ImmunityBio Shares Surge on Strong Commercial Performance and Regulatory Wins

ImmunityBio's ANKTIVA drives 700% revenue surge in 2025, gains EU approval, and sparks a major 2026 stock rally, though profitability challenges remain.

ImmunityBio's stock has been on a remarkable upward trajectory, fueled by the company's first substantial commercial figures and significant international regulatory progress. The biotech firm's immunotherapy, ANKTIVA, is driving this momentum, though questions about its path to sustained profitability remain.

Financial Performance Shows Explosive Growth

The company reported net product revenue for ANKTIVA reaching approximately $113 million in 2025. This staggering figure represents a surge of roughly 700% compared to its 2024 results. The fourth quarter alone contributed about $38.3 million in revenue, marking a sequential increase of 20% and a year-over-year jump of 431%.

On the bottom line, the loss per share for Q4 stood at $0.06, outperforming analyst expectations of a $0.09 loss. Despite this positive earnings surprise, profitability remains a central challenge. ImmunityBio posted a net loss of about $351 million for the full year 2025. The company invested heavily in research, with Q4 R&D expenditures alone totaling around $64 million. Management highlighted a positive trend, noting three consecutive quarters of declining losses.

International Expansion Gains Momentum

Recent weeks have brought a series of regulatory and commercial victories outside the United States. The European Commission granted conditional marketing authorization for ANKTIVA plus BCG to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. This approval is valid across all 27 EU member states, as well as Iceland, Norway, and Liechtenstein.

Shortly after, ImmunityBio announced a distribution partnership with Accord Healthcare. This agreement will leverage Accord's 85-person sales team to expand patient access across 30 European countries. Furthermore, the company established a partnership for Saudi Arabia and the MENA region (via Biopharma and Cigalah Healthcare) to address bladder and lung cancer patients. To support its European operations, an Irish subsidiary has been opened.

According to the company, ANKTIVA is now approved in 33 countries across four regulatory jurisdictions, an achievement secured in less than two years since its initial FDA approval in April 2024. Notably, the Saudi approval includes a conditional authorization for metastatic non-small cell lung cancer, representing the therapy's first clearance outside its original bladder cancer indication.

Stock Rally and Insider Trading Activity

ImmunityBio's share price has experienced a powerful rally in 2026. Starting the year around the $2 level, the equity climbed to a new 52-week intraday high of $12.28. In a recent Monday session, the stock gained 17.5% to close at $11.55. Trading volume has been exceptionally heavy, exceeding 82 million shares on that day and over 85 million the session prior—more than double the three-month average. The company's market capitalization was reported at approximately $11.38 billion.

Amid this share price strength, regulatory filings revealed insider selling. Director Barry J. Simon sold a total of 175,000 shares on February 20 and 23, generating proceeds of about $1.78 million at prices between $9.25 and $10.25 per share. The sales were executed under a pre-arranged Rule 10b5-1 trading plan adopted in September 2024. Following these transactions, Simon retains direct ownership of roughly 2.93 million shares.

A separate notice mentioned an "Investor Alert" issued by the Pomerantz Law Firm regarding an investigation into potential claims by ImmunityBio investors, though available sources did not provide specific details.

Pipeline and Regulatory Milestones Ahead

Looking forward, ImmunityBio outlined several near-term priorities beyond commercialization. This includes the resubmission of its application for papillary bladder cancer. After receiving a "refuse-to-file" letter from the FDA in 2025, the agency requested additional information but did not mandate new clinical studies. The company stated it submitted this documentation within a 30-day window in January.

Additionally, a clinical study in BCG-naïve patients is underway, with recruitment reported to be over 85% complete. The goal is to submit a Biologics License Application (BLA) by the fourth quarter of 2026. The company is also in discussions with the FDA regarding lung cancer indications in the U.S. During a February 23 event, Chairman Patrick Soon-Shiong reportedly outlined a three-year expansion roadmap for the therapy.