ImmunityBio Inc (IBRX)

Read today that J&J is on the verge of developing a cancer cure that leverages the human immune system. I wonder if they have been studying Anktiva and messing around with reverse engineering without breaking any laws? https://www.foxnews.com/health/cure-certain-cancers-realistic-goal-next-decade-pharma-lead-says

On CNBC's “Mad Money Lightning Round,” Jim Cramer ...

When asked about ImmunityBio, Inc. (IBRX) , he said, “I will tell you, that's going to be your spec. Remember, in ‘How to Make Money in Any Market,’ I encourage speculation, as long as it's only one position. If you go to two positions, then I don't encourage it. Let Immunitybio (IBRX) be your speculation.”

As per the recent news, ImmunityBio (IBRX), on June 1, presented data at the American Society of Clinical Oncology Annual Meeting about its Phase 3 studies in advanced non-small cell lung cancer.

It seems a bit bogged down in the last few weeks.
The 5.50-6.00 target could be a reality...

The only Senator dumber than Johnson is Tuberville.

Andrew and I are in Washington, D.C. today, where I had the honor of testifying before the FDA on behalf of cancer patients everywhere.
We’re fighting to bring #ANKTIVA and natural killer (NK) cell therapies into the spotlight, giving hope and new options to those who need them… pic.twitter.com/wQG7RVkghr— Lori Mills (@LoriMills4CA42) June 4, 2026

Senator Johnson is getting involved. He actually gave both PSS and Anktiva a call out by name! That's HUGE! ImmunityBio is definitely on the precipice of going mainstream:

Senator Ron Johnson says mainstream media used to do serious journalism on vaccine injuries.

Before Big Pharma became one of the biggest advertisers in news.

“Prior to 1997, there was serious journalism covering suspected vaccine injuries.”

“Mike Wallace reported on CBS’s 60… pic.twitter.com/d5Z6eFNfjB— MAHA Action (@MAHA_Action) June 3, 2026

ImmunityBio Presents New Clinical and Comparative Data Across Lung and Bladder Cancer at ASCO 2026June 1, 2026 1:51 PM
Business Wire Presentations highlight ANKTIVA®-based approaches in non-small cell lung cancer (NSCLC) and non-muscle invasive bladder cancer (NMIBC) ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced two poster presentations and one online publication at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2, 2026, in Chicago. The presentations span two randomized Phase 3 trials in advanced NSCLC and a matched adjusted indirect comparison (MAIC) in BCG unresponsive non-muscle invasive bladder cancer (NMIBC), and collectively evaluate ANKTIVA® (nogapendekin alfa inbakicept-pmln), the company’s IL-15 receptor agonist immunotherapy designed to activate natural killer (NK) cells, CD4+ and CD8+ T cells, and memory T cells, across multiple solid tumor indications. “ASCO provides an important opportunity to share emerging clinical and translational data that continue to deepen our understanding of how ANKTIVA-based immunotherapy may restore immune function and rescue or reinvigorate the response to checkpoint inhibitors,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “ANKTIVA is the first FDA-approved immunotherapy designed to stimulate NK cells, CD4+ and CD8+ T cells, and memory T cells, which are the very immune cells that are depleted in patients with lymphopenia and that are critical to mounting an effective anti-tumor response. Growing long-term survival data across bladder, lung and other solid tumors are beginning to put in focus a compelling hypothesis: that restoring immune competence and addressing lymphopenia may be as a fundamental to cancer care as targeting the tumor itself. These findings reinforce our conviction that the future of immunotherapy lies in activating and amplifying the immune system, not suppressing it.” Presentation highlights include: ASCO 2026 Annual Meeting Poster Presentations - Sunday, May 31st (9am-12pm)? Poster Title: Phase 3 trial ResQ201A of nogapendekin alfa inbakicept (NAI) plus tislelizumab and docetaxel vs. docetaxel monotherapy for advanced or metastatic NSCLC resistant to ICI therapy ?Poster Board: 455a?m Abstract: #TPS8671? Presenter: Andreas Saltos (Affiliation: Moffitt) Poster Title: Efficacy outcomes in first line (1L) non–small cell lung cancer (NSCLC) with maintenance of immune competence: QUILT-2.023 randomized phase 3 study of IL-15R agonist nogapendekin alfa inbakicept (NAI) with checkpoint inhibitor (CPI) ± chemotherapy Poster Board: 378? Abstract: #8588? Presenter: John Wrangle (Affiliation: MUSC) Online Publication Only Abstract Title: A matched adjusted indirect comparison (MAIC) of NAI+BCG & pembrolizumab in patients with BCG unresponsive NMIBC with CIS ± papillary disease – Will be published on http://asco.org/abstracts at 5:00 PM EDT on May 21, 2026 About ANKTIVA® (nogapendekin alfa inbakicept-pmln) The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor superagonist, ANKTIVA® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the clinical development of ANKTIVA® (nogapendekin alfa inbakicept-pmln), the potential benefits of ANKTIVA-based immunotherapy in non-small cell lung cancer (NSCLC) and non-muscle invasive bladder cancer (NMIBC), future regulatory submissions and approvals, commercialization plans and market potential, and the company's strategic vision for restoring immune competence in cancer patients. These forward-looking statements are based on ImmunityBio's current expectations and beliefs and are subject to uncertainties and factors that could cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, but are not limited to: the risk that clinical trials may not demonstrate adequate safety and efficacy to support regulatory approval or may be delayed or terminated; the risk that regulatory authorities may not approve ANKTIVA for additional indications or may impose restrictions on its use; the risk that the company may not successfully commercialize ANKTIVA or achieve market acceptance; competition from other therapies; manufacturing and supply chain risks; intellectual property risks; and the company's ability to obtain additional funding to support its operations. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026 as well as its Form 10-Q filed with the SEC on May 7, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260601924208/en/ ImmunityBio Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com Media
Sarah Singleton
ImmunityBio, Inc.
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Sarah.Singleton@ImmunityBio.com Original: ImmunityBio Presents New Clinical and Comparative Data Across Lung and Bladder Cancer at ASCO 2026

ImmunityBio Presents New Clinical and Comparative Data Across Lung and Bladder Cancer at ASCO 2026
IBRX | 3 minutes ago
Presentations highlight ANKTIVA®-based approaches in non-small cell lung cancer (NSCLC) and non-muscle invasive bladder cancer (NMIBC)

ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced two poster presentations and one online publication at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2, 2026, in Chicago.

The presentations span two randomized Phase 3 trials in advanced NSCLC and a matched adjusted indirect comparison (MAIC) in BCG unresponsive non-muscle invasive bladder cancer (NMIBC), and collectively evaluate ANKTIVA® (nogapendekin alfa inbakicept-pmln), the company’s IL-15 receptor agonist immunotherapy designed to activate natural killer (NK) cells, CD4+ and CD8+ T cells, and memory T cells, across multiple solid tumor indications.

“ASCO provides an important opportunity to share emerging clinical and translational data that continue to deepen our understanding of how ANKTIVA-based immunotherapy may restore immune function and rescue or reinvigorate the response to checkpoint inhibitors,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “ANKTIVA is the first FDA-approved immunotherapy designed to stimulate NK cells, CD4+ and CD8+ T cells, and memory T cells, which are the very immune cells that are depleted in patients with lymphopenia and that are critical to mounting an effective anti-tumor response. Growing long-term survival data across bladder, lung and other solid tumors are beginning to put in focus a compelling hypothesis: that restoring immune competence and addressing lymphopenia may be as a fundamental to cancer care as targeting the tumor itself. These findings reinforce our conviction that the future of immunotherapy lies in activating and amplifying the immune system, not suppressing it.”

Presentation highlights include:

ASCO 2026 Annual Meeting Poster Presentations - Sunday, May 31st (9am-12pm)?

Poster Title:Phase 3 trial ResQ201A of nogapendekin alfa inbakicept (NAI) plus tislelizumab and docetaxel vs. docetaxel monotherapy for advanced or metastatic NSCLC resistant to ICI therapy ?Poster Board: 455a?m Abstract: #TPS8671? Presenter: Andreas Saltos (Affiliation: Moffitt)
Poster Title:Efficacy outcomes in first line (1L) non–small cell lung cancer (NSCLC) with maintenance of immune competence: QUILT-2.023 randomized phase 3 study of IL-15R agonist nogapendekin alfa inbakicept (NAI) with checkpoint inhibitor (CPI) ± chemotherapy Poster Board: 378? Abstract: #8588? Presenter: John Wrangle (Affiliation: MUSC)
Online Publication Only

Abstract Title:A matched adjusted indirect comparison (MAIC) of NAI+BCG & pembrolizumab in patients with BCG unresponsive NMIBC with CIS ± papillary disease – Will be published on http://asco.org/abstracts at 5:00 PM EDT on May 21, 2026
About ANKTIVA® (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IBRX and the BCG Shortage: Deals That Could Expand Demand
Sundeep Ganoria May 29, 2026
MRK Quick QuoteMRK URGN Quick QuoteURGN IBRX Quick QuoteIBRX

Zack's Triangle IconBetter trading starts here.


ImmunityBio signed an exclusive U.S. deal for Tokyo-172 BCG to improve long-term supply access.
IBRX seeks broader NMIBC use as FDA reviews a papillary-only label expansion by Jan. 2027.
ImmunityBio received five U.S. patents for Anktiva plus BCG, extending protection through 2035.
ImmunityBio (IBRX Quick QuoteIBRX - Free Report) is trying to turn a persistent bottleneck in bladder cancer care into a durable demand driver. The long-running U.S. Bacillus Calmette-Guérin (BCG) shortage has created a structural “pull” for regimens that can improve treatment availability and keep patients on schedule.
That backdrop matters because Anktiva plus BCG is already the company’s commercial engine in non-muscle invasive bladder cancer (NMIBC). If supply reliability improves, the shortage itself can become a catalyst that expands practical adoption over time.

IBRX Thesis Hook: A Structural Supply Problem Meets a New Regimen
ImmunityBio is not relying on a single path to improve BCG access. One approach is continued access to investigational recombinant BCG through an FDA expanded access program, which supports continuity while broader supply options are pursued.

The second pillar is a newly announced exclusive U.S. development and supply agreement for the Tokyo strain of BCG with Japan BCG Laboratory. Together, these parallel tracks are designed to create multiple sources that could reduce supply fragility.

IBRX Tokyo-172 Agreement: What It Signals for Strategy
The Tokyo-172 agreement grants ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo strain BCG. The company plans to engage the FDA on a U.S. approval pathway and intends to serve as the sole biologics license application holder for the product.
Strategically, the agreement is positioned as more than a supply contract. The goal is to improve reliability over time and strengthen the company’s standing with urologists by supporting consistent access in a market where interruptions can disrupt care patterns.

ImmunityBio’s Bladder Expansion Path Amplifies the Supply Angle
Supply matters even more if the eligible population expands. ImmunityBio is working to broaden Anktiva plus BCG use within NMIBC, pushing the regimen beyond its existing setting in BCG-unresponsive disease with carcinoma in situ (with or without papillary tumors).
Guideline support is already moving in that direction. The National Comprehensive Cancer Network has updated its bladder cancer guidelines to include Anktiva plus BCG for BCG-unresponsive papillary-only disease, in addition to carcinoma in situ settings, and both are listed as Category 2A.

Regulatory timing is also defined. The FDA has accepted a filing seeking approval for the papillary-only label expansion, with a final decision expected by Jan. 6, 2027. That review timeline keeps attention on execution while the company continues to build demand from new prescribers and repeat ordering.



IBRX IP Wins Add Durability to the Bladder Franchise
Intellectual property is another durability lever alongside supply. ImmunityBio received five U.S. patents covering the combination of Anktiva plus BCG for NMIBC, extending protection through 2035.
The patent coverage spans multiple layers of the regimen, including methods of treating NMIBC, pharmaceutical compositions, dosing regimens, and the company’s two-vial commercial kit. That breadth can help protect the franchise while the company pursues additional NMIBC expansion paths.

ImmunityBio’s Execution Risks Still Apply in a “Trend” Story
Even with structural tailwinds, execution risk remains. International launches are described as stepwise, with Europe requiring country-by-country reimbursement and an initial focus on major markets, implying a ramp that can extend into 2027. Friction in access decisions can keep near-term results disproportionately tied to the U.S. trajectory.
Concentration risk is also clear. Revenue is primarily driven by Anktiva, and the competitive environment is described as intense, making any pipeline or regulatory setback more consequential for the equity story.

Finally, regulatory and legal overhangs can distract management. The company received FDA promotional correspondence and implemented enhanced review protocols, adding another layer of operational complexity as commercialization and pipeline investment continue.

What to Watch Next for IBRX if Supply Becomes a Catalyst
The next phase hinges on measurable follow-through. First, investors should watch for continued strength in U.S. demand, which management has tied to new prescribers, broader use across eligible patients, and repeat ordering that includes maintenance.
Second, track tangible milestones on BCG supply pathways. Progress on the Tokyo-172 regulatory engagement plan, alongside continued access routes such as the expanded access program for investigational recombinant BCG, is central to the reliability thesis.

Third, monitor regulatory momentum toward broader NMIBC use, including the FDA decision date for the papillary-only filing and ongoing guideline support. If these elements align, the mechanisms at work can support a larger, more durable bladder franchise over time.

In a bladder cancer landscape where large oncology players like Merck (MRK Quick QuoteMRK - Free Report) compete with established immunotherapy franchises and smaller uro-oncology specialists like UroGen Pharma (URGN Quick QuoteURGN - Free Report) target non-muscle invasive disease, ImmunityBio’s 2026 will likely come down to two things: sustaining U.S. adoption while proving Anktiva can move earlier in care.

IBRX’s Zacks Rank
ImmunityBio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Research Chief Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.

This company targets millennial and Gen Z audiences, generating nearly $1 billion in revenue last quarter alone. A recent pullback makes now an ideal time to jump aboard. Of course, all our elite picks aren’t winners but this one could far surpass earlier Zacks’ Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months.

The underlying data heading into the June Russell Reconstitution shows that $IBRX is sitting on a massive powder keg of competing market forces.
On one side, institutional "sticky" money has steadily scaled up, establishing a solid baseline of long-term support. On the other side, short sellers have heavily crowded into the trade, setting up a high-stakes tug-of-war exactly as passive index buying is forced to kick in. 
Here is how the numbers stack up right now:
1. Institutional Ownership: Building a Strong Baseline
Institutional filings reveal that major fund managers have aggressively built up their long positions. 
The Big Three Heavyweights: Vanguard, BlackRock, and State Street hold massive anchor positions. In their most recent disclosures, Vanguard holds over 32.7 million shares, BlackRock controls over 26.3 million shares, and State Street has climbed to 17.7 million shares. 
Smart Money Clusters: Other major quant and hedge fund players like Geode Capital Management (8M+ shares) and Two Sigma Investments (4.3M+ shares) are firmly entrenched. 
The Indexing Catalyst: Because index giants like Vanguard and BlackRock manage both active funds and passive products, their baseline familiarity with the stock means the plumbing is already in place. Once the Russell 2000/3000 inclusion becomes official on June 26th, their passive index-tracking ETFs (like the Vanguard Total Stock Market ETF and the Vanguard Small-Cap ETF) will be legally forced to buy millions more shares to lock in the proper index weightings.
2. Short Interest: A Highly Crowded Trade
While the institutions are buying the floor, short sellers have pinned a giant target on the stock. $IBRX has quietly become one of the most heavily shorted biotechs on the street. 
Short Interest % of Float: The official short interest is sitting between 33.6% and 37.0% of the float. For context, anything north of 20% is considered incredibly high; pushing past 33% puts $IBRX in rare air. 
Volume Out of Balance: Total short interest sits at roughly 132 million to 140 million shares bet against the company. 
Days to Cover: Based on average daily trading volumes, the Days to Cover ratio is roughly 7.8 to 9.5 days. This means if every short seller tried to buy back their shares tomorrow to exit their positions, it would take more than a full week of average daily trading volume just to clear the order book.
The Convergence: The Reconstitution Collision
This setup is exactly why the June 26th reconstitution date is so critical.
When a stock with a 35% short interest meets a massive, inflexible wave of forced institutional buying (passive index funds cannot choose to "wait for a better price"—they must buy on the rebalance date), it creates a structural liquidity mismatch.
If the forced buying pressure from the Russell inclusion begins driving the price up, those short sellers facing a 9-day escape hatch can easily find themselves in a squeeze, rapidly compounding the upward volume. It makes the final weeks of June an incredibly volatile window to watch.

Market Impact Note: The final day of the reconstitution (June 26th) is historically one of the highest-volume trading days of the entire year. This is the exact window where passive index funds and institutional managers tracking the Russell 2000/3000 must simultaneously buy shares of new additions to mirror the updated index weights, which frequently triggers massive volume spikes for incoming stocks like $IBRX.

