Why Is ImmunityBio (IBRX) Rallying Today? EU Approves Anktiva

Shares of ImmunityBio, Inc. (NASDAQ: IBRX) are surging Wednesday after the company announced a major regulatory milestone: the European Commission has granted conditional marketing authorization for its immunotherapy Anktiva (nogapendekin alfa inbakicept) in combination with BCG for the treatment of adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.

The approval, which covers all 27 EU member states plus Iceland, Norway, and Liechtenstein, marks the first authorized treatment in Europe for this specific bladder cancer condition, an area where patients previously faced radical cystectomy as their only alternative.

With this authorization, Anktiva is now approved across 33 countries spanning four regulatory jurisdictions, a global footprint built in under two years from its initial FDA approval in April 2024.

EU Approval: What It Means and Why It Matters

The European Commission’s decision, dated February 16, 2026, was based on results from the QUILT-3.032 study — a single-arm, open-label Phase 2/3 trial in 100 adults with BCG-unresponsive NMIBC CIS. The trial demonstrated a 71% complete response rate, a median duration of complete response of 26.6 months, and individual responses lasting up to 54 months and beyond.

Notably, more than 80% of treated patients preserved their bladder through three years of follow-up, a meaningful outcome given that the previous standard of care for non-responders was bladder removal surgery.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion in December 2025, concluding that the benefits of early patient access outweighed the risks associated with the single-arm trial design, paving the way for Wednesday’s formal authorization.

The scale of the unmet need in Europe underscores the commercial significance of this approval. Bladder cancer is the fifth most common cancer in the EU, with more than 200,000 new cases expected in 2025 alone, approximately 75% of which are NMIBC.

Prior to Anktiva’s authorization, there were no approved therapies in the EU for patients whose disease failed BCG therapy. ImmunityBio CEO Richard Adcock emphasized that the company is now focused on navigating individual EU member state pricing and reimbursement processes to ensure patient access.

The company also noted a supply advantage: unlike the US, which approves only one BCG strain, Europe has approved approximately six, providing a more reliable supply base for the Anktiva-BCG combination regimen. As a conditional authorization, ImmunityBio will be required to submit ongoing long-term safety and efficacy data to the EMA annually.

Join our Telegram group and never miss a breaking digital asset story.

IBRX Stock Brief: Price Action and Key Metrics

As of mid-morning trading on February 18, 2026, IBRX shares were trading at approximately $7.38, up $1.36 or roughly 22.6% on the day, after opening at $6.06 against a previous close of $6.02. The stock hit an intraday high of $7.21 early in the session before extending gains, with volume reaching over 12 million shares, well below its average daily volume of approximately 27.6 million, suggesting the move may have more room to run as the session progresses.

The market capitalization surged to approximately $7.09 billion intraday, up from around $5.86 billion as recently as February 13. The 52-week range of $1.83 to $8.28 illustrates just how dramatic IBRX’s run has been. The stock has returned over 263% year-to-date and more than 114% over the trailing one-year period, vastly outpacing the S&P 500’s roughly 0.7% YTD gain.

Analyst sentiment on IBRX remains constructive, with the most recent rating from D. Boral Capital maintaining a Buy with a $24 price target as of February 17, 2026 — well above current trading levels. The average analyst price target stands at $11.80, still implying meaningful upside from today’s prices.

That said, the company’s financial picture warrants caution: ImmunityBio reported trailing twelve-month revenue of $82.56 million against a net loss of $348.62 million, with an operating margin deeply negative at around -316% and a distress-level Altman Z-Score flagged by analysts.

The company holds $257.81 million in cash, providing near-term runway, and its gross margin of approximately 99.5% reflects strong product-level economics. The challenge remains scaling revenue fast enough to offset heavy operating expenses. With earnings expected March 2, 2026, investors will be watching closely for any updated commercial guidance in the wake of the EU approval.

Disclaimer: The author does not hold or have a position in any securities discussed in the article. All stock prices were quoted at the time of writing.