What's Driving ImmunityBio's Recent Surge

Key Takeaways

• ImmunityBio (IBRX) has seen its shares surge by 29.90% following conditional EU marketing authorization for its bladder cancer therapy, ANKTIVA, expanding its global footprint to 33 countries.
• ANKTIVA's commercial momentum is robust, with preliminary $113 million in 2025 net product revenue, representing a 700% year-over-year increase, driven by strong adoption and a unique mechanism of action.
• While international expansion offers significant revenue potential, successful commercialization hinges on navigating complex pricing, reimbursement, and supply chain challenges across diverse healthcare systems.

What's Driving ImmunityBio's Recent Surge?

ImmunityBio (NASDAQ: IBRX) has captured the market's attention, with shares climbing by an impressive 29.90% to $7.82 as of February 18, 2026. This significant jump pushes the stock closer to its 52-week high of $8.28, a stark contrast to its $1.83 low. The catalyst for this renewed investor enthusiasm is clear: the European Commission's recent conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.

This latest approval, announced on February 18, 2026, is a game-changer, expanding ANKTIVA's reach across 33 countries within the EU. It builds on a rapid succession of regulatory wins, including FDA approval in the U.S. in April 2024, authorization in the U.K. in July 2025, and Saudi FDA approval in January 2026. This swift global expansion, achieved in under two years, transforms ImmunityBio from a clinical-stage biotech into a rapidly growing commercial entity with a substantial international footprint.

The market is reacting to more than just regulatory milestones. ImmunityBio reported preliminary net product revenue of approximately $113 million for the full year 2025, marking an astounding 700% increase year-over-year. The fourth quarter of 2025 alone saw $38.3 million in revenue, a 20% quarter-over-quarter increase and a 431% surge from the prior year. This robust sales momentum, coupled with the upcoming 2026 ASCO Genitourinary Cancers Symposium where ANKTIVA will be spotlighted, paints a picture of a company hitting its stride commercially. Investors are clearly betting on this momentum to continue, as evidenced by the company's current market capitalization of $7.70 billion.

ANKTIVA's Commercial Trajectory: Is ImmunityBio's Bladder Cancer Therapy a Blockbuster in the Making?

ANKTIVA's impressive sales trajectory suggests it's rapidly gaining traction in a critical unmet medical need. The preliminary $113 million in 2025 net product revenue, a 700% year-over-year increase, is a testament to its market adoption. This growth isn't just about revenue; it's backed by a 750% unit sales volume growth in 2025 compared to 2024, indicating strong demand for the therapy. The introduction of a permanent J-code (J9028) by the Centers for Medicare & Medicaid Services on January 1, 2025, was a significant catalyst, streamlining reimbursement and accelerating sales.

What sets ANKTIVA apart is its unique mechanism of action. Designated an FDA Breakthrough Therapy, it's the first FDA-approved immunotherapy for NMIBC carcinoma in situ (CIS) that activates natural killer (NK) cells, T cells, and memory T cells, aiming for a long-duration response. Clinical data from the QUILT-3.032 trial showed a 71% complete response rate (CRR) in BCG-unresponsive NMIBC CIS patients, with a median duration of response (DoR) exceeding 21 months, now reported at 54 months of ongoing duration. This prolonged response is a critical differentiator in a disease where the primary alternative for BCG-unresponsive patients has often been radical cystectomy, a highly invasive procedure.

The market opportunity for ANKTIVA is substantial, particularly in the high-risk BCG-unresponsive NMIBC segment. The global scarcity of BCG has further exacerbated challenges for patients, limiting adequate induction and maintenance therapies and leading to higher recurrence rates. ANKTIVA offers a much-needed alternative in this context. Analysts are bullish, with a consensus "Buy" rating from all five covering analysts and a forward revenue estimate of $1.1 billion for FY 2028 and $1.9 billion for FY 2029, signaling confidence in its blockbuster potential. This optimism is reflected in the company's high price-to-sales (P/S) ratio of 93.39, indicating that significant future growth is already priced into the stock.

Navigating the Global Market: What are the Opportunities and Hurdles for International Expansion?

The recent conditional marketing authorization for ANKTIVA in the EU, alongside approvals in the U.K. and Saudi Arabia, represents a massive opportunity for ImmunityBio. Europe alone sees over 150,000 patients diagnosed annually with NMIBC, presenting a significant addressable market for ANKTIVA, especially given the lack of authorized therapies for BCG-unresponsive patients. This global regulatory footprint, now spanning 33 countries, positions ImmunityBio for substantial revenue growth beyond its U.S. base.