Yes, ImmunityBio ($IBRX) is included in the 2026 Russell Reconstitution.
The company made the cut on the initial, key preliminary list that FTSE Russell published after the closing bell last Friday, May 22nd.
Because FTSE Russell uses a snapshot of market capitalizations from Rank Day (April 30, 2026) to determine index eligibility, $IBRX comfortably met the criteria. With a market cap hovering well above the minimum entry floor, it is slated to join both the broad market Russell 3000 and the small-cap Russell 2000 indexes. 
What to Expect Tonight and Beyond
The list dropping after the closing bell tonight (Friday, May 29th) is the first of several weekly updates designed to catch data corrections, corporate structural updates, or sudden changes before everything is locked in. 
Barring any bizarre, unforeseen data or regulatory exclusions, $IBRX's spot is essentially locked. The remaining timeline for the index rebalance plays out as follows:
May 29, June 5, June 12, June 19: FTSE Russell publishes updated preliminary weekly lists after 6:00 PM ET to manage any minor revisions. 
Friday, June 26, 2026: The final reconstitution takes effect after the market close.

The $13 Million Company Teaching the Immune System to Hunt CancerMay 29, 2026 9:00 AM
PR Newswire (US) Issued on behalf of GT Biopharma, Inc. (NASDAQ: GTBP)Three drugs in human trials. A platform licensed from one of the world's top cancer-research universities. A market cap smaller than a Manhattan apartment. For investors willing to look where almost no one is looking, GT Biopharma is the kind of asymmetric setup that biotech is built on.NEW YORK, May 29, 2026 /PRNewswire/ -- USA News Group Market Commentary - Start with the number that makes everyone do a double take. As of mid-May 2026, GT Biopharma (NASDAQ: GTBP) carried a market capitalization of roughly $13 million. Thirteen million. That is not a typo, and it is not a shell company. It is a clinical-stage immuno-oncology company with three separate drug candidates already dosing patients in human trials, a technology platform exclusively licensed from the University of Minnesota, and a scientific approach that the largest names in cancer immunotherapy are spending billions to pursue. See the full GT Biopharma investor breakdown at USA News Group ?That gap — between what the company is doing in the clinic and what the market is paying for it — is the entire story. Whether it closes, and in which direction, is the question every investor reading this should be weighing right now.The idea: don't build a new weapon, sharpen the one you already haveMost cancer therapies try to bolt something new onto the body — a manufactured cell, a synthetic antibody, a toxic payload. GT Biopharma's approach is different, and once you understand it, it's hard to forget.The human immune system already contains a class of cells whose entire job is to find and destroy abnormal cells: natural killer cells, or NK cells. They are the immune system's first responders, patrolling the body and killing threats without needing to be "trained" first. The problem in cancer is that tumors learn to hide from them. GT Biopharma's platform, called TriKE® — short for Tri-specific Killer Engager — is designed to drag those NK cells directly onto the tumor and switch them on.A TriKE molecule is engineered with three parts joined together. One arm grabs the NK cell by a receptor called CD16. A second arm grabs the cancer cell by a marker on its surface. And in the middle sits a molecule called IL-15, which acts like a shot of adrenaline, keeping the NK cell alive and multiplying once it's locked onto its target. The result, in concept, is elegant: you take the body's existing assassins, handcuff them to the tumor, and tell them to get to work.The platform was developed at the University of Minnesota, and GT Biopharma holds an exclusive worldwide license to develop and commercialize therapies based on it. This is not a science project the company dreamed up in isolation — it's institutional research that GTBP has the rights to turn into medicine.Why now: three shots on goal, all liveWhat changed in 2026 is that GT Biopharma stopped being a one-drug story. As of this spring, the company has advanced three TriKE candidates into the clinic — a milestone its leadership rightly calls a turning point.Track every clinical milestone on the GTBP catalyst timeline ?The lead program is GTB-3650, aimed at relapsed or refractory CD33-positive blood cancers — specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS), two of the most treatment-resistant cancers in oncology. It is the first TriKE built on camelid nanobody technology — antibody fragments derived from the same family as llamas and alpacas, prized for being small, stable, and able to penetrate tissue. The Phase 1 dose-escalation trial began enrolling in early 2025 and has moved methodically upward through its dose cohorts. As of the company's Q1 2026 report in May, Cohort 4 enrollment was complete with eight patients treated across the first four cohorts — and, critically, the earlier safety reviews advanced without the dose-limiting toxicities that derail so many early trials. The study can escalate through up to seven cohorts, and management has guided to a meaningful data update in the second half of 2026.The newest program is where the ambition becomes obvious. In May 2026, GT Biopharma dosed the first patient in the Phase 1 trial of GTB-5550, a TriKE targeting a protein called B7-H3. Here is why that matters: B7-H3 is expressed on a huge range of solid tumors, and in metastatic castration-resistant prostate cancer it appears in over 90% of tumors. The trial begins with a prostate-cancer-focused dose escalation, then expands into a "basket" across as many as seven solid tumor types — prostate, ovarian, breast, head and neck, non-small cell lung, pancreatic, and bladder. In the company's own framing, the solid-tumor patient population GTB-5550 targets is "orders of magnitude larger" than the blood-cancer population of its lead drug. And GTB-5550 uses subcutaneous dosing — a simple injection rather than an infusion — which the company describes as more patient-friendly, a quiet but real commercial advantage if the drug works.Three programs. Two cancers as different as liquid and solid tumors. One underlying platform. That is the shape of a company trying to prove a technology, not just a single molecule.The market it's chasing is enormousThe backdrop here is not subtle. The global oncology market is projected to nearly double from roughly $139 billion in 2025 to about $268 billion by 2034. Solid tumors alone represent a market estimated in the hundreds of billions of dollars, and B7-H3 — GTB-5550's target — shows up across many of the most common and lethal of them. NK-cell-directed immunotherapy has become one of the most closely watched frontiers in the entire sector, precisely because it offers the prospect of harnessing the immune system with potentially fewer of the brutal side effects of conventional treatment.Why NK-cell therapy is biotech's hottest frontier — read the deep dive ?When a tiny company is pointed at a market that large, the math of asymmetry takes over. It does not require GT Biopharma to win the whole field. It requires only that one of its three shots connects — and that the market eventually notices a company priced near $13 million is playing in an arena measured in the hundreds of billions.How GT Biopharma stacks up against its NK-cell peersThe most useful way to understand GTBP's positioning is to look at the company it keeps. NK-cell and immune-engager therapy is a crowded, well-funded field — and the contrast in scale is the entire investment argument.ImmunityBio (NASDAQ: IBRX) is the proof of concept that NK-cell immunotherapy can reach the market. Its NK-activating therapy ANKTIVA is FDA-approved for bladder cancer, the company reported roughly $44 million in product revenue in Q1 2026 and held some $381 million in cash, and it is now scaling NK-cell manufacturing to billions of cells per batch. ImmunityBio is what NK-cell success looks like at commercial scale — and a reminder of the valuation gap a clinical-stage peer could theoretically narrow if its data delivers.Fate Therapeutics (NASDAQ: FATE) is the deep-pocketed platform play, engineering off-the-shelf NK and CAR-T cell therapies from induced pluripotent stem cells, with roughly $175 million in cash and a runway management has guided into 2028. Fate illustrates how richly the market will fund an NK/cell-therapy platform it believes in — a striking counterpoint to GTBP's microcap valuation.Nkarta (NASDAQ: NKTX) is the engineered-NK-cell specialist, advancing its platform into autoimmune disease and backed by a market capitalization and cash position orders of magnitude above GT Biopharma's. Nkarta shows that NK-cell companies can command substantial valuations well before commercialization, on the strength of platform potential alone.Artiva Biotherapeutics (NASDAQ: ARTV) rounds out the set as the allogeneic, off-the-shelf NK-cell developer whose lead candidate AlloNK is heading toward a Phase 3 registrational trial in refractory rheumatoid arthritis in 2026. Artiva demonstrates how far and how fast an NK-cell program can advance through the clinic — the kind of trajectory GTBP investors are betting its TriKE platform can follow.Set GT Biopharma beside those four names and the picture sharpens. They are pursuing variations of the same fundamental thesis — unleash NK cells against disease — and the market has assigned them valuations ranging from the hundreds of millions into the billions. GT Biopharma, with three candidates already in the clinic, sits near $13 million. Either the market has correctly priced a struggling microcap, or it has badly overlooked a platform company in the same arena as far larger peers. That is the bet, stated plainly.The risks, stated honestlyNo serious investor case is complete without the other side of the ledger, and GT Biopharma's is real.This is a clinical-stage company with no approved products and no product revenue. Its cash balance was approximately $9 million at the end of Q1 2026, which management expects to fund operations only through the fourth quarter of 2026 — meaning additional financing, likely dilutive to existing shareholders, is a near-certainty rather than a possibility. The stock trades well under a dollar and far below its 52-week high, and a Roth Capital analyst, while maintaining a Buy rating, cut the price target to $3 from $8 earlier this year. Phase 1 trials are designed to test safety, not to prove a drug works; the encouraging absence of dose-limiting toxicities and the early signs of NK-cell activation are genuinely positive, but they are not efficacy. Most drugs that enter Phase 1 never reach the market. And the very peers that make GTBP look cheap are also formidable competitors with vastly greater resources.In short: this is a high-risk, binary-outcome situation. It is exactly the kind of company that can multiply many times over on a single strong data readout — and exactly the kind that can be forced into painful dilution or worse if the data disappoints or the financing window closes. Both outcomes are live.The bottom lineGT Biopharma is a study in asymmetry. On one side: a roughly $13 million valuation, a sub-dollar stock, a thin cash runway, and all the risk that comes with clinical-stage biotech. On the other: three drugs dosing patients, a platform licensed from a top-tier research university, a mechanism the biggest players in immuno-oncology are validating with their own R&D budgets, and a pair of catalysts — GTB-3650 data and GTB-5550 progress — both expected in the second half of 2026.That is the setup. A company priced for failure, sitting on a platform built for something much larger, with hard data events on the calendar in a matter of months. For investors who understand that the biggest biotech returns come from the names the market has written off just before it's forced to reconsider, GT Biopharma is a story worth watching very closely between now and year-end.Get the full GTBP investor profile, pipeline, and catalyst calendar at USA News Group ?CONTACT:
USA News Group
info @therooster-2873Sources:GT Biopharma, Inc., "GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors," GlobeNewswire, May 14, 2026.GT Biopharma, Inc., "GT Biopharma Reports First Quarter 2026 Financial Results," May 15, 2026 (Cohort 4 complete, 8 patients across first four cohorts; ~$9M cash to Q4 2026; 2H 2026 updates).GT Biopharma, Inc., IND submission / pipeline overview — TriKE mechanism (camelid anti-CD16 / scFv anti-CD33 / IL-15), GTB-3650 dose-escalation design (up to 7 cohorts, ~14 patients), GTB-5550 design and B7-H3 >90% in mCRPC; gtbiopharma.com product pipeline.Roth Capital analyst note (Jonathan Aschoff), price target revised to $3 (Buy), 2026.Global Market Insights Inc. oncology market size ($139.4B 2025 ? $268.3B 2034); Data Bridge Market Research solid-tumor market context.ImmunityBio (NASDAQ: IBRX) Q1 2026 results and NK-cell manufacturing release, 2026.Fate Therapeutics (NASDAQ: FATE) Q1 2026 results (runway into 2028), May 13, 2026.Nkarta (NASDAQ: NKTX) corporate/clinical disclosure, 2026.Artiva Biotherapeutics (NASDAQ: ARTV) corporate disclosure / AlloNK Phase 3 plan, 2026.DISCLAIMER:Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a digital media distribution and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). This article is being distributed by USA News Group on behalf of MIQ. MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Direct Marketing Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this article or email as the basis for any investment decision. The owner/operator of MIQ currently owns shares of GT Biopharma, Inc. that were purchased in the open market and reserves the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company; no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been reviewed and approved on behalf of GT Biopharma, Inc. by CDMG; this is a digital media distribution.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our article is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.Logo: https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg  View original content:https://www.prnewswire.com/news-releases/the-13-million-company-teaching-the-immune-system-to-hunt-cancer-302785505.htmlSOURCE USA News Group Original: The $13 Million Company Teaching the Immune System to Hunt Cancer

NANT Leonardo landed in California and cleared customs! Assembly begins next week of the world's first AI driven cell manufacturing robot. pic.twitter.com/qzHJfC85om— Dr. Pat Soon-Shiong (@DrPatrick) May 26, 2026

The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 26, 2026 in ImmunityBio, Inc. Lawsuit - IBRXMay 26, 2026 9:00 AM
PR Newswire (US) NEW YORK, May 26, 2026 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of ImmunityBio, Inc. (NASDAQ: IBRX). Shareholders who purchased shares of IBRX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/immunitybio-inc-loss-submission-form/?id=186861&from=4CLASS PERIOD: January 19, 2026 to March 24, 2026ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (1) defendant Soon-Shion materially overstated Anktiva's capabilities; and (2) as a result, defendants' statements about ImmunityBio's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.DEADLINE: May 26, 2026 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/immunitybio-inc-loss-submission-form/?id=186861&from=4NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of IBRX during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is May 26, 2026. There is no cost or obligation to you to participate in this case.WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company's stock. Attorney advertising. Prior results do not guarantee similar outcomes.CONTACT:
The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: dg @bback View original content to download multimedia:https://www.prnewswire.com/news-releases/the-gross-law-firm-reminds-shareholders-of-a-lead-plaintiff-deadline-of-may-26-2026-in-immunitybio-inc-lawsuit---ibrx-302779780.htmlSOURCE The Gross Law Firm Original: The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 26, 2026 in ImmunityBio, Inc. Lawsuit - IBRX

$IBRX HUGE Lung Cancer Breakthrough: ANKTIVA Phase 3 Results (34.7 vs 20.2 Months)

ImmunityBio Highlights Patient Survey Data at ISPOR 2026 Showing Majority of UK Adults Living with NMIBC Favor Bladder PreservationMay 22, 2026 7:30 AM
Business Wire UK-based study identifies key patient-centered factors influencing treatment preferences in high-risk NMIBC ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced new survey data highlighting the diverse treatment preferences and decision-making priorities of patients with Bacillus Calmette–Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC). The findings were presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2026, May 17–20, 2026, at the Pennsylvania Convention Center in Philadelphia, Pennsylvania. The mixed-methods study, conducted in partnership with Fight Bladder Cancer, a UK-based patient advocacy organization, explored how patients with NMIBC who were currently receiving or had previously received BCG weigh radical cystectomy against bladder-sparing therapies following BCG treatment failure. The study provides a contemporary, patient-centered perspective on the factors influencing treatment decision-making in this setting. “Treatment decisions for patients with BCG-unresponsive NMIBC are deeply personal and often complex,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These findings reinforce the importance of incorporating patient perspectives, quality-of-life considerations, and individual treatment priorities into shared decision-making conversations.” The study used an online questionnaire completed by 86 UK adults living with NMIBC who were currently receiving or had previously been treated with BCG. This survey data was supplemented by one-on-one interviews and focus group discussions. Together, these methods were designed to evaluate treatment experiences, priorities, and trade-off preferences related to bladder-sparing approaches versus radical cystectomy following BCG failure. The data showed that treatment preferences among UK patients with NMIBC are highly individualized, shaped by past treatment experiences, personal values, and age. Key findings include: Patients actively receiving BCG were more likely to favor bladder preservation strategies Patients who had previously undergone radical cystectomy were more likely to support repeating that decision Older participants demonstrated a lower preference for radical cystectomy Clinical effectiveness, including impact on recurrence, progression, and life expectancy, was identified as the most important factor influencing treatment decisions Lifestyle disruption and quality-of-life considerations varied across patients, with male participants expressing greater concern regarding the daily-life impact of radical cystectomy The authors concluded that UK adults living with NMIBC have widely varying treatment priorities—some placing greater weight on cancer control and life expectancy, while others prioritize quality of life and bladder preservation—with many willing to accept trade-offs, such as more frequent hospital visits, to avoid radical cystectomy. Taken together, the findings underscore that there is no one-size-fits-all approach to treatment decisions in this population, and highlight the importance of individualized, patient-centered care. About Fight Bladder Cancer UK Fight Bladder Cancer is the only patient-led bladder cancer charity in the United Kingdom. The charity is dedicated to supporting people affected by bladder cancer, raising awareness, and funding research to improve diagnosis and treatment. It provides support and mentorship for those impacted by the disease, and creates resources for patients, caregivers, and healthcare professionals. It also advocates for better care and policy change. For more information, visit https://www.fbc.uk.com/ About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding: the potential implications of patient preference data on treatment decision-making and shared care conversations in BCG-unresponsive NMIBC; the potential for bladder-sparing therapies to address unmet needs in patients with high-risk NMIBC; the continued development and commercialization of ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG for BCG-unresponsive NMIBC; the potential for patient-centered evidence to inform healthcare policy, reimbursement decisions, and clinical practice guidelines; future research collaborations and partnerships with patient advocacy organizations; and the potential expansion of indications or patient populations for ImmunityBio's product candidates. These forward-looking statements are based on ImmunityBio's current expectations, estimates, forecasts, and projections and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to: the inherent limitations of survey and qualitative research methodologies; the potential that patient preferences may not translate into clinical practice changes or commercial adoption; risks related to the clinical development, regulatory approval, and commercialization of ANKTIVA, including the ability to demonstrate safety, efficacy, and durability of response; the timing and results of ongoing and future clinical trials; uncertainties regarding regulatory submissions and the ability to obtain and maintain regulatory approvals; manufacturing and supply constraints, including BCG availability; competition from other therapies and treatment approaches; market acceptance and reimbursement of approved products; general economic and market conditions; and other risks described under the heading "Risk Factors" in ImmunityBio's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 7, 2026, and in subsequent filings made with the SEC. ImmunityBio cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. ImmunityBio undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required by applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260522233231/en/ ImmunityBio Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com Media
Sarah Singleton
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com Original: ImmunityBio Highlights Patient Survey Data at ISPOR 2026 Showing Majority of UK Adults Living with NMIBC Favor Bladder Preservation

