ImmunityBio's Core Product Sales Surge 750% Despite FDA Warning Over Marketing Practices

YaoRongQuan DataMonitoring shows: ImmunityBio is a vertically integrated, commercial-stage biotechnology company dedicated to developing next-generation immunotherapies for the treatment of cancer and infectious diseases. The company was founded by Chinese-American biotech mogulPatrick Soon-Shiong(Patrick Soon-Shiong,Previously translated by some media asPatrick Soon-Shiong)Founded.

March 24, 2026, was undoubtedly a Black Tuesday for investors in ImmunityBio (NASDAQ: IBRX). On that day, the biotechnology company’s stock price plummeted by 21%, with the trigger for this turmoil being the U.S. FDA’s public release of a letter directed at the companyWarning Letter。

Source: FDA

This is the first formal warning letter issued in 2026 by the U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP). Previously, the FDA had sent two lower-level “Untitled Letters” to Altor BioScience, an indirect wholly-owned subsidiary of ImmunityBio, in September 2025 and January 2026, reminding the company of compliance concerns; however, ImmunityBio continued to promote its core drug in a misleading manner.Anktiva（nogapendekin alfa inbakicept-pmln）. This drug is aIL-15Receptor Agonist, which can promote NK cells and CD8⁺Proliferation and activation of T cells and memory T cells, without inducing the proliferation of immunosuppressive regulatory T cells (Tregs).

Specifically, this review primarily targeted statements made by company executives—including Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Medical and Scientific Officer, and Richard Adcock, President and Chief Executive Officer—in television advertisements and podcast programs. The FDA pointed out that these materials contained false and misleading claims: Dr. Soon-Shiong claimed in a podcast that Anktiva could “treat all cancers” and even “prevent radiation-induced carcinogenesis,” describing it as a “cancer vaccine.” In fact, the drug is approved only for the treatment of specific types ofNon-muscle-invasive bladder cancer (NMIBC）, and it is not a vaccine; meanwhile, promotional materials describe it as a “single jab” administered via subcutaneous injection, which directly contradicts the FDA-approved indication of “for intravesical instillation only”; furthermore, television advertisements fail to prominently disclose drug side effects or relegate risk information to inconspicuous black screens, thereby undermining the communication of critical risk information.

In response to this warning letter, ImmunityBio issued a formal reply on April 6, addressing the controversyClarification and RectificationThe company explicitly stated that the controversial television advertisement was never publicly aired and has removed the podcast episode in question from its official website and third-party platforms. Addressing Dr. Patrick Soon-Shiong’s remarks on the podcast, the company clarified that these comments were primarily forward-looking statements based on scientific vision, rather than promotional claims for approved indications. Meanwhile, the company committed to implementing a series of enhanced compliance measures, including mandatory executive training, expanded protocols for the promotional review committee, and the engagement of external regulatory consultants for audits.

As of press time today, the market capitalization stood at $7.3 billion.

However, if we look beyond this regulatory turmoil, we find that ImmunityBio’s recent commercial fundamentals are actually quite robust. In its 2025 annual financial report released on February 23, the company delivered an impressive performance: net product revenue from its core product, Anktiva, reached1.13100 million USD, year-on-yearSurge of approximately700%, with sales volume increasing by approximately 750%.

Meanwhile, Anktiva’s global footprint is also expanding rapidly, with its regulatory presence already coveringUnited States (2024Year4monthly approval), the United Kingdom (2025Year7approved in [Month]), the European Union (2026Year2monthly approval), Saudi Arabia (2026Year1approved in [Month]) and Macau, China (2026Year3(Approved in [Month])The five major jurisdictions comprise a total of 34 countries. Notably, in January, the Saudi Food and Drug Authority (SFDA) approved Anktiva in combination with checkpoint inhibitors (CPIs) for treatmentNon-Small Cell Lung Cancer (NSCLC）, marking the first approved indication for this drug outside of bladder cancer.

At the capital level, the Company has likewise demonstrated strong resilience and potential. As of December 31, 2025, the total amount of cash, cash equivalents, and marketable securities held by the Company amounted to2.428USD 100 million. On March 31, in the aftermath of the warning letter controversy, the company announced the completion of1$100 million in financing, including a $75 million non-dilutive financing arrangement with Oberland Capital and related entities affiliated with the Executive ChairmanNant CapitalThe $25 million debt-to-equity swap transaction that was reached. This not only provided the company with sufficient operating capital, but also optimized its balance sheet through non-dilutive financing and debt reduction, sending a strong signal to the market of management’s firm confidence in the company’s long-term value.

