ImmunityBio’s stock experienced a dramatic single-day rally, closing 41.9% higher on Wednesday and reaching a new 52-week peak. This surge was fueled by a pivotal regulatory decision from European authorities concerning the company’s cancer therapy.
European Approval Opens Major Market
The European Commission granted a conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) on February 18, 2026. The therapy, used in combination with Bacillus Calmette-Guérin (BCG), is now approved for treating adult patients with BCG-resistant non-muscle invasive bladder cancer. Eligible patients include those with carcinoma in situ, with or without accompanying papillary tumors.
This decision followed a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use on December 11, 2025. With this authorization, ANKTIVA plus BCG becomes the first immunotherapy approved in Europe for this specific bladder cancer indication, providing a new treatment avenue where few existed.
Trading Activity Reflects Market Sentiment
Equity trading was exceptionally active. ImmunityBio shares climbed as high as $8.68 during the session before settling at a close of $8.54. Trading volume was a standout feature, reaching approximately 79.2 million shares—a figure roughly 87% above the average.
The news appeared to catch some market participants off guard. Data indicated short interest had risen to 13.7% of the float in the days leading up to the announcement. Options markets saw explosive activity, with over 30,000 call contracts traded on February 18 alone, resulting in a put-call ratio near 0.09.
Foundation in Clinical Trial Results
The conditional authorization rests on data from the QUILT-3.032 clinical trial, an open-label, single-arm, multi-center Phase 2/3 study. Key efficacy metrics from the trial include:
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- Complete Response Rate: 71%
- Median Duration of Response: 26.6 months
- Cystectomy-Free Survival in Responders: 84% at 36 months
- Disease-Specific Survival: 99% at 36 months
This addresses a significant unmet need in Europe, where over 150,000 patients are diagnosed with non-muscle invasive bladder cancer annually. Until now, radical cystectomy—the complete removal of the bladder—has often been the only option following BCG treatment failure.
Global Regulatory Footprint Expands
The EU decision significantly broadens the therapy’s global availability. ANKTIVA is now approved in four major regulatory jurisdictions:
- United States: Received FDA approval in April 2024.
- United Kingdom: Secured MHRA approval in July 2025.
- Saudi Arabia: Granted an accelerated SFDA approval in January 2026.
- European Union: Conditionally authorized in February 2026, covering all 27 member states plus Iceland, Liechtenstein, and Norway.
This brings the total number of countries with access to the treatment to 33, less than two years after its initial U.S. approval.
Path Forward and Conditions
A conditional marketing authorization in the EU facilitates earlier patient access for therapies addressing serious unmet medical needs. It is subject to annual renewal, and ImmunityBio is required to submit ongoing long-term data from clinical studies to further confirm the treatment’s benefit-risk profile.
The company’s immediate focus will now shift to negotiating pricing and reimbursement agreements with individual EU member states, a critical step to ensure patients can practically obtain the new therapy.
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