ImmunityBio Presents Health Economic Analysis at ISPOR 2026 Showing ANKTIVA® Plus BCG Delivers Lower Cost per Sustained Complete Response Versus TAR-200 in BCG-Unresponsive NMIBC CISMay 22, 2026 7:30 AM
Business Wire Analysis demonstrates a lower cost per sustained responder and cystectomy avoided with ANKTIVA plus BCG compared to TAR-200 in Medicare population over three years ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced preliminary results from a new health economic analysis demonstrating that ANKTIVA® (nogapendekin alfa inbakicept-pmln; NAI) plus Bacillus Calmette–Guérin (BCG) achieved a lower cost per sustained complete responder compared to TAR-200 in patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ ± papillary disease (NMIBC CIS). The findings were presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2026, May 17–20, 2026, at the Pennsylvania Convention Center in Philadelphia, by Ruchika Talwar, M.D., Medical Director and Assistant Professor Urologic Oncology at Vanderbilt Health. The authors developed a cost-consequence model comparing ANKTIVA plus BCG, using data from the QUILT-3.032 study, with TAR-200, using data from the SunRISe-1 trial, and evaluated both clinical and economic outcomes in a U.S. Medicare population. A multi-state Markov model incorporating key NMIBC health states and clinical outcomes derived from a matched-adjusted indirect comparison (MAIC) of the two trials was used to assess costs associated with treatment acquisition, administration, healthcare resource utilization, radical cystectomy, and mortality. Key findings include: Cost per cystectomy avoided: ANKTIVA plus BCG demonstrated savings of $109,622 at Year 1, $151,438 at Year 2, and $60,393 at Year 3 compared to TAR-200 Cost per cystectomy-free month: Savings of $9,370 at Year 1, $6,144 at Year 2, and $1,520 at Year 3 Cost per complete responder: Savings of $313,775 at Year 1 and $282,013 at Year 2 Cost reductions were primarily driven by lower drug acquisition and administration costs, based on complete response rates derived from an indirect treatment comparison—49.6% for ANKTIVA plus BCG versus 45.9% for TAR-200. The authors concluded that ANKTIVA plus BCG offers direct cost savings across measurable clinical outcomes for patients with BCG-unresponsive NMIBC CIS compared to TAR-200 in a U.S. Medicare population, with savings persisting across all three years of the analysis. “This health economic analysis reflects our dual mission of developing breakthrough immunotherapies that meaningfully extend lives, while ensuring these innovations are accessible within the broader healthcare landscape. By analyzing the rigorous economic efficiencies of our treatments, we are better positioned to ensure more patients can receive the most innovative and accessible cancer treatments available today,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These results solidify the potential value of ANKTIVA plus BCG in delivering durable responses while reducing costs to the Medicare healthcare system.” “These findings reinforce the importance of aligning clinical innovation with both economic value and patient preferences,” said Ruchika Talwar, M.D., Medical Director and Assistant Professor Urologic Oncology at Vanderbilt Health. “In BCG-unresponsive NMIBC, treatment decisions are not solely about response rates; they are about durability, quality of life, and ensuring patients have access to therapies that are both effective and sustainable within the healthcare system.” About BCG-Unresponsive NMIBC CIS Non-muscle-invasive bladder cancer (NMIBC) represents approximately 75% of all bladder cancer diagnoses in the United States. Patients with carcinoma in situ (CIS) who become unresponsive to BCG therapy face a high risk of recurrence and progression and often have limited bladder-sparing treatment options available. About ANKTIVA® (nogapendekin alfa inbakicept-pmln) The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA® at Anktiva.com. About Fight Bladder Cancer UK Fight Bladder Cancer is the only patient-led bladder cancer charity in the United Kingdom. The charity is dedicated to supporting people affected by bladder cancer, raising awareness, and funding research to improve diagnosis and treatment. It provides support and mentorship for those impacted by the disease, and creates resources for patients, caregivers, and healthcare professionals. It also advocates for better care and policy change. For more information, visit https://www.fbc.uk.com/ About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the potential clinical and economic benefits of ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus BCG for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC); the potential for cost savings and improved healthcare outcomes in Medicare populations; future commercial adoption and reimbursement of ANKTIVA; the continued development and expansion of ImmunityBio's products; and the company's ability to advance its pipeline of immunotherapy candidates and achieve regulatory approvals for additional indications. These forward-looking statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the health economic analysis results may not be predictive of real-world outcomes or may not lead to favorable reimbursement decisions; the risk that ANKTIVA may not achieve commercial success or market acceptance at anticipated levels; risks related to competition from other therapies for NMIBC, including TAR-200 and other investigational treatments; the risk that clinical trials may not demonstrate sufficient efficacy or safety to support additional regulatory approvals; risks related to manufacturing, supply chain, and product quality; uncertainties regarding healthcare reform, pricing pressures, and reimbursement policies; risks associated with intellectual property protection and potential infringement claims; risks associated with product promotion; general economic and market conditions; and other risks described in ImmunityBio's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent quarterly report on Form 10-Q filed on May 7, 2026. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. ImmunityBio undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this release, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260522861965/en/ ImmunityBio Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com Original: ImmunityBio Presents Health Economic Analysis at ISPOR 2026 Showing ANKTIVA® Plus BCG Delivers Lower Cost per Sustained Complete Response Versus TAR-200 in BCG-Unresponsive NMIBC CIS

$IBRX
Breaking at ASCO26: First complete response in recurrent GBM using a chemo-free combo of NAI + PD-L1 t-haNK + bevacizumab. Median OS not reached at 6.75 months. No CRS or ICANS. Major step forward for brain cancer patients.

https://www.asco.org/abstracts-presentations/259222

In bladder cancer patients whose disease returned after BCG, Anktiva + BCG achieved nearly 3x higher complete response rates at 12 months compared to Keytruda (pembrolizumab) — 47% vs 19% - in a matched analysis. Responses also lasted about 10 months longer on average, with a strong safety trend.

https://www.asco.org/abstracts-presentations/263674

https://www.asco.org/annual-meeting/search?contentKey=ANNUAL_MEETING&contentKeyYear=2026&userInput=ImmunityBio

The full, final text of this abstract will be available on May 21 at 05:00 PM ET.

https://www.asco.org/annual-meeting/search?contentKey=ANNUAL_MEETING&contentKeyYear=2026&userInput=ImmunityBio

they saved a life:
Rapid suppression of unresolving disseminated coccidioidomycosis infection with combined IL-15 super-agonist (N-803) and invariant natural killer T cell therapy

Given his protracted clinical course, informed consent was obtained and institutional approval was granted for single patient dosing of N-803 and agenT-797. Emergency use authorization (EUA) was issued on May 13 and he underwent one-time administration of N-803 (IND 177307; May 15; subcutaneous dose of 600 mcg IL-15 superagonist), followed by intravenous agenT-797 (IND 31682; May 17; 1?×?10^9 iNKT cells).

Combination treatment suppressed fungal and bacterial infections
From March 4 to May 15, the patient was treated for unresolving pneumonia, ultimately diagnosed as C. immitis, recurrent heart failure due to dynamic mitral value dysfunction and severe ARDS. He also had superimposed healthcare-associated Pseudomonas pneumonia and AKI/CKD, and was started on meropenem following second intubation on MAY 7. Following treatment with N-803 and agenT-797, fungal respiratory cultures became negative for C. immitis and the pseudomonal burden in BAL declined from >100,000 colony forming units (CFU) on May 11 (four days before treatment) to rare growth (20-fold rise in BAL immune cell infiltration was also noted (71 nucleated cells/µL, May 15 (D1) to 1501 cells/µL, May 21 (D7); Figure 1E). Post-treatment BAL cytokine dynamics demonstrated rapid local reduction in early-phase IL-1 family inflammation pathways (Figure 1F) and increases in factors driving recruitment and activation of cell-mediated immunity, including of T and NK cells (IFN-?, IP-10), Eosinophils (IL-8, Eotaxin), and alveolar macrophages (GM-CSF, IL-6, VEGF-D; Figure 1G). Factors associated with stem cell recruitment (SCF, SDF-1a), M2 macrophages (IL-10, VEGF-D), and dampening of inflammation (IL-10) also increased following treatment indicating activation of tissue repair mechanisms (Figure 1H). These findings demonstrate that N-803 plus agenT-797 can restore local immunity and control persistent infections despite systemic immunosuppression.


https://www.sciencedirect.com/science/article/pii/S2772613426000120

the calm before the storm.....

new updates tomorrow

Tomorrow, May 21st at 5 PM Eastern. That’s when the full abstracts for these regular ones drop on the ASCO site. So what does IBRX have?

Quilt 2.023 https://t.co/hqnuFcl2V1
- halted phase 3 first line treatment

ResQ 201A https://t.co/zAz3d7cHLO
New phase 3 second line plus…— Harpoon Harry (@oshea9_harry) May 21, 2026

HUGE- Anktiva teamed up with special immune booster cells (from MiNK) and helped a very sick patient beat tough lung infections (Valley Fever + bacteria). It woke up the immune system, cleared germs, calmed inflammation, and started lung repair, even after other treatments failed

The patient was critically ill, facing a convergence of severe threats: disseminated Coccidioides immitis (valley fever) fungal infection, severe acute respiratory distress syndrome (ARDS), and concurrent hospital-acquired Pseudomonas aeruginosa bacterial pneumonia, all after standard-of-care antifungal, antibacterial, and supportive therapies had failed to halt clinical decline.

Key Clinical and Translational Findings

Following sequential treatment with Anktiva (N-803) and agenT-797, investigators observed:

Suppression of both fungal and bacterial pathogens
Active immune cell recruitment into the lung
Reduced early inflammatory signaling
Activation of tissue repair and immune regulatory pathways

https://investor.minktherapeutics.com/news-releases/news-release-details/mink-therapeutics-reports-new-data-agent-797-allo-inkt-cell

$IBRX
$INKT

How do you explain today's move?
A good start, on excellent news, and a close almost at par.
Are they keeping it low to accumulate?

Thanks.

ANKTIVA's unique IL-15 mechanism boosts lymphocyte proliferation, showing strong efficacy in solid cancers with lymphopenia and outperforming prior immunotherapies.

the next one- pancreatic cancer!!!!!!!!

Strong QUILT-3.032 papillary data + dire unmet need justify Priority Review. The FDA may shorten the decision to July 2026.

$IBRX must read!
Imagine you love someone with high-grade papillary bladder cancer that came back after BCG. They were told the next step was to take out the bladder. They went looking for anything else they could try. Last week they came across a drug, ANKTIVA, that the FDA approved in 2024 for the closely related form of the same disease, but not yet for theirs. They asked their urologist whether it could be used. The urologist said they were waiting to see what the FDA was going to do.

This Tuesday, the FDA answered.

WHAT THE LETTER SAID

On May 19, 2026, the FDA accepted ImmunityBio's supplemental Biologics License Application for ANKTIVA in combination with BCG, for BCG-unresponsive high-grade papillary-only non-muscle-invasive bladder cancer.

The action date the FDA committed to, the day by which it will issue its final decision, is January 6, 2027.

THE SIXTY DAYS THAT BECAME SEVENTY-ONE

The same application was turned away last year. The FDA refused to file it.

The company met with the FDA in January 2026 and was told what additional information was needed. No new clinical trials. A written submission detailing the overlapping features of papillary disease and CIS. The company submitted it. On March 9, 2026 the FDA acknowledged receipt, and the formal sixty-day filing-review clock started.

Sixty days from March 9 is May 8.

May 8 came and went. So did May 9, 10, 11, 12, 13, 14, 15.

On Saturday, May 16, at the American Urological Association Annual Meeting, the company's founder stood on a stage and said, into a microphone: "The 60 days have passed. We've not heard anything from the FDA. We're awaiting some response. I'm hopeful."

Three days later, on Tuesday, the response came.

Seventy-one days from receipt. Eleven days past the formal window. And then accepted.

ACCEPTED IS NOT APPROVED

Accepted means the FDA looked at the resubmitted application, decided it was complete enough to review on the merits, and started the formal clock. The decision comes in January 2027.

Between now and then the FDA reviews the application, may ask further questions, may convene advisory panels, may extend its own timeline. None of that has happened yet. This week, only one thing happened. The door opened.

But the door opening matters.

THE PAPER ANYONE CAN READ

The trial behind this application is QUILT-3.032 (NCT03022825). Its papillary-only cohort, Cohort B, was published in the Journal of Urology in January 2026, peer-reviewed and Open Access. The lead author is Sam S. Chang at Vanderbilt.

That is unusual for a binary regulatory event. Most of the time, the data on the FDA's desk is summarized through press releases and conference slides while the peer-reviewed publication lags by months or years. Here, the peer-reviewed publication landed first. The FDA is reading the same paper a patient's spouse can read tonight.

The link: https://auajournals.org/doi/10.1097/JU.0000000000004782.

From the paper, with a data cutoff of July 15, 2024:

- Disease-free survival at 12 months: 58.2% (95% CI 46.6, 68.2)

- DFS at 24 months: 52.1% (CI 40.3, 62.7)

- DFS at 36 months: 38.2% (CI 25.6, 50.6)

- Progression-free survival at 12 months: 94.9% (CI 86.9, 98.0)

- PFS at 36 months: 83.1% (CI 69.5, 91.0)

- Disease-specific survival at 12 months: 98.7% (CI 91.4, 99.8)

- DSS at 36 months: 96.0% (CI 88.2, 98.7); median not reached

- Cystectomy avoidance at 12 months: 92.2% (CI 83.4, 96.4)

- Cystectomy avoidance at 36 months: 81.8% (CI 68.1, 90.1); median time to cystectomy not reached

- Treatment-related adverse events: 61% Grade 1 to 2; 3% Grade 3; no Grade 4 or 5

In plain English. Disease-free survival measures whether the cancer comes back at all, including in non-aggressive forms. About six in ten patients had no return of any kind at one year. By three years that has fallen to roughly four in ten, which sounds modest. The next three lines are the ones that change a patient's life.

Progression-free survival measures whether the cancer becomes muscle-invasive, the stage at which the bladder has to be removed or the disease becomes lethal. At one year, nineteen out of twenty patients had kept the cancer in the bladder lining, where it was still treatable. At three years, that was true for more than four out of five.

Disease-specific survival measures whether the bladder cancer kills you. At three years, ninety-six out of a hundred patients were still alive from this disease. The median, the point at which half the patients have died, has not been reached. The statisticians cannot yet draw the line.

And cystectomy avoidance, the line that means the patient still has a bladder: more than four out of five at three years. The median time to cystectomy, the point at which half had needed the operation, has not been reached either. They still have their bladders.

These are not press-release marketing numbers. They are the numbers in a peer-reviewed paper, downloadable as a PDF, sitting under a DOI.

The patients were told to lose their bladders.

Most still have them.

WHAT THE FDA WROTE ABOUT THE REVIEW

The FDA did not just accept the application. The acceptance letter, summarized in the company's press release on Tuesday, said two things.

The first set the review focus. The company quoted the FDA verbatim:

"The scientific data detailing these overlapping features will be the focus of the review of this sBLA to determine if there is adequate justification to allow for such an extrapolation and expansion of the indication of Anktiva with BCG to include the treatment of patients with BCG-unresponsive NMIBC with papillary tumors."

The FDA committed to spend the months between now and January 6 on the exact question the workshop spent Monday answering.

The second the company described in its own narrative prose, attached to the first by the word "while." Per the press release, the FDA reiterated its concerns relating to single-arm trials in papillary disease alone (Cohort B), given that the initial indication for CIS and papillary disease (Cohort A) has already been approved on a single-arm trial.

That second statement, even in the company's paraphrase, is the most interesting thing about the letter.

The concern, as reported, is that Cohort B was a single-arm trial. Patients received ANKTIVA plus BCG; their outcomes are reported; there is no randomized control arm receiving a different therapy for comparison. The FDA has historically preferred randomized controlled trials.

