ImmunityBio Criticizes FDA for Unequal Approval Standards
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 9 hours ago
0mins
Should l Buy IBRX?
Source: stocktwits
- FDA Approval Controversy: ImmunityBio's Executive Chairman Patrick Soon-Shiong criticized the FDA for imposing stricter approval standards on Anktiva, requiring randomized trials while allowing Keytruda to expand indications through single-arm trials, which limits Anktiva's approval to bladder cancer and affects patient treatment options.
- Urgent Patient Demand: Soon-Shiong highlighted that over 13,000 Americans are seeking access to Anktiva, but due to FDA restrictions, they can only receive the drug for specific types of bladder cancer, showcasing the regulatory bottleneck and its unreasonable nature.
- International Market Dynamics: Despite facing approval hurdles in the U.S., Anktiva has received a conditional marketing authorization recommendation from the European Medicines Agency and has been approved in Saudi Arabia, indicating potential for broader application in international markets.
- Clinical Research Progress: ImmunityBio recently launched a mid-stage study evaluating the efficacy of Anktiva combined with Rituximab in patients without the need for chemotherapy, aiming to further validate its potential in treating indolent B-cell non-Hodgkin lymphoma, which may pave the way for future FDA applications.
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Analyst Views on IBRX
Wall Street analysts forecast IBRX stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 5.945
Low
5.00
Averages
7.33
High
9.00
Current: 5.945
Low
5.00
Averages
7.33
High
9.00
About IBRX
Immunitybio, Inc. is a vertically integrated, clinical-stage biotechnology company developing therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. Using its applied science and platforms to treat cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies to reduce or eliminate the need for standard high-dose chemotherapy. Its platforms and their associated product candidates are designed to attack cancer and infectious pathogens by activating both the innate immune system, including NK cells, dendritic cells, and macrophages, as well as the adaptive immune system comprising B and T cells, in an orchestrated manner. Its platforms for the development of biologic product candidates include antibody-cytokine fusion proteins, vaccine vectors, and cell therapies. Its biologic commercial product candidate, Anktiva, is an IL-15 superagonist antibody-cytokine fusion protein.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- ANKTIVA Expansion Discussions: ImmunityBio has initiated discussions with the SFDA regarding the expansion of ANKTIVA in combination with checkpoint inhibitors to additional tumor types, building on the accelerated approval granted in January 2026 for metastatic non-small cell lung cancer, which enhances the company's competitive position in the market.
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- Regional Strategic Development: ImmunityBio plans to establish a regional office in Saudi Arabia to support physicians and patients across the Middle East and North Africa, reflecting the company's commitment to the market and accelerating the development and commercialization of innovative therapies through collaboration with the Saudi-USA Biotech Alliance.
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- Product Expansion: The company is exploring the use of Anktiva in combination with checkpoint inhibitors for various tumor types, supported by data from the QUILT-3.055 Phase 2b trial, which may enhance its market share by expanding indications in the relapsed patient population.
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- Regulatory Submission Encouragement: The SFDA has encouraged ImmunityBio to submit a regulatory package for recombinant BCG to address the ongoing BCG shortage in Saudi Arabia, with submission expected in the coming weeks, thereby enhancing treatment accessibility for bladder cancer patients in the region.
- ANKTIVA Expansion Discussions: ImmunityBio has initiated discussions with the SFDA regarding the expansion of ANKTIVA in combination with checkpoint inhibitors to additional tumor types, building on the accelerated approval granted in January 2026 for metastatic non-small cell lung cancer, which enhances the company's competitive position in the market.
- Clinical Trial Results: The QUILT-3.055 trial demonstrated that ANKTIVA rescues checkpoint inhibitor activity across multiple tumor types, with a median overall survival of 14.1 months in NSCLC patients, indicating its potential in tumor immunotherapy and possibly paving the way for future regulatory approvals.
- Regional Strategic Development: ImmunityBio plans to establish a regional office in Saudi Arabia to support physicians and patients across the Middle East and North Africa, reflecting the company's commitment to the market and accelerating the development and commercialization of innovative therapies through collaboration with the Saudi-USA Biotech Alliance.
See More
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- Regulatory Progress: ImmunityBio is advancing its regulatory efforts by engaging in productive discussions with the Saudi Food and Drug Authority, planning to submit a regulatory package for recombinant BCG in the coming weeks, which aims to address the global BCG shortage and significantly improve bladder cancer treatment accessibility in Saudi Arabia.
- Product Expansion: The company is exploring the use of Anktiva in combination with checkpoint inhibitors for various tumor types, supported by data from the QUILT-3.055 Phase 2b trial, which may enhance its market share by expanding indications in the relapsed patient population.
- Financial Performance: ImmunityBio anticipates that Anktiva will generate approximately $113 million in net product revenue for fiscal 2025, reflecting a remarkable 700% year-over-year increase, indicating strong market demand and product acceptance that could boost overall company performance.
- Stock Performance: The stock is currently priced at $6.04, trading 5.47% above its 20-day and 12.3% above its 100-day simple moving averages, indicating a strong short-term upward trend, with a 77.46% increase over the past 12 months, showcasing robust long-term performance.
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- ANKTIVA Expansion Discussions: ImmunityBio has initiated discussions with the Saudi Food and Drug Authority (SFDA) to explore the use of ANKTIVA in combination with checkpoint inhibitors for multiple tumor types, aiming to enhance the company's competitive position in the oncology immunotherapy market.
- Positive Market Reaction: Following the discussions with the SFDA, ImmunityBio's shares rose approximately 6% in premarket trading, reflecting investor optimism regarding the company's future regulatory submissions and market expansion, with plans to file within the next few weeks.
- Clinical Data Support: ANKTIVA received accelerated approval in Saudi Arabia in January 2026, with data from the QUILT-3.055 Phase 2b trial showing its ability to restore checkpoint inhibitor activity across various cancers, particularly in relapsed lung cancer patients, where the median overall survival reached 14.1 months, indicating significant therapeutic potential.
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See More
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See More
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- Industry-Wide Impact: The surge in ZIM's stock price could influence investor sentiment across the shipping industry, prompting fluctuations in the stock prices of other related companies and affecting overall industry performance.
- Increased Investor Attention: As the stock price rises, ZIM may attract more attention from analysts and investors, further driving its market performance and trading volume, thereby strengthening the company's competitiveness in the shipping market.
See More
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- Economic Data Focus: Investors are closely monitoring the upcoming ADP Weekly Employment Change and Empire State Manufacturing Index releases, as these data points could influence market sentiment and guide future investment decisions.
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