Since the beginning of this year, ImmunityBio’s stock price has experienced a significant surge.

To truly understand ImmunityBio, one must mention its founderPatrick Soon-ShiongPh.D.business layout. As the founder who successfully established Abraxis BioScience (which developedThe World's First Albumin-Bound Paclitaxel) and sold it to Celgene. Dr. Soon-Shiong, a legendary scientist, founded ImmunityBio in 2014 with the aim of developing next-generation immunotherapies.

To maximize this vision, he spearheaded the collaboration between ImmunityBio andNantKwesta 100% stock-for-stock merger with the NK cell therapy company (also helmed by Dr. Soon-Shiong). This merger not only marked ImmunityBio’s official listing on the NASDAQ, but also united his two core assets in cellular therapy (NantKwest) and immune molecules (ImmunityBio), laying the foundation for the development of today’s vertically integrated biotech company.

ImmunityBio’s current core asset, Anktiva (nogapendekin alfa inbakicept-pmln), is afirst-in-classofIL-15AgonistIgG1Fusion ProteinIt consists of an IL-15 mutant (IL-15N72D) fused to the IL-15 receptor alpha chain. This fusion protein binds with high affinity to IL-15 receptors on NK cells, CD4+ T cells, and CD8+ T cells, mimicking the natural biological properties of membrane-bound IL-15 receptor alpha. It facilitates IL-15 presentation by dendritic cells, driving the activation and proliferation of NK cells while promoting the generation of memory cytotoxic T cells that retain immunological memory against such tumor clones.

However, the regulatory and commercialization path for Anktiva (development code N-803) has not been smooth. In May 2023, ImmunityBio hadReceived due to deficiencies in third-party manufacturing inspectionFDAFull Response Letter, which hindered the marketing application for Anktiva; in October of the same year, the company announced that the FDA had accepted the resubmitted application; on April 22, 2024, ImmunityBio announced that the FDA had officially approvedAnktivaCombined Bacillus Calmette-Guérin (BCG), for the treatment of cases with or without papillary tumorsBCGNon-responsive Non-Muscle-Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) Patient. Anktiva has also becomeThe first to receiveFDAApprovedNMIBCImmunotherapy. This approval not only marks the imminent commercial launch of the company’s first product, but also fills a long-standing therapeutic gap in this field.

Following its approval and market launch, Anktiva’s early sales ramp-up was significantly constrained, generating only $14.15 million in product revenue in 2024, largely attributable toUS Market BCG Vaccine (BCG) persistent shortage(Since 2012, Merck & Co. has been the sole supplier of BCG products in the United States), limiting the accessibility of combination therapy.

To break this impasse, on one hand, ImmunityBio and the world’s largest vaccine manufacturerSerum Institute of India (SII）Secure an exclusive partnership to ensure a continuous supply of standard BCG vaccine and next-generation recombinant BCG vaccine, thereby addressing production capacity bottlenecks at the source.

On the other hand, with the official implementation of the permanent J-code (J9028) exclusive to Anktiva in January 2025, the reimbursement process of the Centers for Medicare & Medicaid Services was simplified, greatly facilitating cost settlement for medical institutions and patient access. These two key initiatives quickly translated into strong sales momentum, leading to a significant increase in Anktiva’s sales volume in 2025 and marking an exit from the early challenges of commercialization.

To support the global commercialization of Anktiva, ImmunityBio has also established strategic partnerships and supporting infrastructure: in the European market, the company collaborates withAccord HealthcareHaving secured the partnership, it will deploy over 100 sales, medical, and marketing professionals across 30 countries in the European Union, the United Kingdom, and the European Free Trade Association (EFTA), and has already established an Irish subsidiary in Dublin to support its distribution and commercialization strategy in Europe. In the Middle East, ImmunityBio andBiopharma-meaandCigalah HealthcareEstablishing a partnership aimed at introducing Anktiva to Saudi Arabia, with plans for future expansion across the entire Middle East and North Africa (MENA) region; to this end, the company has also established a local subsidiary in Saudi Arabia.