But the FDA approved Cohort A, CIS with or without papillary disease, from the same QUILT-3.032 trial, on the basis of a single-arm result in April 2024.

The exact methodology the FDA is reported to be reiterating concerns about is the methodology the FDA itself accepted as adequate two years ago, for the closely adjacent indication, in this same disease.

The review will turn on whether what was acceptable for one face of the disease is acceptable for the other.

WHAT THE FDA HAS ALREADY APPROVED

The FDA has approved five drugs for BCG-unresponsive non-muscle-invasive bladder cancer in the last twenty-seven years. All five were approved on single-arm trials.

- Valrubicin, 1998. Single-arm Phase 2 in 90 patients.

- Pembrolizumab, January 2020. KEYNOTE-057, single-arm Phase 2 in 96 evaluable patients. The advisory committee voted nine to four in favor.

- Nadofaragene firadenovec, December 2022. Single-arm in 98 evaluable patients.

- ANKTIVA's Cohort A, April 2024. The same QUILT-3.032 single-arm design, 77 patients.

- TAR-200, 2025. SunRISe-1 Cohort 2, single-arm Phase 2b in 85 patients.

In 2018, the FDA published its own guidance on developing drugs for BCG-unresponsive NMIBC. The guidance states, in writing, that a single-arm trial design is appropriate in this disease for patients with no standard therapy other than cystectomy. The FDA wrote the rule. The FDA then approved five drugs under it.

There is precedent outside this disease as well. In May 2017, the FDA granted the first-ever tissue-agnostic cancer approval to Merck's Keytruda (pembrolizumab) on the basis of 149 patients across five single-arm trials covering fifteen tumor types.

ANKTIVA's Cohort B sBLA uses the same single-arm methodology, in a population the FDA's own letter describes as having overlapping clinical and non-clinical profile with the indication already approved. Eighty patients. Three years of published peer-reviewed follow-up.

WHAT HAPPENED MONDAY

The day before the acceptance, on Monday May 18, the FDA's Oncology Center of Excellence convened a public workshop on non-muscle-invasive bladder cancer.

The first panel asked, on the record, whether CIS and papillary disease are the same disease.

The panel concluded they probably are. Different anatomical presentations of one biological process. A urologist on the panel testified that about one in twenty US urologists routinely use blue-light cystoscopy, which means CIS is missed at the initial diagnosis in most cases when it is there. Several panelists testified that when they treat high-grade papillary disease, they treat it the same way regardless of whether CIS is found alongside it. Because the FDA has not yet approved any therapy specifically for papillary-only BCG-unresponsive disease, urologists routinely use therapies labeled for CIS off-label in this setting, because what else is there.

ImmunityBio's own acceptance press release the next day restated the workshop conclusion in nearly the same language: that CIS and papillary disease "arise from the same cancer inducing clone, is therefore the same disease." The company's submission, the panelists' testimony, and the FDA's filing letter about "overlapping features" of the two presentations all converge on the same sentence.

That is the answer to the exact question the FDA's review will turn on.

It was on the record at the FDA the day before the FDA accepted the file.

The workshop happened on Monday.

The letter went out on Tuesday.

The timing is not a coincidence and was never supposed to be.

WHAT WAS ALREADY IN PLACE

While the application sat at the FDA, several other pieces had been locking into place around it.

The National Comprehensive Cancer Network added ANKTIVA plus BCG for BCG-unresponsive papillary-only NMIBC to its bladder cancer Clinical Practice Guideline as a Category 2A recommendation in March 2026. The NCCN's Drugs and Biologics Compendium, the publication that the Centers for Medicare and Medicaid Services consults under §1861(t)(2)(B)(ii)(I) of the Social Security Act, tracks the Guideline. The statutory pathway to Medicare coverage for off-label use was already open before the FDA accepted the file.

The United Kingdom's Medicines and Healthcare products Regulatory Agency approved ANKTIVA plus BCG for BCG-unresponsive CIS in July 2025. The European Medicines Agency followed in February 2026. International regulators had already decided the data was strong enough for the closely related indication.

On Monday, the day of the workshop, ImmunityBio also disclosed a US patent estate of five issued and one pending patent, with coverage extending through 2035, written to apply to any FDA-approved BCG strain rather than to a single supplier. The same day, a separate SEC 8-K disclosed an exclusive ten-year US supply agreement for the Japanese BCG-Tokyo-172 strain, structured with no payment due to the supplier until FDA approval of the combination. The US BCG supply has been served by a single FDA-approved strain, rationed since 2019; adding a second strain matters.

None of those pieces are the trial data. None of them substitute for FDA approval. But all of them are the pieces you would put in place if you were preparing for the moment a regulator opened the door.

WHAT JANUARY 6 MEANS

It does not mean approval. It means the day by which the FDA has committed to issue its decision, and the decision can be one of several: approve, approve with restrictions, issue a Complete Response Letter requiring further work, extend the timeline. The decision lands on or before that day.

It also does not mean a fast decision. From the FDA's receipt of the application on March 9 to the action date on January 6 is about ten months, the Standard Review goal for an efficacy supplement. Priority Review would have been six. The FDA, by the calendar, did not expedite.

For the patient whose spouse read about ANKTIVA last week, whose disease is high-grade papillary-only and whose next medical step is removal of the bladder, January 6 is not the end of the wait. It is the new shape of the wait. There is now a calendar date, set by the FDA itself, by which the FDA has committed to answer.

There was no such date on Monday.

There is one now.

THE LETTER

The letter came on Tuesday.

The patients in the paper were told to lose their bladders. Most still have them.

January 6 is the day the FDA decides who else gets to keep theirs.

https://x.com/ActionFixesFear/status/2056971079504306571

PDUFA Date Set for January 6, 2027.

A major regulatory milestone and an important step toward expanding treatment options for patients with papillary NMIBC. Now the focus shifts to approval.

$IBRX

ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027May 19, 2026 8:30 PM
Business Wire Supplemental BLA seeks to expand the ANKTIVA label to include patients with BCG-unresponsive NMIBC with papillary disease FDA noted in its filing communication that the supplemental BLA accepted for review was based on the additional scientific data ImmunityBio provided at the Agency’s request, detailing the overlapping features of papillary and CIS disease to determine adequate justification to allow for the expansion of the already approved indication of ANKTIVA with BCG to include the treatment of patients with BCG unresponsive NMIBC with papillary tumors During the FDA workshop held on May 18, 2026, panelists stated that CIS and papillary disease arise from the same cancer inducing clone, is therefore the same disease biologically, and that the clinical treatment decision made by the panelists when papillary disease alone is identified, is to treat the patient off-label with an already FDA approved therapy for CIS and papillary disease This analysis of the experts at the FDA workshop was consistent with the recent decision (March 2026) by the NCCN panel of experts to designate the treatment of BCG-unresponsive non-muscle invasive bladder cancer papillary disease as a Category 2A guideline for practicing urologists treating such patients with papillary disease alone. FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of January 6, 2027 Approximately 85% of the 64,000 people diagnosed with NMIBC in the U.S. each year present with papillary disease1 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA assigned a PDUFA target action date of January 6, 2027. In the filing communication, the FDA stated, “In support of this expansion, you have submitted the results of QUILT-3.032 Cohort B and a literature-based rationale proposing that papillary NMIBC has an overlapping clinical and non-clinical profile with CIS that may allow for extrapolation of results from patients with CIS, as was demonstrated in QUILT-3.032 Cohort A, the basis of the existing indication, to those with papillary-only disease.” The Agency further provided insight as to the focus of the review of this sBLA by stating, “The scientific data detailing these overlapping features will be the focus of the review of this sBLA to determine if there is adequate justification to allow for such an extrapolation and expansion of the indication of Anktiva with BCG to include the treatment of patients with BCG-unresponsive NMIBC with papillary tumors,” while reiterating their concerns relating to single-arm trials in papillary disease alone (Cohort B) in which the initial indication for CIS and papillary disease (Cohort A) has already been approved in a single-arm trial. If approved, the sBLA would expand the current indication for ANKTIVA plus BCG and further broaden treatment options for patients with BCG-unresponsive NMIBC. Recently the FDA convened a public workshop on May 18, 2026 titled, “Contemporary Issues in Non-Muscle Invasive Bladder Cancer (NMIBC) Trial Design and Interpretation,” which addresses the issues to be reviewed in this sBLA and included discussion among clinicians, scientific experts and thought leaders regarding the biological similarities of CIS and papillary and the treatment decisions for patients with papillary disease alone. The meeting was available to the public in real-time. At the workshop, panelists stated that CIS and papillary disease arise from the same cancer inducing clone, is therefore the same disease and the clinical decision treatment made when papillary disease alone is identified in the real-world is to treat the patient with already FDA approved therapies for CIS and papillary disease. These statements made by the expert panel at the FDA workshop on May 18, 2026, are consistent with the decision of the NCCN panel of experts to designate on March 2026, the treatment of BCG unresponsive non-muscle invasive bladder cancer papillary disease as a Category 2A guideline for practicing urologists treating such patients with papillary disease alone. The FDA workshop meeting goals included the issues directly pertinent to sBLA submission currently under review and, as the Agency stated, the focus of the sBLA review as follows: “Discuss the similarities and differences between the two types of histology (papillary and CIS) observed in NMIBC and implications for the demonstration of efficacy in clinical trials.” “Patients with BCG-unresponsive NMIBC with papillary disease are faced with the option of a total radical cystectomy and continue to face limited treatment options with no FDA approved therapy to date that strives to preserve the bladder, while reducing the risk of disease progression to muscle-invasive cancer,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The FDA’s acceptance of this supplemental application for review represents an important step toward potentially expanding access to ANKTIVA plus BCG for patients with high-grade BCG unresponsive NMIBC. We were encouraged by the scientific discussion at the recent FDA workshop regarding the biological overlap between CIS and papillary disease and the current real-world treatment approaches for these patients. We look forward to continuing to work with the Agency during its review of the application.” Dr. Soon-Shiong who attended the FDA workshop, further stated, “The feedback from the thought leaders at the FDA workshop meeting relating to the real-world clinical treatment of patients with papillary disease alone was significantly important in informing the Agency of the clinical and scientific views of clinicians treating patients with high-grade non-muscle invasive bladder cancer. Of significance was the statements by the panelists at the FDA workshop, that when patients with this indication of papillary disease alone are identified, the conclusion was that CIS may indeed exist but not identified and furthermore the identification of CIS was irrelevant in their treatment decisions. The panelists stated that in this instance, the treatment for these patients in the real-world was to offer therapies that are already approved by the FDA for BCG unresponsive NMIBC with CIS and papillary disease, emphasizing the real-world need for an approved therapy for patients with papillary disease alone. I was grateful for these insights and the consistency of these statements with the recent designation by the expert panel at NCCN to provide Category 2A inclusion as part of the guidelines for practicing physicians managing patients with BCG unresponsive NMIBC papillary disease alone,” he said. The supplemental application is supported by data from the QUILT 3.032 Phase 2/3 trial (Cohort B; NCT03022825) in 80 patients with high-grade papillary-only NMIBC. As published in The Journal of Urology (Chang et al., 2025), the study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2% (95% confidence interval: 46.6-68.2%). The ultimate clinical goal of the treatment of patients with high-risk non-muscle invasive bladder cancer is to avoid or delay a life-changing total radical cystectomy, which is fraught with high morbidity and mortality rates, and to prevent progression of the disease from non-muscle invasive to muscle-invasive and metastasis. The secondary endpoints of the chemo-free immunotherapy based treatment of ANKTIVA plus BCG in Cohort B that identifies the results addressing this goal of delaying progression into muscle-invasiveness and accomplishing bladder sparing are: Progression Free Survival (PFS) Cystectomy Free Survival Disease Specific Survival (DSS) The data submitted to the Agency regarding these secondary endpoints for consideration and published in peer reviewed journals (New England Journal of Medicine and Journal of Urology), as well as accepted by NCCN with a Category 2A designation for patients treated with intravesical ANKTIVA plus BCG with BCG unresponsive non-muscle invasive bladder cancer and papillary disease alone demonstrated: Progression-Free Survival (PFS): 94.9% at 12 months and 82.0% at 36 months, indicating durable prevention of progression to muscle-invasive disease. Cystectomy Free Survival: Bladder preservation remained high, with cystectomy-free survival of 92.2% at 12 months and 83.1% at 36 months, meaning over 80% of patients avoided radical cystectomy through three years of follow-up. Disease-Specific Survival (DSS): 96.0% Disease-Specific Survival (DSS) rate at 36 months, with median DSS not yet reached at time of submission of the sBLA. The safety data submitted in this supplemental BLA was consistent with the safety data of the indication already approved, demonstrating qualitatively that the serious adverse events of ANKTIVA when combined with BCG was consistent with that of BCG alone. ANKTIVA plus BCG was previously approved by the FDA in April 2024 for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. Non-muscle-invasive bladder cancer (NMIBC) represents approximately 80% of all bladder cancer diagnoses in the United States, approximately 85% of people diagnosed with NMIBC in the U.S. each year present with papillary disease. Patients with papillary disease who become unresponsive to BCG therapy face a high risk of recurrence and progression and often have limited bladder-sparing treatment options available. "Today's acceptance of the supplemental BLA represents an important milestone for ImmunityBio and for patients with BCG-unresponsive NMIBC,” said Richard Adcock, President and CEO of ImmunityBio. “ANKTIVA is already approved for patients with CIS with or without papillary disease, and this application has the potential to expand access to patients with papillary-only disease, the larger segment of the BCG-unresponsive population. The revelation by the clinicians at the FDA workshop that they treat patients today with papillary disease alone by offering off-label FDA approved therapies for papillary and CIS disease, emphasizes the urgent need for this therapy to be made available to patients suffering from high-grade NMIBC. If approved, this expanded indication would further position ANKTIVA plus BCG as an important immunotherapy option across the NMIBC treatment landscape, enabling insurance reimbursement, making this chemotherapy free treatment available to more patients.” About ANKTIVA® (nogapendekin alfa inbakicept-pmln) The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA® at Anktiva.com. About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. https://pmc.ncbi.nlm.nih.gov/articles/PMC3263923/ Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding: the potential timing and outcome of the FDA's review of the supplemental Biologics License Application (sBLA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease, including the PDUFA target action date of January 6, 2027; the potential for FDA approval of the sBLA and the expansion of the ANKTIVA label to include patients with BCG-unresponsive NMIBC with papillary disease; the potential commercial impact and market opportunity of such an expanded indication; the ability of ANKTIVA plus BCG to provide durable, bladder-sparing treatment options for patients with BCG-unresponsive NMIBC; and the Company's expectations regarding the role of ANKTIVA as a foundational IL-15 immunotherapy for NMIBC. These forward-looking statements are based on management's current expectations, estimates, forecasts, and projections as of the date of this release and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. Factors that could cause actual results to differ include, but are not limited to: the risk that the FDA may not approve the sBLA on the anticipated timeline or at all; the risk that the FDA may require additional clinical data or impose other conditions that delay or prevent approval; uncertainties regarding the FDA's evaluation of the scientific data supporting extrapolation between papillary and CIS disease; risks related to the Company's ability to successfully commercialize ANKTIVA for an expanded indication, including market acceptance, reimbursement, and competition; risks associated with manufacturing and supply chain; the potential for safety or efficacy concerns to arise; general economic and market conditions; and other risks described in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed on February 23, 2026, and its Quarterly Report on Form 10-Q filed on May 7, 2026, as well as current reports on Form 8-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. ImmunityBio undertakes no obligation to update any forward-looking statement to reflect new information, future events, or circumstances, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260519760562/en/ ImmunityBio Contacts: Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com Original: ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027

A Biologics License Application (BLA) is a formal request to the U.S. Food and Drug Administration (FDA) for permission to commercially market a biological product across state lines. This includes products like vaccines, gene therapies, and monoclonal antibodies.

ImmunityBio: Looking Beyond Bladder Cancer To A Multibillion-Dollar Solid Tumor TAM
May 19, 2026, 10:04 AM ETImmunityBio, Inc. (IBRX) Stock

Emanuel Nemec

ImmunityBio, Inc. receives a Strong Buy rating, driven by ANKTIVA's compelling clinical data and major regulatory catalysts ahead.
ANKTIVA's unique IL-15 mechanism boosts lymphocyte proliferation, showing strong efficacy in solid cancers with lymphopenia and outperforming prior immunotherapies.
QUILT trial results validate lymphocyte count as a survival biomarker, supporting likely BLA approval and unlocking broad oncology opportunities.
IBRX stock trades on future expectations; cash burn and potential dilution present risks, but dollar cost averaging is recommended for long-term positioning.
A scientific research team collaborating in a modern laboratory, conducting experiments, analyzing samples, and using advanced lab equipment



This is my first coverage of ImmunityBio, Inc. (IBRX). In this article I will analyze their clinical trial results and the immunology behind them. Using this data, I will analyze the potential future opportunities and regulatory catalysts serving as a basis for continued stock price appreciation, and try to justify my Strong Buy rating. Note that I will not analyze the bladder cancer indication, as I believe that it is fully priced in and is currently the main driver of revenues.

