-3.032 study. The European Medicines Agency had previously endorsed the treatment in December.

ImmunityBio grabbed U.S. FDA clearance back in April 2024 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, the flat high-risk type found in the bladder lining. That nod followed an earlier FDA rejection over manufacturing problems.

On Tuesday, the company said Saudi regulators had urged it to submit a package for its recombinant BCG within the next few weeks, as it hunts for new supply routes during ongoing shortages. The company also highlighted ongoing talks about using Anktiva with checkpoint inhibitors in more cancer types.

ImmunityBio's stock has now more than quadrupled in 2026 as the company grew Anktiva sales over 700% in 2025, also received approvals from the Saudi Food and Drug Authority, released promising data on Anktiva treating non-small cell lung cancer, and highlighted a growing number of use cases for Anktiva, such as treating solid tumors.

The field's packed and in flux. Merck landed FDA clearance for Keytruda back in 2020, specifically targeting certain high-risk non-muscle invasive bladder cancer patients who can't or won't have their bladders removed, and who don't respond to BCG. Pfizer has advanced its own bladder cancer effort, touting late-stage trial results it claims hit the primary endpoint.

ImmunityBio is an integrated clinical-stage biotechnology company focused on discovering, developing, and commercializing next-generation immuno- and cellular therapies. These therapies aim to bolster the natural immune system to drive and sustain an immune response. The company's platforms include antibody-cytokine fusion proteins, DNA, RNA, and recombinant protein vaccines, and cell therapies, with a focus on bladder, lung, and colorectal cancers, as well as glioblastoma multiforme. Anktiva is an IL-15 superagonist antibody-cytokine fusion protein. The company operates primarily in the United States and Europe, with key revenue generated from the U.S.

ImmunityBio's market capitalization stands at approximately $5.86 billion to $7.48 billion. The company IPO'd in 2015 and has fallen 75% since going public. Revenue stands at $82.56 million, with a 3-year growth rate of 119%. The current ratio of 5.77 and quick ratio of 5.65 suggest strong liquidity, but the debt-to-equity ratio of -1.03 indicates financial distress. The Altman Z-Score of -7.24 places the company in the distress zone. Insider activity shows two insider selling transactions in the past three months, with no insider buying, totaling 226,967 shares sold.

Traders are keyed in on any hints around launch timing in Europe and whatever ImmunityBio has to say about demand trends. The ASCO Genitourinary Cancers Symposium kicks off in San Francisco Feb. 26–28. ImmunityBio is slated to deliver results in early March, with market calendars flagging March 2 as the date to watch for the next earnings release.