As the core backbone of the company’s Cancer BioShield platform, ImmunityBio is advancing patient enrollment in pivotal randomized clinical trials of Anktiva across multiple therapeutic areas and plans to submit data from completed single-arm trials to implement its three-year global strategy, which primarily comprises three aspects:Combination with Standard Therapy, Synergy with Cell Therapy, and Treatment for Lymphopenia。

In combination with standard-of-care therapies, the Company is committed toConsolidate its leadership in bladder cancer and expand into major indications such as lung cancerIn the field of bladder cancer, ImmunityBio focuses not only on BCG-naïve non-muscle-invasive bladder cancer (NMIBC), but also addresses the needs of NMIBC patients who are BCG-unresponsive and present with papillary tumors without carcinoma in situ (CIS). In lung cancer, its portfolio covers first-line and second-line treatments for non-small cell lung cancer (NSCLC). Furthermore, this combination strategy extends to various solid tumors, including pancreatic cancer, hepatocellular carcinoma, and colorectal cancer. Meanwhile, the company supports an expanded access program for recombinant Bacillus Calmette-Guérin (rBCG) to help alleviate supply constraints in the United States.

In terms of synergy with cell therapy,AnktivaCurrently withCAR-NK(including those developed by the companyPD-L1 t-haNK、CD19 t-haNK) andM-ceNKDeep Integration of TechnologiesClinical trials evaluating the combination of Anktiva and CAR-NK cells in refractory solid tumors, such as pancreatic cancer, triple-negative breast cancer, and glioblastoma, have been completed or are currently underway. In the field of hematologic malignancies, trials targeting relapsed/refractory non-Hodgkin lymphoma are actively enrolling patients to explore convenient treatment regimens that do not require lymphodepletion. Meanwhile, the company is advancing its “Natural Killer Cell World Bank” initiative, leveraging M-ceNK technology to establish personalized cell therapy reserves for various tumor types.

In terms of lymphopenia strategy, Anktiva is developed to reverseCaused by sepsis (such as community-acquired pneumonia, withiNKTSevere lymphopenia induced by combination cell therapy, radiation therapy, or bispecific antibody therapy)This represents not only a breakthrough in supportive care but also opens up new avenues for its application in the fields of infectious diseases and critical care.

It is also worth noting that on March 17, 2026, the National Comprehensive Cancer Network (NCCN) expanded the indication for Anktiva in combination with BCG therapy in its latest clinical practice guidelines for bladder cancer, extending coverage from patients with carcinoma in situ (CIS) to includeNot associated withCISpatients with only papillary lesions (all were2AClass Recommendation). Although the recommendations for patients with only papillary lesions are currently still consideredFDAOff-labelclinical applications, butEndorsement by authoritative guidelines still accumulates critical leverage for the company’s subsequent communications with the FDA.

Additionally, it was disclosed that ImmunityBio has developed a therapeutic vaccine based on the hAd5 vector for HPV-related malignancies.IBRX-042; to address the challenges of immune dysfunction and drug resistance in advanced solid tumors, the company has launchedMemory-like Cytokine-Enhanced Natural Killer Cells (M-ceNK）project; in the field of infectious diseases, the company is exploring the use of Anktiva forHIVTreatment and Long COVID Treatmentpotential.

As ofAs of the market close on April 8, 2026, ImmunityBio’s total market capitalization stood at $7.176 billion. Financial report data disclosed on the 9th indicated that its performance for Q1 2026 amounted to $44.2 million.

PharmRong DataMonitoring shows that many Chinese pharmaceutical companies are developing IL-15 superagonists, such asFurong Bio(FL115, long-acting single-chain IL-15/IL-15Rα-Fc fusion protein), CSPC NovaBay, Jiangsu Hengrui Medicine, Shenghe Biotechnology, AskGene Pharma, etc.

References:

PharmaCircle Data;

pharma.bcpmdata.com (formerly PharmCloud Data);

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/immunitybio-inc-725468-03132026；

https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-addresses-fda-correspondence-and-reaffirms?field_nir_news_date_value[min]=；

https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-rep

orts-700-year-over-year-revenue-growth-expanded?field_nir_news_date_value[min]=；

https://www.businesswire.com/news/home/20260409585613/en/ImmunityBio-Reports-Net-Product-Revenue-Increased-Nearly-2.7-Times-Year-Over-Year-to-Record-%2444-Million-in-Q1-2026-and-%24381-Million-in-Cash-and-Marketable-Securities；

Other Relevant Public Information (Images in the text are sourced from the company’s official channels, unless otherwise noted).

This article is intended solely to provide scientific information to healthcare professionals, does not represent the platform’s position, and makes no medication recommendations.