Introduction
ImmunityBio is a biotech company whose lead asset ANKTIVA (nogapendekin alfa inbakicept-pmln), is designed to stimulate T and natural killer cells to proliferate. ANKTIVA is a specially engineered interleukin-15 agonist. It utilizes the IL-15 pathway and, thus, does not trigger immunosuppressive regulatory T cells, unlike drugs utilizing IL-2, which was the exact mechanism causing many immunotherapies to fail in the past. Without triggering T regulatory cells, it is able to treat a condition known as lymphopenia and/or to stimulate the proliferation of specifically engineered CAR-NK cells, which the company co-administered in certain solid cancers. Thus, it simultaneously stimulates the patient's native immune cells and specifically these off-the-shelf CAR-NK cells. These cells are designed to detect PD-L1 antigens on cancer cells, and cause their lysis. Now that we roughly understand the biology, let’s look at the current status of the drug, and the trial results.

QUILT 88 Cohort C Data
This lymphocyte proliferation mechanism was validated and presented at the ASCO 2025 Annual Meeting using the data from Cohort C of the Quilt-88 trial. In this cohort participants with 2nd line or greater locally advanced or metastatic pancreatic cancer received ANKTIVA and PD-L1-targeted high-affinity natural killer cell therapy in combination with low-dose chemotherapy as a = 3rd line therapy. The company conducted internal comparisons and compared overall survival between responders who achieved an absolute lymphocyte count greater than 1.045 x 10 ^9 cells/L (median OS: 7.1 months) and non-responders who had lower lymphocyte counts (median OS: 3.1 months). This is in my opinion quite significant, and clearly demonstrates the ability of the infused CAR-NK cells to target PD-L1 expressing tumor cells, while ANKTIVA restores the absolute lymphocyte count and provides the IL-15 signals needed to proliferate these engineered CAR-NK cells.

The QUILT-2.023 and QUILT-3.055 Trials
Besides the Cohort C data, ImmunityBio also presented additional positive results from QUILT trials at the start of 2026. These trials were designed to test the hypothesis that disease recurrence after checkpoint therapy reflects immune exhaustion and lymphocyte depletion, and that restoration of immune competence through activation of natural killer cells and CD8 cytotoxic T cells with ANKTIVA, in combination with checkpoint inhibitors, could improve outcomes. The QUILT-3.055 trial was successful as it established ANKTIVA’s contribution as a lymphocyte-stimulating agent and that patients treated with ANKTIVA plus a checkpoint inhibitor experienced significantly longer overall survival compared with non-responders (median OS 16.2 vs 11.8 months).

Expanded Access Authorization and Potential BLA Approval
These studies were the reason the FDA granted ImmunityBio expanded access authorization in June 2025. Note that the finalized results from the QUILT trials came after the initial expanded access authorization.

This leads us to the strongest catalyst that is, I believe, likely to happen in the future: the full BLA approval. Instead of using a genetic mutation as the biomarker, ImmunityBio is using the absolute lymphocyte count as a marker to correlate with overall survival. The FDA has essentially agreed on it, as evidenced by the expanded access authorization being granted for this exact biomarker. In the aforementioned trials, they provided evidence that lymphocyte count correlated with overall survival. I believe it is highly likely that they will be able to demonstrate it again and get ANKTIVA approved for lymphopenia in solid cancers. Note that lymphopenia is quite common, and if they manage to get it approved, they will unlock an enormous opportunity across different cancers where lymphopenia is present.

In my opinion, this is the single largest catalyst for the next year or two. An investor can buy a starter position now, or wait until the company submits a BLA application and potentially get the stock for a lower price due to some investors locking in profits in the near future. Yet the opposite can also happen; if the company provides highly positive data, the stock could continue to rise.

Q1 2026 Earnings Results and Valuation
Even though I believe the company’s future and valuation depend on the BLA approval for lymphopenia, I would still like to review the latest earnings report and provide my opinion on it. In Q1 2026, ImmunityBio reported net product revenue of $44.2 million and an operating income of negative $69.8 million. With a market cap of approx. $8.3 billion, we can quickly notice that it is trading on future expectations and not current earnings. Thus, I believe it would be futile to do any kind of valuation analysis, as we would quickly come to the conclusion that the stock is overvalued.

On the balance sheet, ImmunityBio reported $380 million in cash & cash equivalents. Based on the current TTM cash burn of approx. $125 million, we can conclude they would most likely need to raise further cash before the potential BLA approval, especially since large scale trials can be quite expensive. Should the company choose to do an ATM offering, it would likely cause the stock price to drop and provide a long-term investor an opportunity to open a position.

Risks
The main risk is failure to secure the BLA approval. If this were to happen the company would immediately re-rate significantly lower. But I believe the chances are low, as ImmunityBio demonstrated ANKTIVA’s efficacy numerous times, through the past trials. Additionally, the drug is already widely approved for treating bladder cancer, which can serve as a stepping stone.

The second risk is that the company might have to raise significant funds to secure the BLA approval, and expand commercial manufacturing. If this were to coincide with a recession due to the rising inflation, and the company chooses to do an ATM offering, the demand for the stock could turn out to be low, and the stock price would fall further than expected. Perhaps the best way to mitigate this risk is dollar cost averaging.

Plan
I believe the opportunity for the company is immense, if they manage to secure the BLA approval. Since I believe this is likely, I am initiating IBRX with a Strong Buy rating with the aim to slowly scale into a full position by dollar cost averaging.

This article was written by


Emanuel Nemec
661 Followers
I first entered investing in 2016 as an individual value investor. In 2022, I established the investment firm Libra Capital. I mostly write articles as part of my deep research into a company before I make an investment

ImmunityBio just dropped standout comparative data at AUA2026: NAI + BCG ( ANKTIVA) crushes the competition - patients twice as likely to achieve complete response vs nadofaragene, with more than double the median duration of response (22.1 vs 9.7 months) and 60% lower cystectomy risk. Plus better safety profile vs TAR-200.

The real win here is tolerability Against TAR-200, ANKTIVA showed comparable response rates but significantly fewer side effects — 61.7% versus 83.5% adverse event rate.

$IBRX winner

ImmunityBio Presents Favorable Comparative Effectiveness Data in Complete Response Rates of NAI + BCG Versus Nadofaragene and TAR-200 at AUA 2026May 19, 2026 7:30 AM
Business Wire NAI+BCG versus Nadofaragene Results: NAI+BCG treated patients were twice as likely to achieve a complete response (CR) at any point of the study versus nadofaragene firadenovec-vncg in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary disease Median duration of CR with NAI+BCG was more than twice that observed with nadofaragene firadenovec-vncg (22.1 versus 9.7 months) NAI+BCG reduced cystectomy risk by 60% versus nadofaragene NAI+BCG versus TAR-200 Results: NAI+BCG demonstrated numerically higher 12-month CR rates and fewer treatment-related adverse events of any grade than TAR-200 (61.7% versus 83.5%) ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage immunotherapy company, today announced results from two indirect treatment comparison (ITC) analyses presented at the 2026 American Urological Association (AUA) Annual Meeting evaluating nogapendekin alfa inbakicept-pmln (NAI, ANKTIVA®) plus Bacillus Calmette–Guérin (BCG) against two other U.S. Food and Drug Administration (FDA) approved therapies for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease. The AUA 2026 ITC presentations were: Podium presentation - PD25-15 (Edwards et al.): NAI+BCG versus nadofaragene firadenovec-vncg in BCG-unresponsive NMIBC CIS with or without papillary disease Interactive poster - IP50-12 (Jayram et al.): NAI+BCG versus TAR-200 in BCG-unresponsive NMIBC CIS with or without papillary disease Comparative Effectiveness Versus Nadofaragene Firadenovec-vncg In the absence of head-to-head randomized trials, ImmunityBio conducted a matching-adjusted indirect comparison (MAIC) using individual patient data from QUILT-3.032 (Cohort A, NAI+BCG, n=100) weighted against aggregate data from NCT02773849 (CIS Cohort, nadofaragene firadenovec-vncg, n=103). Baseline matching variables included age (≥65 years), sex, Eastern Cooperative Oncology Group (ECOG) performance status, race, and tumor stage. Effective sample sizes after weighting ranged from 71.7% to 84.2% across endpoints. After matching, NAI+BCG demonstrated: Anytime CR rate of 69.7% (weighted) versus 53.4% for nadofaragene firadenovec-vncg; OR 2.01 (95% CI: 1.08, 3.72); E-value 3.43 Median duration of complete response of 22.1 months versus 9.7 months, a difference of 12.45 months (95% CI: 8.17, 17.09); HR for end of response 0.57 (95% CI: 0.34, 0.95) Cystectomy-free survival HR 0.40 (95% CI: 0.21, 0.75) Overall survival HR 0.85 (95% CI: 0.22, 3.31), not statistically different between treatments Kaplan-Meier curves for duration of response and cystectomy-free survival remained consistently above the nadofaragene firadenovec-vncg comparator throughout the follow-up period. Sensitivity analyses using simulated treatment comparison (STC) methodology produced consistent results. “The magnitude and durability of complete response observed with NAI+BCG, combined with a meaningful reduction in the risk of cystectomy, are clinically relevant for patients with BCG-unresponsive NMIBC for whom bladder preservation is the priority,” said Dr. Brooke B. Edwards, the Urology Group, Cincinnati, OH. “These comparative data, while subject to the inherent limitations of unanchored indirect comparisons, provide context that can support shared decision making with patients considering bladder-sparing therapy.” Comparative Effectiveness Versus TAR-200 A separate MAIC was conducted comparing individual patient data from QUILT-3.032 (Cohort A, NAI+BCG, n=100) with aggregate data from SunRISe-1 (Cohort 2, TAR-200, n=85). Matching variables included age, sex, ECOG performance status, race, prior BCG instillations, and tumor stage. Outcomes of interest were complete response rate at 12 months and treatment-related adverse events of any grade. Key findings from the base-case adjusted MAIC: At 12 months, NAI+BCG achieved a higher complete response rate than TAR-200 (49.2% versus 45.9%; OR 1.14; 95% CI: 0.61, 2.15); the difference did not reach statistical significance Patients treated with NAI+BCG experienced substantially fewer treatment-related adverse events of any grade than patients treated with TAR-200 (61.7% versus 83.5%), a statistically significant 68% reduction in adverse event odds (OR 0.32; 95% CI: 0.15, 0.67); E-value 5.70 Sensitivity analyses using both MAIC and STC methodologies produced consistent safety findings, with E-values exceeding 5 across analyses, indicating that any unmeasured confounder capable of negating the safety finding would need to be approximately 5 times stronger than the measured baseline risk factors "The comparative effectiveness data presented at AUA 2026 reinforce what we have observed across the ANKTIVA development program: that IL-15, working through the trifecta of NK cells, CD8+ T cells, and memory T cells, can produce complete responses that are not only more frequent but materially more durable than other approved therapies for BCG-unresponsive non-muscle invasive bladder cancer," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "A duration of complete response more than twice as long as with nadofaragene speaks directly to the central question patients ask: ‘how long will my response last?' These ITC analyses, while subject to the limitations of unanchored comparisons, add to the growing body of evidence that ANKTIVA plus BCG can serve as the immunological backbone of bladder cancer treatments. Beyond the data, the enthusiasm we heard directly from urologists at AUA about our continued advancement of recombinant BCG, and our parallel progress in developing an additional source of conventional BCG with the Tokyo strain, was a welcome confirmation that the field shares our urgency. It is exciting to be in a position to offer urologists and their patients additional sources of intravesical immunotherapy at a moment when the persistent U.S. TICE BCG shortage has made access the binding constraint on care in the urology setting." Limitations The QUILT-3.032 versus NCT02773849 and QUILT-3.032 versus SunRISe-1 analyses are unanchored, population-adjusted indirect treatment comparisons and should be interpreted with caution. Some baseline variables were not mutually reported across trials, including tumor grade, size, number of tumors, recurrence classification (relapse versus refractory), and timing of recurrence, limiting the ability to fully verify comparability across all clinically meaningful dimensions. Residual confounding was mitigated by including all reported prognostic variables and treatment effect modifiers in the adjustment process, and stability of results was assessed through sensitivity analyses and E-value tipping-point analyses. About ANKTIVA® (nogapendekin alfa inbakicept-pmln) The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. Important Safety Information U.S. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA® at Anktiva.com. Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio's FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit https://immunitybio.com/rbcg/. About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient's immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the potential clinical and commercial implications of the comparative effectiveness data presented at AUA 2026; future regulatory interactions and potential label expansions; the continued development and potential approval of the Tokyo strain of BCG and recombinant BCG (rBCG); the scope and duration of ImmunityBio's Expanded Access Program for rBCG; and statements regarding ImmunityBio's broader pipeline, strategy, and future growth. These forward-looking statements are based on ImmunityBio's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: the inherent limitations of indirect treatment comparisons and the possibility that head-to-head clinical trials may yield different results; the FDA's review and acceptance of any future regulatory submissions; ImmunityBio's ability to manufacture, supply, and commercialize ANKTIVA® and BCG products at sufficient scale; competition from other NMIBC therapies; the continued availability of BCG and ANKTIVA®; reimbursement and market adoption of NAI+BCG; clinical, regulatory, and commercial risks associated with ANKTIVA® and the Company's broader pipeline; intellectual property risks; macroeconomic and geopolitical conditions; manufacturing and supply chain challenges; and the additional risks and uncertainties identified in ImmunityBio's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K filed on February 23, 2026 and subsequent Quarterly Report on Form 10-Q filed on March 7, 2026, available at www.sec.gov. The forward-looking statements in this press release speak only as of the date hereof, and ImmunityBio undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260519701430/en/ ImmunityBio Contacts: Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1-858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com Media
Sarah Singleton
ImmunityBio, Inc.
+1-415-290-8045
Sarah.Singleton@ImmunityBio.com Original: ImmunityBio Presents Favorable Comparative Effectiveness Data in Complete Response Rates of NAI + BCG Versus Nadofaragene and TAR-200 at AUA 2026

Thanks for that amazing summary

ImmunityBio Shares Rise After Securing Five New U.S. Patents for Bladder Cancer Therapy (IBRX)May 18, 2026 10:35 AM
IH Market News Stock Moves Higher Following Patent Announcement Shares of ImmunityBio (NASDAQ:IBRX) gained 4.5% in premarket trading on Monday after the company announced the issuance of five U.S. patents tied to its ANKTIVA plus BCG therapy for bladder cancer treatment.The patents cover the combination of ImmunityBio’s IL-15 receptor agonist ANKTIVA with Bacillus Calmette-Guérin (BCG) for treating non-muscle invasive bladder cancer and extend protection through at least 2035. Patent Portfolio Covers Multiple Treatment Approaches According to the company, the newly granted patents include protections for methods of treating non-muscle invasive bladder cancer, including BCG-naïve disease.The intellectual property portfolio also covers defined-dose pharmaceutical formulations aligned with the approved intravesical ANKTIVA plus BCG regimen, as well as commercial two-vial treatment kits.The newly issued patents are U.S. Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432.These patents protect treatment methods involving administration of BCG together with ANKTIVA, pharmaceutical combinations using BCG and IL-15 complexes, and the company’s commercial kit structure. Company Expands Commercial and Clinical Position ImmunityBio said the expanded patent protection strengthens its commercial franchise for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer.The portfolio also supports the company’s pending supplemental biologics license application targeting BCG-unresponsive papillary-only disease, as well as the ongoing QUILT-2.005 registrational study comparing ANKTIVA plus BCG against BCG alone in BCG-naïve patients. Agreement With Japan BCG Laboratory Also Covered The patent portfolio additionally supports ImmunityBio’s exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo-172 BCG strain.The company noted that the agreement is backed by positive Phase III SWOG S1602 trial results showing non-inferiority of Tokyo-172 BCG versus TICE BCG in terms of high-grade recurrence-free survival among 984 randomized patients with BCG-naïve high-grade non-muscle invasive bladder cancer. CEO Highlights Revenue Growth Richard Adcock, President and Chief Executive Officer of ImmunityBio, said the company is generating 700% year-over-year revenue growth while continuing to broaden the clinical use of ANKTIVA plus BCG across multiple non-muscle invasive bladder cancer indications.ImmunityBio stock price Original: ImmunityBio Shares Rise After Securing Five New U.S. Patents for Bladder Cancer Therapy (IBRX)