However, international commercialization is not without its complexities. The EU authorization is conditional, requiring ImmunityBio to submit long-term safety and efficacy data to the European Medicines Agency (EMA) for annual renewal. This ongoing commitment means sustained performance and timely data submissions are critical to maintaining approval. More importantly, the company faces the intricate task of obtaining pricing and reimbursement approvals across individual EU member states. Each country has its own unique healthcare system, pricing negotiations, and reimbursement policies, which can lead to delays in market uptake and vary the commercial realization of the approval.

Furthermore, manufacturing, supply chain, and distribution logistics will be crucial. ImmunityBio must coordinate with multiple European BCG strains used in combination with ANKTIVA, adding another layer of complexity. The company's vertically integrated model, which includes controlling every element of the supply chain, including BCG and diluent, should mitigate some of these risks. In the U.S., the ImmunityBio CARE™ program and coverage by commercial and government insurance programs, including the VA, DoD, and Medicare, demonstrate a robust market access strategy. Replicating this success across diverse international markets will be a key determinant of ANKTIVA's global commercial impact.

Beyond Bladder Cancer: What's Next for ImmunityBio's Pipeline and Platform?

While ANKTIVA's success in bladder cancer is a primary driver, ImmunityBio is far from a single-product company. The company is actively developing a broader "Cancer BioShield" platform, aiming to leverage its immunotherapy and cell therapy technologies across multiple cancer types and infectious diseases. This strategy seeks to bolster the natural immune system, driving durable and safe protection against disease, potentially reducing or eliminating the need for high-dose chemotherapy.

A significant area of ongoing development is lymphopenia. ImmunityBio has already submitted an Expanded Access Program (EAP) to the FDA to make ANKTIVA available for lymphopenia, a condition characterized by the loss of natural killer cells and T cells crucial for fighting cancer. The company has completed multiple trials in healthy volunteers and various cancer types, including first-line and third-line lung cancer, metastatic pancreatic cancer, and other tumor-agnostic basket trials involving 147 patients. These trials have shown ANKTIVA's ability to stimulate and maintain absolute lymphocyte count (ALC), demonstrating its potential beyond bladder cancer. The data from these trials is being compiled for a Biologics License Application (BLA) filing, with a physical meeting with the FDA scheduled for May 2026.

ImmunityBio's CEO, Richard Adcock, emphasizes that the company is "not a urology-only company, we're not an ANKTIVA-only company." The core of their strategy involves manipulating immune cells, including CAR-NK cells and memory-like NK cells, at scale. The company believes ANKTIVA acts as a "magic glue" when added to cell therapy, enhancing its efficacy in ways other therapies cannot. This broad platform approach, coupled with vertical integration to control manufacturing, positions ImmunityBio to potentially address a wide range of oncology indications, transforming it into a diversified immunotherapy player rather than just a bladder cancer specialist.

Is ImmunityBio a Buy, Hold, or Sell?

ImmunityBio's recent performance and regulatory wins paint a compelling picture, but a balanced view is essential for investors. The company's stock has surged, with a 106.94% one-year total shareholder return, reflecting strong investor confidence. Wall Street analysts are unanimously bullish, with all five covering analysts rating IBRX a "Buy" and a consensus price target of $7.00. This target, however, is slightly below the current trading price of $7.82, suggesting some analysts may need to update their models to reflect the latest EU approval and sales momentum.

From a valuation perspective, ImmunityBio is still a growth story. The company remains loss-making, reporting a net loss of $348.6 million and negative equity. Its P/S ratio of 93.39 is exceptionally high, indicating that the market is heavily pricing in future growth. However, analysts project substantial forward revenue growth of 51.9% per year and earnings growth of 62.7% per year, with an estimated EPS of $0.35 for FY 2028 and $0.95 for FY 2029. A discounted cash flow (DCF) model by Simply Wall St suggests a fair value of $20.22, implying the stock could still be undervalued despite its recent run.

The key risks include the company's reliance on ANKTIVA's continued commercial success and clinical progress across its broader pipeline. While cash, cash equivalents, and marketable securities stood at an estimated $242.8 million as of December 31, 2025, the high operating expenses inherent in biotech development mean continued capital management will be crucial. The execution risk on pricing, reimbursement, and market access in new international territories also remains a significant hurdle. For investors with a high-risk tolerance and a long-term view, ImmunityBio presents an intriguing opportunity, but it requires careful monitoring of commercial execution and pipeline advancements.

ImmunityBio stands at a pivotal juncture, transitioning from a clinical-stage biotech to a commercial growth story with a global footprint. ANKTIVA's strong sales momentum and expanding international approvals are undeniable tailwinds, offering significant revenue potential in the NMIBC market. However, investors must weigh the substantial growth prospects against the inherent risks of commercialization in complex global markets and the need for continued pipeline success.

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