IBRX Stock Rises Overnight: Investors Eye FDA Workshop On Anktiva After Exclusive Japan BCG Deal

• The FDA workshop will focus on whether CIS and papillary bladder cancer are biologically the same disease.
• ImmunityBio signed an exclusive agreement with a Japanese lab for the Tokyo-172 strain of BCG. 
• Soon-Shiong also promoted “Immunotherapy 2.0,” combining IL-15, NK cells and AI-driven tech.

Shares of ImmunityBio, Inc. (IBRX) climbed 2% in overnight trading heading into Monday as investors focused on two major catalysts: Monday’s FDA workshop for Anktiva’s expansion path and a new Japan BCG deal aimed at boosting bladder cancer treatment supply in the U.S.

IBRX stock fell more than 6% last week, marking its worst weekly decline in nearly two months. 

FDA Workshop Puts Anktiva Expansion In Spotlight

At the American Urological Association’s 2026 annual meeting held over the weekend, Soon-Shiong called Monday’s FDA workshop as “a pivotal meeting” that would address key questions related to ImmunityBio’s pending filing to expand the use of Anktiva, the company’s flagship immunotherapy, in bladder cancer treatment. 

The talks will center around whether carcinoma in situ (CIS) and papillary bladder cancer are essentially different forms of the same disease. Soon-Shiong said that the scientific evidence supports that view, which could help broaden Anktiva’s approved use to include patients with papillary-only non-muscle invasive bladder cancer, which is a larger patient group than its current FDA-approved indication.

ImmunityBio said in March that the FDA had accepted its resubmitted supplemental biologics license application after asking for additional efficacy data earlier this year. The filing included updated long-term results from the Quilt 3.032 study, where the company reported durable disease control and high rates of bladder preservation in papillary-only bladder cancer patients.

Soon-Shiong also said that the FDA’s 60-day review period had passed and the company was still awaiting feedback. He pointed to the National Comprehensive Cancer Network’s (CNNC) Category 2A endorsement for Anktiva plus BCG in papillary disease without CIS.

Exclusive Japan BCG Deal Validates Retail Speculation

On Saturday, ImmunityBio announced an exclusive U.S. agreement with Japan BCG Laboratory for the Tokyo-172 strain of BCG, giving the company a second potential supply source for a bladder cancer treatment that has faced shortages in the U.S. for years.

The deal gives ImmunityBio exclusive rights to develop and commercialize the Tokyo strain in the U.S. The company said the strain was supported by a large Phase III study showing it worked similarly to TICE BCG, the standard bladder cancer BCG treatment currently used in the U.S. ImmunityBio said it plans to work with the FDA on a potential approval for the Tokyo strain, while continuing its recombinant BCG partnership with Serum Institute of India.

During his AUA presentation, founder Patrick Soon-Shiong said that the company now had access to “TICE, recombinant BCG, and now the Tokyo strain,” calling it a“multi-source expanded supply” strategy to solve the long-running BCG shortage.

The announcement also validated months of speculation among retail traders who had closely tracked Soon-Shiong’s extended Japan trip last month. Some investors monitoring publicly available flight data had speculated that the unusually long Tokyo visit signaled a major partnership or expansion deal in the works.

Founder Highlights Risks Of Bladder Removal

Over the weekend, Soon-Shiong intensified his public push around bladder-preserving therapies and highlighted on X the complications associated with radical cystectomy, or surgical bladder removal after his AUA26 appearance.

“Radical cystectomy (surgical removal of the bladder) — The largest complication in all surgeries even more than pancreatectomies (Whipple) which I used to do! Imagine if we can avoid this surgery,” he said. During the AUA presentation, Soon-Shiong said that Anktiva’s IL-15 mechanism may help address lymphopenia and improve immune-system activity through NK cells and T cells. 

‘Immunotherapy 2.0 On The March’

Alongside the bladder cancer updates, Soon-Shiong outlined over the weekend broader ambitions for “Immunotherapy 2.0.” In multiple posts, he discussed combining IL-15 stimulation, NK cells and T cells with AI, advanced antibody engineering and photonics tech being developed across NantWorks companies.

“Immunotherapy 2.0 on the march. Unstoppable,” Soon-Shiong said on X. He also said that NantWorks would begin unveiling tech developed “in stealth mode” over the past 15 years across healthcare, AI, climate and advanced computing infrastructure. NantWorks, founded by Soon-Shiong, is the parent company for a network of public and private entities focused on healthcare and life sciences, renewable energy, communications and connectivity technologies. 

Soon-Shiong also highlighted NantPhotonics and silicon lithium-niobate photonics tech that can move “data at the speed of light,” while suggesting future AI could help target intracellular proteins and activate immune-system responses. 

“Many will act synergistically with each company in helping us address life threatening and chronic diseases such as cancer, sepsis, autoimmune diseases, diabetes,” he said.

How Do Retail Traders Feel About IBRX?

On Stocktwits, retail sentiment for IBRX was ‘bullish’ amid ‘normal’ message volume.

One user said, “This is what you call unheard of territory. The good Dr. is on to something huge. Hang on to your golden tickets”

Another user said, “talking about a long term investment yes, for me, out of 4 stocks that I am swing trading IBRX is the only stock  that I am accumulating, meaning buy as much as I can on any dips and never sell a single share and hold till 2028-2030.”

IBRX stock has jumped 199% over the past year. 

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