ImmunityBio Announces Comprehensive U.S. Patents Covering Combination of ANKTIVA with BCG for Cancer Treatment, with Terms Through 2035May 18, 2026 7:30 AM
Business Wire Five issued U.S. patents cover the combination of ImmunityBio’s IL-15 receptor agonist (NAI) with Bacillus Calmette-Guérin (BCG) for non-muscle invasive bladder cancer treatment, with terms extending through at least 2035 Claims cover methods of treating non-muscle invasive bladder cancer (NMIBC) including BCG-naïve disease, defined-dose pharmaceutical compositions matching the approved NAI + BCG intravesical regimen, and two-vial commercial kits Portfolio reinforces ImmunityBio's IL-15 receptor agonist plus BCG position as the Company executes its exclusive U.S. Tokyo-172 BCG supply agreement with Japan BCG Laboratory and continues to develop Recombinant BCG (rBCG) to enhance USA supply ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage immunotherapy company, today announced that five United States patents have been issued to ImmunityBio covering the combination of its IL-15 receptor agonist ANKTIVA® (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for the treatment of cancer. The five patents (U.S. Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432) with terms extending through at least 2035 include compositions of combinations of ANKTIVA and BCG. Together they protect the approved ANKTIVA plus BCG product, the specific intravesical dosing regimen, the two-vial commercial kit, and methods of treating non-muscle invasive bladder cancer (NMIBC) including BCG-naïve disease and bladder cancer. The issued patent portfolio establishes composition-of-matter and method-of-use protection for ImmunityBio’s IL-15 receptor agonist and BCG combination platform through the next decade and beyond. This intellectual property position supports the Company’s commercial ANKTIVA plus BCG franchise in BCG-unresponsive NMIBC and bladder cancer, its pending supplemental BLA for BCG-unresponsive papillary-only disease, and the advancing QUILT-2.005 registrational trial evaluating ANKTIVA plus BCG versus BCG alone in BCG-naïve NMIBC carcinoma in situ. The patent portfolio also intersects with ImmunityBio’s recently announced exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo strain of BCG (Tokyo-172), which is supported by the positive Phase III SWOG S1602 results demonstrating non-inferiority of Tokyo-172 BCG versus TICE BCG on high-grade recurrence-free survival (HR 0.82; 95.8% CI 0.63–1.08) in 984 randomized patients with BCG-naïve high-grade NMIBC. As ImmunityBio engages with the FDA to pursue U.S. approval of Tokyo-172 BCG, the issued patent estate protects the combination of any approved BCG strain with the Company’s IL-15 receptor agonist platform. “Over the past decade, we have built an integrated immunotherapy platform grounded in the science of IL-15 and its capacity to activate NK cells, CD8+ T cells, and memory T cells without expanding suppressive regulatory T cells. These five issued patents protect that science at every layer that matters commercially: the compositions of matter, the method of treatment, the wild-type and mutant IL-15 plus BCG compositions, the intravesical dosing regimen, and the two-vial kit physicians administer. The IL-15 and BCG combination is the backbone of our bladder cancer franchise, and this patent estate protects it through at least 2035. In a similar vein, ImmunityBio has received issued patents covering the combination of ANKTIVA with checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. “This patent portfolio provides long-term protection for a cornerstone of ImmunityBio’s commercial franchise at a time when we are expanding the clinical utility of ANKTIVA plus BCG across multiple NMIBC settings, securing a second BCG supply source for the U.S. market, and generating 700% year-over-year revenue growth. The combination of durable patent protection, validated clinical data, and supply chain diversification positions ANKTIVA plus BCG as the standard of care in this disease for years to come,” said Richard Adcock, President and Chief Executive Officer of ImmunityBio. U.S. Patent No. 11,173,191 (issued November 16, 2021) covers the core method of treating cancer by administering BCG together with the IL-15N72D:IL-15RaSu/Fc complex (ALT-803/ANKTIVA), with dependent claims specific to bladder cancer, NMIBC, BCG-naïve NMIBC, and intravesical administration. This is the foundational method-of-treatment claim that reads directly on the FDA-approved use of ANKTIVA plus BCG. U.S. Patent No. 11,679,144 (issued June 20, 2023) covers the pharmaceutical composition combining BCG with a wild-type IL-15:IL-15RaSu complex, including the two-vial kit format (one vial BCG, one vial IL-15:IL-15RaSu, plus directions for use in treating cancer including bladder cancer). This broadens composition and product-form protection beyond the IL-15N72D mutant to wild-type IL-15 combinations. U.S. Patent No. 11,890,323 (issued February 6, 2024) covers the method of treating NMIBC, including BCG-naïve NMIBC, by intravesical instillation of BCG plus a wild-type IL-15:IL-15RaSu complex. This patent pairs with 11,173,191 to cover both the IL-15 mutant and wild-type forms of the combination, closing a potential design-around route. U.S. Patent No. 12,268,731 (issued April 8, 2025) covers the defined-dose composition itself: a single intravesical dose, matching the ANKTIVA plus BCG dosing regimen used in the FDA-approved label and in the QUILT-3.032 and QUILT-2.005 trials. Claims also cover the corresponding two-vial bladder cancer treatment kit. U.S. Patent No. 12,318,432 (issued June 3, 2025) covers the commercial two-vial kit itself: a first vial of BCG and a second vial of ANKTIVA (dimeric IL-15RaSu/Fc plus two IL-15N72D molecules) with instructions for treating neoplasia. This patent protects the as-supplied product configuration that physicians receive and administer. About ANKTIVA® (nogapendekin alfa inbakicept-pmln) The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. Important Safety Information U.S. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA® at Anktiva.com. Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio's FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit https://immunitybio.com/rbcg/ About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient's immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements including, but are not limited to, statements regarding the expected benefits, scope, validity, enforceability, and commercial value of ImmunityBio's patent portfolio; the expected duration of patent protection for ANKTIVA® in combination with BCG through at least 2035; the potential for patent term extensions or adjustments; the commercial and competitive advantages afforded by the issued patents; the Company's ability to maintain and expand its intellectual property position around IL-15 receptor agonist and BCG combinations; expectations regarding the QUILT-2.005 registrational trial and potential supplemental BLA approval for BCG-unresponsive papillary-only disease; anticipated revenue growth and market expansion for the ANKTIVA plus BCG franchise; the successful development and U.S. regulatory approval of Tokyo-172 BCG; and the Company's ability to execute its U.S. supply agreement with Japan BCG Laboratory. These forward-looking statements are based on management's current expectations and are subject to risks and uncertainties, known and unknown, that may cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to: challenges to the validity or enforceability of our patents in litigation or administrative proceedings; potential infringement claims by third parties; the possibility that competitors may design around our patents or develop alternative therapies; uncertainties regarding patent term extension or adjustment calculations; the risk that regulatory authorities may not approve Tokyo-172 BCG or the supplemental BLA for papillary-only disease; changes in patent laws and regulations; the outcome of ongoing and future clinical trials; market acceptance of ANKTIVA plus BCG; manufacturing and supply chain risks; and other factors discussed in ImmunityBio's filings with the U.S. Securities and Exchange Commission (SEC), including the "Risk Factors" sections of the Company's Annual Report on Form 10-K filed on February 23, 2026 and most recent Quarterly Report on Form 10-Q filed on May 7, 2026. ImmunityBio undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. View source version on businesswire.com: https://www.businesswire.com/news/home/20260518605297/en/ Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com Original: ImmunityBio Announces Comprehensive U.S. Patents Covering Combination of ANKTIVA with BCG for Cancer Treatment, with Terms Through 2035

A man walks out of his oncologist's office with a normal-looking blood test. Hemoglobin: fine. Neutrophils: fine. There is a third line on that same sheet almost nobody reads back to him. It is the one that tracks whether he lives.

On Saturday, in a room of urologists at the AUA annual meeting,
@DrPatrick
stood up and explained why that line goes untreated. Then he kept going - announcement after announcement, on a stage, on the record. Here is what he said.

THE THIRD LINE

On the AUA stage Saturday, Soon-Shiong said: "We've addressed anemia, we've addressed neutropenia, we've never addressed lymphopenia. And ironically... chemo and radiation causes lymphopenia. Now you begin to see the frustration and the madness of what we are doing."

That is the whole thesis in three sentences. Every routine blood test counts three things chemo and radiation knock down: red cells, infection-fighting neutrophils, and lymphocytes - the T cells and NK cells that kill cancer. Medicine built a drug to rebuild the red cells. A drug to rebuild the neutrophils. For the third - the cancer-killing one - nothing. The drugs given so patients can tolerate more chemo never touched the cell line chemo itself depletes.

How much does that third line matter? Not a company number - a 31,178-person US population study (Zidar et al., JAMA Network Open, 2019):

- Severe lymphopenia, all-cause death: about 1.8x the risk (age- and sex-adjusted).

- Cause-specific at severe lymphopenia: roughly 3x death from cancer, 4x from cardiovascular disease, 7x from infection and pneumonia.

In plain English: a $10 line on a standard blood count, that almost no oncologist treats, sorts who lives from who dies - across cancer, the heart, and infection at once. From the stage Soon-Shiong put it harder than the paper does ("if your ALC is below 2,000, your chances of dying early from all cause is 200 to 300%") - that is his framing; the published, adjusted figures are the ones above. They are damning without rounding up.

JUST A NUMBER

And here is what he says the agency said back. By his account, at a regulatory meeting with the FDA, the response to all of this was that the absolute lymphocyte count "is just a number." His reply from the podium: "PO2 is just a number - do you need oxygen? Hemoglobin A1C is just a number. Blood sugar is just a number." The same line a 31,178-person study ties to dying early at up to seven times the rate, waved off as not worth treating.

And look at which of those figures is largest. Not cancer. Infection. That is why Soon-Shiong does not present this as only a cancer drug - he extended the same logic to sepsis and infectious disease: one collapsed immune line, several different ways to die.

WHY IT EVEN WORKS

This is the part that makes the rest click, and it is textbook immunology, not a company theory. Tumors hide from the immune system's T cells by deleting a surface ID tag called MHC-I. That is why checkpoint drugs like Keytruda eventually fail: they rev up T cells, but a tumor wearing no tag is invisible to T cells no matter how revved. Loss of that tag is a documented mechanism of checkpoint-inhibitor resistance.

Now the elegant part, known to immunology for thirty years. NK cells run the opposite logic. A normal cell shows the tag and the NK cell passes it by. A cell that has dropped the tag screams "missing self" - and the NK cell destroys it. The tumor's single best trick against T cells is the exact signal that turns NK cells loose.

In plain English: every cell wears one ID badge. The T cell is a guard who can only grab a troublemaker he matches to his list, and the only way he checks is by reading that badge. A cancer cell that rips its badge off goes invisible to him. No badge, nothing to read, nothing he can do. Giving that guard more muscle (checkpoint drugs like Keytruda) changes nothing, because there is still no badge to read. The NK cell is the opposite kind of guard, with one rule: no badge, you are out. So the cancer's smartest escape from the first guard is the exact thing the second guard exists to catch.

ANKTIVA is the growth factor for those NK cells and T cells. It comes through the door the tumor opens when it slams the other shut. That mechanism is written into the federal label - section 12.1 states it is an IL-15 receptor agonist that stimulates CD8+ and CD4+ T cells and NK cells without expanding the regulatory T cells that would otherwise blunt the response. Soon-Shiong told the room he worked "desperately hard" to get that sentence into the label and is "not aware of any medicine in the history of medicine" carrying it. The cell line the death-predicting blood test measures is the cell line the label says the drug rebuilds.

THE FIRST PROOF IT MOVES THE LINE

For the first time, on that stage, he showed a randomized comparison from a lung-cancer trial: ANKTIVA plus Keytruda against Keytruda alone, with the same starting lymphocyte count. Over 27 weeks the ANKTIVA arm's count rose and held while the control arm's drifted down (P=0.0065). In the subgroup with the highest level of a key tumor marker, the ANKTIVA patients also went longer before their cancer progressed - a median of 7.0 months versus 2.2 (hazard ratio 0.40). It is his data, shown for the first time and not yet peer-reviewed - but it is the first randomized human signal that the drug raises the exact line that predicts who lives, and that raising it tracks with the patient doing better. (In a separate, earlier lung study he showed the patients whose count recovered lived a median 17.4 months versus 11.8 for those whose did not - he flagged that one himself as a correlation, not a randomized proof. The honest weight is on the randomized result above.)

In plain English: imagine a patient, Tom, with advanced lung cancer. Tom and a matched group all start the standard immunotherapy, Keytruda, with their cancer-killing lymphocyte count at the same level. Half of them, Tom included, also get ANKTIVA. Over the next six months Tom's group sees that count climb and hold; the Keytruda-only group watches theirs sag - and that split was not chance (the odds of a fluke were well under one in a hundred). Among the patients whose tumors carried the most of the marker immunotherapy keys off, Tom's group went about three times longer before the cancer started growing again, roughly seven months instead of two. It is a first look at his own data, not yet peer-reviewed. But it is the first time, with the comparison built in, that the drug has been shown to lift the very line that tracks who survives - and for that lift to move with the patient doing better.

THE DOCUMENT, AGAIN

So the drug raises the line, and raising the line tracks with living longer. The question that should follow - then why is it not everywhere? - has an answer, and it does not start with the drug. It starts in 2007.

In 2007 the US government answered a question oncology rarely asks out loud: of every immune molecule known, which has the best shot at curing cancer? The National Cancer Institute polled the field - NIH, the FDA, the major cancer societies. Out of more than a hundred, one came first: in Soon-Shiong's words from the AUA podium Saturday, "the number one that could address cancer is IL-15." ANKTIVA is built on it.

Then he added the part that should stop you. He had discussed that government ranking on the Sean Spicer show, and, he said, "I got a warning later about talking about a nice NCI document."

Sit with that.

Nearly two decades after the FDA sat among the bodies that ranked this molecule number one, the agency sent the man building it a warning letter for citing that ranking on air.

The ranking went to print in 2008 under a title the agency cannot take back: Mac Cheever, Immunological Reviews, "Twelve immunotherapy drugs that could cure cancers." IL-15 at the top. He didn't write that list. The government did, and the FDA was in the room.

On that same list, checkpoint inhibitors ranked second. The industry poured itself into number two - by his account more than forty approvals across tumor types, many of them won on the kind of single-arm trial we are about to come back to. Number one waited twenty years for someone to build it.

THE RULE THEY SAID DIDN'T BEND

Still in the same talk: "When the previous heads of the FDA, Dr. Prasad and Dr. Makary said... no trial has ever been approved for single arm, that's not true... Merck got it approved for single arm trial for 149 patients for all tumor types."

He is right, and this one is fully checkable. On May 23, 2017 the FDA gave Keytruda the first-ever tissue-agnostic cancer approval on 149 patients across five single-arm trials. The standard the prior CBER leadership held ANKTIVA to is one the agency itself waived for the market leader, on 149 single-arm patients. We built the file on that asymmetry; he said it to a room of urologists.

Stay on that for a second.

The two people who pressed that standard ran US drug approval. Dr. Vinay Prasad was Director of CBER, the FDA center that regulates biologics, which is to say the center that regulates ANKTIVA. Dr. Marty Makary was the FDA Commissioner.

What they said was untrue was not some obscure footnote. It was their own agency's most famous modern cancer approval. How do the two officials gatekeeping this drug get the single most checkable fact in their own building wrong, and then invoke it as the reason to make the drug wait?

And by the time Soon-Shiong called them "the previous heads" on Saturday, both were already gone. Prasad left the FDA at the end of April. Makary resigned on May 12, four days before the talk, and the day before he was scheduled to testify before a Senate subcommittee. The men who set the standard against this drug were out the door while the FDA's own record kept disproving it.

And it is not only that 2017 record. By his account on that stage, the same FDA has already granted ANKTIVA Expanded Access for any patient who has failed chemotherapy, radiation, and a checkpoint inhibitor, across cancers. Expanded Access is not a verdict on whether a drug works; it is the agency judging it safe enough to give patients with nothing left to try. So the FDA has opened a broad door to this drug for those patients, while the narrow approval that would let earlier ones through still sits unanswered. His objection to that sequence was the obvious one: why force a patient to fail everything else before being allowed this at all? That is his account from the stage, not an FDA letter we have read.

THE SECOND SOURCE

ANKTIVA is only approved given together with BCG. No BCG, no ANKTIVA - that is the label, not a preference. And BCG in the US has been a one-company, one-strain shortage for over a decade. We walked through that history yesterday.

So on Saturday he announced he had locked exclusive US rights to a second strain, Tokyo-172. The obvious doubt writes itself: a company secures its own backup and naturally swears it works. Here is why that doubt does not hold. He did not run the trial that proves it. The US government did - SWOG, the NCI-funded cooperative group, in a nine-year randomized head-to-head (Svatek et al., 2026): Tokyo-172 against the only US-approved strain. Result: non-inferior.

The part his own slide left out, kept here: that result held for the standard way of giving it; a second dosing schedule in the same trial did not work; and serious side effects ran somewhat higher with Tokyo-172. A proven equal, not a gentler one - and the government, not the company, paid for the proof.

