Biotech Company Achieves Key Bladder Cancer Milestone in California

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1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

ImmunityBio Inc. (IBRX:NASDAQ) gave an update on March 26, 2026, regarding the trial of their drug, Anktiva, in combination with the clinically-approved drug, Bacillus Calmette-Guérin (BCC), for treating specific types of bladder cancer.

ImmunityBio announced that, "based on the Independent Data Monitoring Committee (IDMC) review of the interim data, the committee recommended that the study is adequately powered to detect the pre-specified clinically meaningful difference in complete response (CR) rate between the experimental arm (ANKTIVA + BCG) and the control arm (BCG alone) at the protocol-specified power, in the randomized QUILT-2.005 (NCT02138734) study."

ImmunityBio reached capacity for trial enrollment in late February 2026 and announced in March that the IDMC interim analysis of the study indicated that no further participants are required — e.g., the study has sufficient statistical power to see if combining the Anktiva and BCC presents a measurable change in treatment outcome.

Patrick Soon-Shion, M.D., and Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio, said, "Over the past decade, our scientific thesis has been that activating natural killer cells and CD8+ cytotoxic T cells through IL-15 receptor agonism would generate durable immunological memory against bladder cancer. The NCI identified IL-15 as the number one-ranked immunostimulatory cytokine nearly two decades ago, and this program has been the clinical validation of that thesis. The IDMC's confirmation that QUILT-2.005 is adequately powered to detect clinically meaningful differences when ANKTIVA is combined with BCG. Among participants from the QUILT 2.005 Phase 1b study, which began in 2014, those patients who enrolled in long-term follow-up (6 of 9 evaluable), all (6 out of 6, 100%) demonstrated a prolonged duration of complete remission with a median survival of 8.8 years with ongoing bladder preservation to date. In addition, the initial interim analysis of QUILT-2.005 performed in the first 43 patients in 2023 further demonstrated a difference in durable complete response when ANKTIVA is combined with BCG in the BCG-naïve setting. The consistency of durable response from the first 9 patients in 2014, to the next 43 patients in 2023 is encouraging, and I am pleased that statistical power of the randomized trial requires no further enrollment."

Soon-Shion went on to note that the company is on track to submit a supplemental Biologics License Application (BLA) in Q4 of this year, based on the current analyzed data.

ImmunityBio Inc. is an American immunotherapy company based in California that has "progressed into a clinical-stage biotechnology company with 27 clinical trials — 18 of which are in Phase 2 or 3 development — across 13 indications in liquid and solid tumors."

On its website, the company describes Anktiva as, ". . . the first FDA-approved immunotherapy designed to activate the body's natural immune system to target and attack BCG-unresponsive non-muscle invasive bladder CIS (NMIBC CIS), potentially leading to a long duration of complete response with some patients exceeding 53+ months."

A Hot and Cold Biotech/Pharma Market

In a March 26, 2026, article for Fierce Biotech, Nick Paul Taylor wrote that pharma funding had fallen from 2024 but noted that, "2025 was still the third-best year of the past decade. Similarly, overall funding was well above the pre-pandemic norm and only topped by 2020, 2021, and 2024."

In contrast, J. Edward Moreno of Sherwood News reported on January 14, 2026, that, "In 2025, announced global biotech deals totaled US$228.4 billion, up from US$132.3 billion in 2024, data from Dealogic shows . . . Just two weeks into 2026, US$9.2 billion in deals have been announced."

Moreno went on to add that movement is expected in the sector: "As some of the most lucrative drugs lose exclusivity in the next few years, pharmaceutical giants are increasingly shopping around for biotechs to add to their portfolios — and they are more than happy to pay a hefty premium for the right company . . . For some Big Pharma companies, business development spending is now about equal to, or more than, research and development."

Moreno's statement could explain the drop investors are beginning to see in research and development spending at biotech and pharma companies. On March 25, 2026, BioSpace's Annalee Armstrong reported that, "R&D spending at the top 16 pharmaceutical companies declined by 3.6% overall in 2025, as many aggressively cut spending and refocused pipelines."

Concerns With the FDA

Recently, the FDA criticized Founder, Executive Chairman Soon-Shion's representation of Anktiva via TV ads and podcasts.

"In a March 13 warning letter to ImmunityBio, which is primarily owned and controlled by Soon-Shiong, the agency found fault with numerous comments about the therapy, called Anktiva. The drug is marketed as a treatment for a type of bladder cancer, but the FDA noted both the ad and podcast suggested it was able to treat 'all cancers'," reported Ed Silverman for Stat News on March 13, 2026.

The company faced further concern that it may downplay risks of side effects, make promises of 'cures' that are not supported by data, and omit that Anktiva must be paired with a vaccine.

Analysts Rate the Stock a Buy

Analyst Jason Kolbert of D. Boral Capital assigned ImmunityBio a 'Buy' rating on March 26, 2026, reasoning that the company's drug trial update, "helps de-risk execution around the trial design and enrollment assumptions while preserving the company's stated path to final analysis and a supplemental BLA submission in 2026, rather than changing the underlying development timeline or introducing a new clinical hurdle."

Kolbert cautioned that results are still pending and offered a price target of US$23.00.

For H.C. Wainwright & Co., analysts Andres Maldonado and Andrew Fein also issued a 'Buy' rating, but with the lower price target of US$15.00.

They said that ImmunityBio's trial update, "meaningfully strengthens the commercial and clinical positioning of ANKTIVA within NMIBC, particularly by expanding its relevance into papillary-only disease, a sizable segment with limited approved options."

Catalysts

Looking to the future, Richard Adcock, President and CEO of ImmunityBio, said, "With ANKTIVA approved with BCG for adult patients with BCG-unresponsive NMIBC CIS with or without papillary disease in 34 countries and territories, the opportunity to extend its use earlier in the disease course in the BCG-naïve setting represents a substantial expansion of the addressable patient population."

The company plans to file a supplemental BLA later this year.

Ownership & Share Structure¹

ImmunityBio Inc. has a market cap of US$8.3 billion and 1.03 billion shares outstanding.

Institutions own 16.89% of shares, while Strategic Investors own 60.33%. Management & Insiders hold 3.32% of shares, and the remaining 19.46% are held by Retail.