ImmunityBio Stock Soars 295% YTD: Time to Buy, Hold or Sell?

Shares of ImmunityBio IBRX have skyrocketed nearly 300% year to date, significantly outperforming the industry’s 6% growth. The stock has outperformed the sector and the S&P 500 during the same period, as shown in the chart below.

IBRX Stock Outperforms Industry, Sector & S&P 500

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This upside is attributable to the encouraging financial performance of Anktiva, the company’s sole marketed product. The drug is currently approved by the FDA in combination with Bacillus Calmette-Guérin (BCG) for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

Let’s explore the company’s fundamentals to better understand how to play the stock amid the recent rally.

Anktiva — The Key Driver of IBRX’s Top-line Growth

The launch trajectory of Anktiva has been impressive since its approval in 2024. Last month, ImmunityBio reported encouraging fourth-quarter and full-year 2025 results, pointing to a strong finish. The company reported net product revenues of $113 million for the full year 2025, up about 700% year over year. Per the company, repeat prescribing has been a major driver of sales growth, suggesting growing confidence among physicians in the drug’s efficacy and safety profile.

Another factor supporting demand is the ongoing BCG shortage, which has created treatment bottlenecks in bladder cancer care. Since Anktiva is used in combination with BCG, physicians appear increasingly willing to prioritize high-value treatment regimens for eligible patients.

ImmunityBio is pursuing additional label expansion opportunities for Anktiva. It recently resubmitted a supplemental regulatory filing with the FDA seeking label expansion for the combination of Anktiva and BCG in BCG-unresponsive NMIBC with papillary disease. The resubmission follows multiple discussions with the FDA and includes additional information requested by the agency after reviewing updated clinical data. This development indicates that the regulatory review process remains active and could further expand the eligible patient population for Anktiva if approved.

Beyond the United States, ImmunityBio is expanding Anktiva’s global regulatory footprint. Since the beginning of 2026, the therapy has secured approvals for the BCG-unresponsive NMIBC indication in both the European Union and Saudi Arabia, marking important international regulatory milestones. These approvals are expected to support ImmunityBio’s efforts to commercialize Anktiva outside the United States and could serve as meaningful catalysts for revenue growth as the company begins building partnerships and distribution networks in these regions.

Importantly, ImmunityBio is beginning to expand Anktiva beyond bladder cancer. In January, the therapy received its first regulatory approval in the non-small cell lung cancer (NSCLC) indication in Saudi Arabia. This milestone expands Anktiva’s presence into one of the largest oncology markets and could significantly broaden the drug’s commercial opportunity if adoption gains traction in this setting. The company intends to hold discussions with the FDA later this year, seeking label expansion for the drug in a similar NSCLC indication.

IBRX’s Anktiva Label Expansion Studies Show Promise

Beyond its commercial portfolio, the company continues to advance its pipeline programs aimed at expanding the therapeutic potential of Anktiva across multiple oncology indications.

ImmunityBio is currently evaluating the drug in several clinical studies across solid tumors and hematologic malignancies as part of its broader Cancer BioShield platform strategy. In this strategy, the therapy acts as a backbone immunotherapy designed to stimulate immune cells such as natural killer (NK) cells and T cells.

In bladder cancer, the company is advancing a randomized study evaluating Anktiva plus BCG in BCG-naïve NMIBC patients, with a potential FDA filing targeted later this year. Additional studies are evaluating the therapy across other settings of the disease, which could further broaden the addressable population within the NMIBC setting if successful.

The company is exploring Anktiva’s potential, in combination with standard of care or CAR-NK cell therapies, across several other difficult-to-treat cancers, including NSCLC, pancreatic cancer, glioblastoma, colorectal cancer and hepatocellular carcinoma.

A successful development across the above clinical studies could position Anktiva as a foundational immunotherapy platform for multiple cancer types, potentially supporting additional regulatory filings and long-term growth if clinical outcomes remain encouraging.

Competitive Pressure in Targeted Markets

Despite the promising growth trajectory, ImmunityBio operates in a highly competitive oncology landscape dominated by Big Pharma. Anktiva competes with well-established immunotherapies such as Merck’s MRK Keytruda, Bristol Myers’ BMY Opdivo and Roche’s RHHBY Tecentriq. These drugs are already widely used across several oncology indications, including those targeted by ImmunityBio.

Beyond having approved therapies, these large pharmaceutical companies possess significantly greater financial resources, extensive global commercial infrastructure and well-established supply chains. Their long-standing presence in oncology gives them deep clinical development experience and strong relationships with physicians and treatment centers, which could make market penetration more challenging for newer entrants like ImmunityBio.

Dependence on a Single Product: A Woe for IBRX

Another key risk is the company’s heavy reliance on a single commercial product. Currently, Anktiva remains ImmunityBio’s only marketed therapy and the primary driver of its revenue growth. Any slowdown in demand, regulatory setbacks related to label expansion or unexpected safety concerns could materially impact the company’s financial performance.

IBRX Stock Valuation & Estimates

The company is trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 32.59 times forward 12-month sales, above the industry average of 2.00 times.

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Estimate movements for ImmunityBio’s 2026 and 2027 EPS have been mixed during the past 30 days.

Image Source: Zacks Investment Research

How to Play IBRX Stock?

Despite the competitive pressure from large pharmaceutical companies, the early commercial performance of Anktiva suggests that the therapy is gaining meaningful traction in the market. Strong uptake following its launch and expanding regulatory approvals across multiple regions indicate that the drug could continue to drive revenue growth for ImmunityBio in the coming years.

Although the stock is trading above the industry average on the valuation front, we suggest investors hold on to this Zacks Rank #3 (Hold) company, given its growth potential. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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