Which is why his one blunt line on stage matters: "our approval just says any BCG. It doesn't say TICE." Hear what he is signalling. ANKTIVA's label never named Merck's strain, and the government's own nine-year trial just proved a second strain works. Tokyo-172 still needs the FDA to clear it. And Seth Lerner, the SWOG genitourinary chair he credited for that trial, is on the program at this week's FDA workshop: the proof is already in the FDA's own room, and so is the man who oversaw it.

WHAT THE SECOND SOURCE WAS REALLY FOR

The supply is not the prize. It is the runway for the prize. ANKTIVA today is approved only for patients whose cancer already came back after BCG - a fraction of the disease. BCG is given far earlier, first-line, to almost everyone who gets it. That first-line population is several times larger than the one the drug reaches today. By his account: the first-line trial, QUILT-2.005, finished enrolling in February, an independent committee reviewed it and said it had seen enough, and the application is ready to file. He says it; the FDA has not confirmed it. But the sequence is deliberate - lock a proven, government-validated BCG supply first, then file the first-line regimen that cannot exist without it, for a population many times the size of the one ANKTIVA serves now.

THE QUESTION THAT IS GENUINELY OPEN

Bladder cancer shows up in two shapes. Flat patches in the bladder lining, which doctors call carcinoma in situ, or CIS. And little finger-like growths, called papillary. ANKTIVA is already approved when CIS is present. The application that has been stuck is the one for the papillary-only form. So everything hangs on a single question: are these two shapes the same disease, or two different ones?

Soon-Shiong argues they are one - a single rogue cell line that just grows in two patterns. The science is genuinely split: some genetic studies show a shared origin; others find real molecular differences. It is honestly unsettled. That is not a footnote - it is the whole ballgame for the stuck application. And it is one of exactly two items on the agenda of the FDA's public workshop this Monday. The other item is the BCG shortage and what it does to clinical-trial design - the fight running through the rest of this post. The FDA did not convene a meeting on a side issue. It put on its agenda the two questions this drug's future turns on.

A BUREAUCRATIC RUT

And while that question waits on a workshop, the FDA's answer for the stuck application, by his account, is a randomized trial against chemotherapy.

Sit with what that asks.

Chemotherapy is the thing that causes lymphopenia - the collapsed third line a 31,178-person study ties to dying early. The comparator the agency wants is itself a driver of the harm. The problem he raised was ethical, not regulatory: how do you look a patient in the eye and randomize them into the chemotherapy arm - chemotherapy the FDA itself approved this past September, with serious adverse reactions in roughly a quarter of patients on its label - when chemotherapy is the very thing that collapses the cells keeping them alive? He said he would still run the trial. He also said he did not know how he could ethically recruit for it. He had a phrase for the loop: "a bureaucratic rut," he said. "It's not biology."

He spelled it out himself: the workshop asks "exactly the question we posed to the FDA group that's reviewing our BLA six months ago."

Sit with the timing.

Two days before the FDA sits down to decide whether CIS and papillary are one disease, the man whose stuck application hangs on that answer made the case for it - in public, to a room of the urologists who treat the disease. We called this pre-positioning before he said so. Then he said so.

THE BODY THAT ALREADY SAID YES

Here is what makes the wait extraordinary. While that question sits "open" at the FDA, it is not open at the body that writes the treatment guidelines American oncologists actually follow. This past March the NCCN added ANKTIVA plus BCG for BCG-unresponsive papillary-only disease - the exact stuck indication - as a Category 2A recommendation.

That is not a company press release.

By federal statute, Social Security Act section 1861(t)(2), a Category 1 or 2A listing in NCCN's drug compendium is a medically-accepted indication for Medicare coverage. In plain terms: the federal payer's own statutory test for what counts as covered cancer care is already met - while the FDA approval it would normally follow is not. Soon-Shiong's stage framing for it - "unanimous," "30 independent comprehensive cancer center directors," "bigger than an ODAC" - is his characterization; the guideline change and the statute are not.

THE MISSING LINK

One thing he could not announce that day: "The 60 days have passed. We've not heard anything from the FDA. We're awaiting some response. I'm hopeful."

That is the honest center of an enormous day. The first randomized proof the drug raises the line. The first-line filing ready to go. A government-validated second BCG supply locked. Saudi Arabia already approving it for lung cancer the US has not. Everything moving - except the one application that would let the next patient actually reach it. On one clinic's list, by his count, fifteen thousand of them are waiting.

The story was never whether the science works. It was whether anyone would treat the line on the blood test that decides who lives, and whether the agency that ranked this molecule number one would let the patient have it.

A foreign regulator already crossed that line - by his account the Saudi FDA accepted the whole frame, that the root cause is the collapse of the immune system and the cancer is only its symptom.

On Saturday the man who built it answered the first question, on the record, in a room of the doctors who will use it. The second answer is still sitting on a desk at the FDA, sixty days unanswered - on the very day the agency finally sits down to debate the very questions it turns on.

He gave Saturday its own name: "maybe we've actually closed the missing link." Everything in this post says he did. The last word on whether the patient ever gets it is not his.


https://x.com/ActionFixesFear/status/2056287312301142147


$IBRX WINNER

FDA should have had some input by day 60. We are now much closer to day 74 when the FDA typically delivers the 74 day letter (May 22) and it in they should specify the PDUFA date, type of review etc.


I notice Dr. Pat mentioned his meeting with the FDA (tomorrow 5/18) several times.

If you listen to his entire presentation. The FDA is the only road block he has to curing everything

https://x.com/DrPatrick/status/2056050585141698568

countdown.....
today the meeting.
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/contemporary-issues-non-muscle-invasive-bladder-cancer-nmibc-trial-design-and-interpretation

$IBRX Fantastic news on breaking the Merck monopoly!

$IBRX
must read!

A woman is told her bladder cancer has come back. Then she is told something stranger: there is a therapy the FDA approved for exactly this - and she still might not be able to get it.

Not because it failed her. Not because she can't afford it. Because it only works paired with a second drug, and that second drug has been in short supply in this country for more than a decade.

THE PROBLEM

First, what BCG is. It is the standard treatment for early bladder cancer, and has been for roughly fifty years. It is not a chemical drug. It is a live, weakened bacterium - the same one first used as the tuberculosis vaccine - put directly into the bladder to wake the immune system up against the cancer. Bladder cancer was treated with immunotherapy decades before the word was fashionable. It works. The hard part has always been getting it.

ANKTIVA is FDA-approved for bladder cancer that comes back despite BCG. The label does not say "ANKTIVA." It says ANKTIVA in combination with BCG.

So the rescue therapy for a patient whose cancer survived BCG needs more BCG.

And BCG in the United States has had one FDA-approved supplier - Merck - and one strain, in shortage since 2012, more than a decade, and allocated by Merck for years. Doctors splitting doses. Delaying patients. Turning people away.

An approved drug whose approved regimen could not always be filled. That is the problem nobody was solving.

WHAT HAPPENED SATURDAY

On Saturday, May 16, on stage at the American Urological Association annual meeting, ImmunityBio announced it had secured exclusive U.S. rights to a second source of BCG - the Tokyo-172 strain. ImmunityBio, not the manufacturer in Japan, would be the one to take it to the FDA.

Not a promise. A signed agreement, with the head-to-head trial already done.

THE DATA

The proof is SWOG S1602: a randomized Phase 3 trial run by the National Cancer Institute through a federally funded cooperative group, in patients getting BCG for the first time - the standard first-line setting. It put the Tokyo-172 strain head to head against the only BCG the FDA has approved. Presented by Svatek and colleagues at the ASCO genitourinary symposium, 2026.

The results:

- High-grade recurrence-free survival: Tokyo-172 non-inferior to the standard strain. Pre-specified non-inferiority bar met.

- 5-year high-grade recurrence-free survival: 64 percent (Tokyo-172) vs 58 percent (standard).

- This held for the straight intravesical schedule. A separate priming schedule in the same trial did not.

- Serious (grade 3-4) side effects: higher with Tokyo-172 than the standard strain.

In plain English:

"Non-inferior" means the new BCG was statistically shown to be not worse than the old one at keeping high-grade cancer from coming back. The trial set a bar in advance for how much worse it could be and still count as equivalent; Tokyo-172 stayed inside that bar. This is the result that matters for a shortage: a second source proven non-inferior in a government-run trial - not a marginally better drug.

Five years out, 64 of every 100 patients on Tokyo-172 had no high-grade recurrence, versus 58 of every 100 on the standard strain. Directionally favorable, but the trial's claim - and the honest claim - is equivalence, not superiority.

Two caveats that belong in the open: only the standard intravesical way of giving it worked; a different dosing schedule tested in the same trial failed. And serious side effects were more common with Tokyo-172. This is "as effective, by the government's own randomized data" - not "gentler."

THE PATH

Who does what, and exactly where this stands.

Done:

- The trial. SWOG S1602 was designed, run and analyzed by the National Cancer Institute and the SWOG cooperative group - publicly funded, independent of the company. It showed Tokyo-172 non-inferior to the approved strain.

- The supply. Japan BCG Laboratory, which has made this strain for decades, signed an exclusive U.S. development and supply agreement with ImmunityBio on May 16, 2026.

- The rights. ImmunityBio - not the Japanese manufacturer - is the sole U.S. applicant. ImmunityBio is the one that will file with the FDA and would hold the U.S. license.

Not yet:

- The data agreement. To use the SWOG S1602 results in a filing, ImmunityBio is still negotiating a Data Use Agreement with SWOG, the NCI and Fred Hutchinson. In discussion. Not signed.

- The FDA conversation. Engagement with the FDA on the approval path is, in the company's own words, still "to be initiated."

- The filing. The Biologics License Application is planned. It has not been filed.

- The decision. No FDA review. No approval. No date - the company has given no timeline.

- The patient. Until all of that, a U.S. patient still cannot get Tokyo-172.

What changed on Saturday is not availability. It is that the road now exists - and it runs on data the government already paid for.

WHO WAS WAITING ON WHOM

The data that underwrites this was generated by the National Cancer Institute. Federal money. A public trial. Sitting in the public domain.

Two days after the Saturday announcement - Monday, May 18 - the FDA's own Oncology Center of Excellence holds a public workshop on contemporary issues in non-muscle invasive bladder cancer. The BCG shortage and what it does to clinical trials is on the agenda. The exact problem.

The company is not on that agenda. It does not speak there. It does not need to. It had addressed the regulator's own stated problem two days before the regulator's independent panel sat down to discuss it - using a randomized trial the government itself paid for and ran. Days earlier, in public, the founder had already named the frame: "S1602 is the kind of rigorous, publicly funded science that should inform FDA decision-making."

ANNOUNCED, NOT HEARD

There was a press release. There was a post from
@DrPatrick
. None of it was hidden. It still didn't land - because supply agreements are not supposed to be dramatic, a licensing deal does not trend, and it crossed the wire on a Saturday as a few words about "exclusive U.S. supply." Most people filed it under logistics and scrolled on.

Here is what they scrolled past: a company whose only approved drug legally requires a partner product it never controlled - BCG, rationed by Merck, which competes in the same disease with its own drug - just took exclusive U.S. rights to a second, trial-proven source of it.

WHAT THIS WAS REALLY FOR

The supply story is not even the real story. The woman in this post is in the smaller group: patients whose cancer already came back after BCG. But BCG is given far earlier - it is the standard first treatment for the disease. That first-line group is several times larger than the one the approved drug covers today.

That is exactly where ImmunityBio's next bladder-cancer application is aimed: its first-line trial, QUILT-2.005, behind a BCG-naive filing the company has guided for the end of 2026 - a far larger patient population than the approved use it sells now.

That filing is also a BCG regimen. The company could not deliver it at scale without a BCG supply it controls.

So the order matters. Secure a proven BCG first - validated by the government, in exactly that first-line population - then file. The supply deal was not the headline. It was the precondition for the one still to come.

THE MISSING HALF

For two years, the question about this therapy was never whether it works. It was whether the patient could ever get all of it.

That question used to have no good answer. A single supplier. A decade of shortage. Nothing a company could do about the half it didn't own.

It owns it now. The proof is done and public. The approval is not.

For the first time, what stands between the patient and a complete, approved therapy is a regulatory path - not a shortage.

A woman is told her bladder cancer has come back. Then she is told something stranger: there is a therapy the FDA approved for exactly this - and she still might not be able to get it.

Not because it failed her. Not because she can't afford it. Because it only works paired with… pic.twitter.com/tKlXZ559yw— Freedom (@ActionFixesFear) May 17, 2026

ImmunityBio locked in exclusive U.S. rights to Tokyo-172 BCG from Japan BCG Lab — a bladder cancer treatment backed by Phase 3 data.

With the JBL agreement, ImmunityBio now has a second potential BCG source for the United States. The Company's ongoing partnership with Serum Institute of India, one of the world's largest vaccine manufacturers, supports the supply of recombinant BCG (rBCG), an investigational product. ImmunityBio will continue its FDA Expanded Access Program (EAP) for rBCG, so eligible patients can receive treatment while the regulatory path for the Tokyo strain of BCG moves forward. Taken together, the two partnerships aim to give U.S. urologists and their patients a more reliable BCG supply.

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ImmunityBio acquiring U.S. rights to Tokyo strain of BCG
More on ImmunityBio
2026-05-16 14:11:20 ET

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ImmunityBio acquiring U.S. rights to Tokyo strain of BCG

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ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG to Enhance BCG Supply in the United StatesMay 16, 2026 1:35 PM
Business Wire Positive Phase III readout of National Cancer Institute sponsored SWOG S1602 randomized clinical trial demonstrating non-inferior efficacy of the Tokyo strain of BCG (Tokyo-172 BCG) versus TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer ImmunityBio to serve as sole U.S. Biologics License Application applicant for the Tokyo strain of BCG and plans to engage with U.S. Food and Drug Administration (FDA) on regulatory pathway to address the over decade long unresolved BCG shortage in the United States Agreement positions ImmunityBio with second potential BCG source to help address U.S. supply needs Through ImmunityBio's ongoing partnership with Serum Institute of India, recombinant BCG (rBCG) remains available to eligible patients under ImmunityBio's FDA Expanded Access Program Details of the Japan BCG Laboratory agreement will be shared during Dr. Patrick Soon-Shiong’s presentation at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, on May 16, 2026 at 1:30 p.m. EDT. A link to the livestream is included below. ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory ("JBL"), the Tokyo-based developer and manufacturer of the Tokyo strain of BCG (Tokyo-172 BCG). The agreement provides ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG. JBL's Tokyo strain of BCG is supported by the February 2026 positive Phase III readout of SWOG S1602, a randomized Phase III study sponsored by the National Cancer Institute (NCI), which demonstrated non-inferiority of the Tokyo strain of BCG to TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC). The pre-specified non-inferiority margin was a hazard ratio of 1.34 (hazard ratio 0.82; 95.8% CI 0.63–1.08). The Tokyo strain of BCG is investigational in the United States and has not been approved by the FDA. Dr. Patrick Soon-Shiong will discuss the JBL agreement and provide updates on ImmunityBio’s efforts to expand BCG access and advance research in the BCG-naïve setting during his presentation, “The Role of IL-15 in the Urological Setting,” at the American Urological Association Annual Meeting on May 16, 2026 at 1:30 EDT. The presentation will also highlight the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer. A livestream of the presentation will be available through the 2026 AUA Annual Meeting website. “For more than 70 years, Japan BCG Laboratory has been dedicated to the development and manufacture of high-quality BCG products,” said Seiichi Inoue, President of Japan BCG Laboratory. “We are pleased to partner with ImmunityBio to bring the Tokyo strain of BCG to patients in the United States, and we look forward to supporting ImmunityBio in its engagement with the FDA.” ImmunityBio plans to engage with the FDA to pursue U.S. approval of the Tokyo strain of BCG and will lead all regulatory submissions, clinical development, and commercialization in the United States as the sole BLA applicant. Upon any approval, ImmunityBio will be the sole Marketing Authorization Holder. The Tokyo strain of BCG has been used in Japan for almost 30 years for the treatment of high-risk NMIBC. SWOG S1602 (NCT03091660) is a Phase III randomized controlled trial that enrolled 1,000 patients (984 eligible) between February 2017 and December 2020 with BCG-naïve high-grade NMIBC, randomized 1:1:1 to intravesical TICE BCG (n=330), intravesical Tokyo-172 BCG (n=327), or intradermal priming, followed by intravesical Tokyo-172 BCG (n=327). The pre-specified non-inferiority margin for the primary endpoint of high-grade recurrence-free survival (HGRFS) was a hazard ratio of 1.34. At a median follow-up of 4.6 years, results presented at the February 2026 ASCO Genitourinary Cancers Symposium (Svatek RS, et al. J Clin Oncol. 2026;44[7 suppl]:LBA629) demonstrated non-inferiority of intravesical Tokyo strain of BCG versus intravesical TICE BCG on the primary endpoint of HGRFS (HR 0.82; 95.8% CI 0.63–1.08), with the upper confidence bound well below the pre-specified non-inferiority margin of HR 1.34. Complete response (CR) in carcinoma in situ (CIS) at 6 months was 66.4% (Tokyo) versus 70.2% (TICE). Progression-free survival was similar across arms. The estimated 5-year HGRFS was 64% in the Tokyo arm, 58% in the TICE arm. ImmunityBio is in discussions with the SWOG Cancer Research Network, the NCI, and Fred Hutchinson Cancer Research Center to establish a Data Use Agreement that would allow incorporation of the S1602 data into the company's planned BLA submission. “SWOG and the National Cancer Institute have our deep respect for designing and completing SWOG S1602, a randomized controlled trial of approximately one thousand patients in BCG-naïve high-grade NMIBC that took nearly a decade to read out,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “S1602 is the kind of rigorous, publicly funded science that should inform FDA decision-making. Its non-inferiority finding for the Tokyo strain of BCG, alongside our rBCG partnership with Serum Institute and the FDA-approved use of ANKTIVA® with BCG in BCG-unresponsive disease, points to a future where U.S. patients with bladder cancer will have the supply and the treatment options they need.” With the JBL agreement, ImmunityBio now has a second potential BCG source for the United States. The Company's ongoing partnership with Serum Institute of India, one of the world's largest vaccine manufacturers, supports the supply of recombinant BCG (rBCG), an investigational product. ImmunityBio will continue its FDA Expanded Access Program (EAP) for rBCG, so eligible patients can receive treatment while the regulatory path for the Tokyo strain of BCG moves forward. Taken together, the two partnerships aim to give U.S. urologists and their patients a more reliable BCG supply. “U.S. urologists and their patients have lived with a chronic BCG shortage for more than a decade,” said Richard Adcock, President and Chief Executive Officer of ImmunityBio. “This agreement with Japan BCG Laboratory for the Tokyo strain of BCG gives ImmunityBio a second potential BCG source for the United States. We plan to work with the FDA on the regulatory path for the Tokyo strain of BCG. In the meantime, through our ongoing partnership with the Serum Institute of India, rBCG remains available to eligible patients through our FDA Expanded Access Program." ANKTIVA is approved by the FDA in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in-situ (CIS), with or without papillary tumors. ImmunityBio expects to provide further updates on the U.S. regulatory pathway for the Tokyo strain of BCG, including the timing of pre-FDA interactions and any anticipated BLA submission, in future communications. Important Safety Information U.S. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA® at Anktiva.com. Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio's FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit https://immunitybio.com/rbcg/ About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient's immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. About Japan BCG Laboratory Japan BCG Laboratory, headquartered in Tokyo, Japan, is a developer and manufacturer of Bacillus Calmette-Guérin (BCG) products, including intravesical BCG for bladder cancer and BCG vaccines for tuberculosis prevention. JBL has supplied BCG for more than 70 years. About ImmunityBio's Partnership with Serum Institute of India Serum Institute of India is one of the world's largest vaccine manufacturers and is ImmunityBio's manufacturing partner for recombinant BCG (rBCG). The ongoing partnership supports the continued availability of rBCG under ImmunityBio's FDA Expanded Access Program for eligible patients in the United States. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the Development and Supply Agreement with Japan BCG Laboratory; the development, regulatory pathway, manufacturing, supply, and potential U.S. commercialization of the Tokyo strain of BCG; ImmunityBio's plans to engage with the U.S. Food and Drug Administration to pursue U.S. approval of the Tokyo strain of BCG; the SWOG S1602 trial, including the interpretation and use of S1602 data in the planned BLA, and the Company's ability to enter into a Data Use Agreement with SWOG, the National Cancer Institute, and Fred Hutchinson Cancer Research Center; the continuation, scope, and impact of ImmunityBio's Expanded Access Program for recombinant BCG (rBCG) and its role in helping address the U.S. BCG shortage; the potential complementary use of the Tokyo strain of BCG with ANKTIVA®; and statements regarding ImmunityBio's pipeline and strategy. These forward-looking statements are based on ImmunityBio's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: the FDA's review and acceptance of any future BLA submission for the Tokyo strain of BCG; ImmunityBio's ability to secure a Data Use Agreement with SWOG, the NCI, and Fred Hutchinson Cancer Research Center on acceptable terms; manufacturing, supply, and import logistics for the Tokyo strain of BCG and rBCG; the continued availability of rBCG under the Expanded Access Program; clinical, regulatory, and commercial risks associated with ANKTIVA® and the Company's broader pipeline; competition; intellectual property; macroeconomic and geopolitical conditions; and the additional risks and uncertainties identified in ImmunityBio's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, available at www.sec.gov. The forward-looking statements in this press release speak only as of the date hereof, and ImmunityBio undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260516297941/en/ ImmunityBio Contacts: Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1-858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com Media
Sarah Singleton
ImmunityBio, Inc.
+1-415-290-8045
Sarah.Singleton@ImmunityBio.com Original: ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG to Enhance BCG Supply in the United States

May 16, 2026 1:35 PM Eastern Daylight Time
ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG to Enhance BCG Supply in the United States

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Positive Phase III readout of National Cancer Institute sponsored SWOG S1602 randomized clinical trial demonstrating non-inferior efficacy of the Tokyo strain of BCG (Tokyo-172 BCG) versus TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer
ImmunityBio to serve as sole U.S. Biologics License Application applicant for the Tokyo strain of BCG and plans to engage with U.S. Food and Drug Administration (FDA) on regulatory pathway to address the over decade long unresolved BCG shortage in the United States
Agreement positions ImmunityBio with second potential BCG source to help address U.S. supply needs
Through ImmunityBio's ongoing partnership with Serum Institute of India, recombinant BCG (rBCG) remains available to eligible patients under ImmunityBio's FDA Expanded Access Program
Details of the Japan BCG Laboratory agreement will be shared during Dr. Patrick Soon-Shiong’s presentation at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, on May 16, 2026 at 1:30 p.m. EDT. A link to the livestream is included below.
WASHINGTON--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory ("JBL"), the Tokyo-based developer and manufacturer of the Tokyo strain of BCG (Tokyo-172 BCG). The agreement provides ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG.

JBL's Tokyo strain of BCG is supported by the February 2026 positive Phase III readout of SWOG S1602, a randomized Phase III study sponsored by the National Cancer Institute (NCI), which demonstrated non-inferiority of the Tokyo strain of BCG to TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC). The pre-specified non-inferiority margin was a hazard ratio of 1.34 (hazard ratio 0.82; 95.8% CI 0.63–1.08). The Tokyo strain of BCG is investigational in the United States and has not been approved by the FDA.

Dr. Patrick Soon-Shiong will discuss the JBL agreement and provide updates on ImmunityBio’s efforts to expand BCG access and advance research in the BCG-naïve setting during his presentation, “The Role of IL-15 in the Urological Setting,” at the American Urological Association Annual Meeting on May 16, 2026 at 1:30 EDT. The presentation will also highlight the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer. A livestream of the presentation will be available through the 2026 AUA Annual Meeting website.

“For more than 70 years, Japan BCG Laboratory has been dedicated to the development and manufacture of high-quality BCG products,” said Seiichi Inoue, President of Japan BCG Laboratory. “We are pleased to partner with ImmunityBio to bring the Tokyo strain of BCG to patients in the United States, and we look forward to supporting ImmunityBio in its engagement with the FDA.”

ImmunityBio plans to engage with the FDA to pursue U.S. approval of the Tokyo strain of BCG and will lead all regulatory submissions, clinical development, and commercialization in the United States as the sole BLA applicant. Upon any approval, ImmunityBio will be the sole Marketing Authorization Holder. The Tokyo strain of BCG has been used in Japan for almost 30 years for the treatment of high-risk NMIBC.

SWOG S1602 (NCT03091660) is a Phase III randomized controlled trial that enrolled 1,000 patients (984 eligible) between February 2017 and December 2020 with BCG-naïve high-grade NMIBC, randomized 1:1:1 to intravesical TICE BCG (n=330), intravesical Tokyo-172 BCG (n=327), or intradermal priming, followed by intravesical Tokyo-172 BCG (n=327). The pre-specified non-inferiority margin for the primary endpoint of high-grade recurrence-free survival (HGRFS) was a hazard ratio of 1.34.

At a median follow-up of 4.6 years, results presented at the February 2026 ASCO Genitourinary Cancers Symposium (Svatek RS, et al. J Clin Oncol. 2026;44[7 suppl]:LBA629) demonstrated non-inferiority of intravesical Tokyo strain of BCG versus intravesical TICE BCG on the primary endpoint of HGRFS (HR 0.82; 95.8% CI 0.63–1.08), with the upper confidence bound well below the pre-specified non-inferiority margin of HR 1.34. Complete response (CR) in carcinoma in situ (CIS) at 6 months was 66.4% (Tokyo) versus 70.2% (TICE). Progression-free survival was similar across arms. The estimated 5-year HGRFS was 64% in the Tokyo arm, 58% in the TICE arm.

ImmunityBio is in discussions with the SWOG Cancer Research Network, the NCI, and Fred Hutchinson Cancer Research Center to establish a Data Use Agreement that would allow incorporation of the S1602 data into the company's planned BLA submission.

“SWOG and the National Cancer Institute have our deep respect for designing and completing SWOG S1602, a randomized controlled trial of approximately one thousand patients in BCG-naïve high-grade NMIBC that took nearly a decade to read out,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “S1602 is the kind of rigorous, publicly funded science that should inform FDA decision-making. Its non-inferiority finding for the Tokyo strain of BCG, alongside our rBCG partnership with Serum Institute and the FDA-approved use of ANKTIVA® with BCG in BCG-unresponsive disease, points to a future where U.S. patients with bladder cancer will have the supply and the treatment options they need.”

With the JBL agreement, ImmunityBio now has a second potential BCG source for the United States. The Company's ongoing partnership with Serum Institute of India, one of the world's largest vaccine manufacturers, supports the supply of recombinant BCG (rBCG), an investigational product. ImmunityBio will continue its FDA Expanded Access Program (EAP) for rBCG, so eligible patients can receive treatment while the regulatory path for the Tokyo strain of BCG moves forward. Taken together, the two partnerships aim to give U.S. urologists and their patients a more reliable BCG supply.

“U.S. urologists and their patients have lived with a chronic BCG shortage for more than a decade,” said Richard Adcock, President and Chief Executive Officer of ImmunityBio. “This agreement with Japan BCG Laboratory for the Tokyo strain of BCG gives ImmunityBio a second potential BCG source for the United States. We plan to work with the FDA on the regulatory path for the Tokyo strain of BCG. In the meantime, through our ongoing partnership with the Serum Institute of India, rBCG remains available to eligible patients through our FDA Expanded Access Program."

ANKTIVA is approved by the FDA in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in-situ (CIS), with or without papillary tumors. ImmunityBio expects to provide further updates on the U.S. regulatory pathway for the Tokyo strain of BCG, including the timing of pre-FDA interactions and any anticipated BLA submission, in future communications.

Important Safety Information

U.S. IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA® at Anktiva.com.

Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio's FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit https://immunitybio.com/rbcg/

About ImmunityBio

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient's immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

About Japan BCG Laboratory

Japan BCG Laboratory, headquartered in Tokyo, Japan, is a developer and manufacturer of Bacillus Calmette-Guérin (BCG) products, including intravesical BCG for bladder cancer and BCG vaccines for tuberculosis prevention. JBL has supplied BCG for more than 70 years.

About ImmunityBio's Partnership with Serum Institute of India

Serum Institute of India is one of the world's largest vaccine manufacturers and is ImmunityBio's manufacturing partner for recombinant BCG (rBCG). The ongoing partnership supports the continued availability of rBCG under ImmunityBio's FDA Expanded Access Program for eligible patients in the United States.

Tomorrow at AUA in DC

https://immunitybio.com/immunitybio-to-present-new-comparative-data-scientific-advances-in-non-muscle-invasive-bladder-cancer-cis-and-an-update-on-bcg-naive-registrational-trial-at-american-urological-association-annual-mee/

$IBRX something is cooking$$$$$$

Just learnt of this session. Important issues facing patients with papillary disease bladder cancer and patients facing shortage of BCG. These are the issues I have been discussing with FDA for a long time and will address them at our AUA talk on Saturday. Will livestream and… https://t.co/wmMe5KItHR— Dr. Pat Soon-Shiong (@DrPatrick) May 15, 2026

Contemporary Issues in Non-Muscle Invasive Bladder Cancer (NMIBC) Trial Design and
Interpretation
MAY 18, 2026

Meeting Goals:
Discuss the similarities and differences between the two types of histology (papillary and CIS) observed in NMIBC and implications for the demonstration of efficacy in clinical trials.
Examine the current state of the BCG shortage and the impact on clinical trial design.

https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/contemporary-issues-non-muscle-invasive-bladder-cancer-nmibc-trial-design-and-interpretation

Breakthrough immunotherapies, ADCs, and precision oncology platforms continue driving major investor attention across the global cancer treatment sector

New York, NY –May 14, 2026 – Market News Updates News Commentary – Momentum around solid tumor cancer treatments is picking up fast as new technologies and therapies continue delivering encouraging results across some of the hardest-to-treat cancers. From lung and breast cancer to colorectal, ovarian, and pancreatic cancers, drug developers are making real progress with next-generation immunotherapies, targeted treatments, and antibody-drug conjugates (ADCs). What’s getting the industry excited is that many of these newer therapies are showing stronger response rates while potentially causing fewer side effects than traditional chemotherapy. Large pharmaceutical companies and emerging biotech firms are pouring billions into oncology research right now, and recent clinical trial wins have only added to the optimism surrounding the space. Capitalize on the booming biotech sectors and watch these companies as they expand market reach, accelerate growth, and unlock new opportunities: GT Biopharma, Inc. (NASDAQ: GTBP), Artiva Biotherapeutics, Inc. (NASDAQ: ARTV), Fate Therapeutics, Inc. (NASDAQ: FATE), ImmunityBio, Inc. (NASDAQ: IBRX), Coherus Oncology, Inc. (NASDAQ: CHRS).



The financial opportunity tied to solid tumor treatments is also becoming impossible to ignore. Industry analysts estimate the global solid tumor market was worth roughly $431 billion in 2025 and could climb past $2.1 trillion by 2034 as cancer rates rise and more advanced therapies reach patients. At the same time, the broader cancer immunotherapy market is expected to more than double over the next several years, fueled by growing demand for precision medicine and personalized treatment approaches. Investors are paying especially close attention to companies developing therapies that target cancer at the molecular level, since those treatments are increasingly viewed as the future of oncology care.



Another major reason for the excitement is the growing success of combination therapies, where companies are pairing immunotherapies with targeted drugs or biologics to improve patient outcomes. This approach is showing promise in several aggressive solid tumor cancers where treatment options have historically been limited. The antibody-drug conjugate market alone is projected to become a multi-billion-dollar sector by the end of the decade, while lung cancer therapeutics continue to rank among the fastest-growing areas in healthcare. As more therapies move through late-stage trials and regulatory approvals continue accelerating, many analysts believe oncology could remain one of the strongest long-term growth sectors in biotech and healthcare for years to come.



GT Biopharma, Inc. (NASDAQ: GTBP) Announces First Patient Dosed in Phase 1 Trial of GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors

GTB-5550 is now the 3rd TriKE® to enter the clinic and an expansion into a broader solid tumor opportunity, with the Phase 1 trial likely to focus on prostate cancer patients during the dose escalation phase
Company anticipates providing updates in 2H 2026 as enrollment progresses through dose escalation cohorts


GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE® natural killer (NK) cell engager platform, today announced that the first patient was dosed in a Phase 1 dose escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer (NK) cell engager for solid tumors expressing B7-H3.



“Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE® platform into the broader opportunity of treating patients with a variety of solid tumors. The ongoing Phase 1 progress with GTB-3650 in hematologic malignancies now gives us the confidence to advance the platform with GTB-5550 to target B7-H3, which is broadly expressed across many of the most common and difficult-to-treat solid tumor cancers. We look forward to providing updates on the trial’s progress throughout the second half of 2026.”, said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.



The Phase 1 trial with GTB-5550 will be the first nanobody TriKE® tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial will focus primarily on enrolling prostate cancer patients and evaluate up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 1b expansion component will enroll patients with up to 7 different tumor types (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity.



“Patients with metastatic castration-resistant prostate cancer have B7-H3 expressed in over 90% of tumors and PSA can serve as an early biomarker of therapeutic activity. We look forward to evaluating GTB-5550 across multiple solid tumor types as we continue dose escalation.”, said Dr. Nicholas Zorko, MD, PhD, Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation, The University of Minnesota.



GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. Subsequent cycles receive treatment three times weekly for 2 weeks followed by 2 weeks of no treatment. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). More details can be found on clinicaltrials.gov with the identifier: NCT07541573. Continued… Read this full release and additional news for GT Biopharma by visiting: https://www.gtbiopharma.com/news-media/press-releases



Recent News, Strategic Developments, and Growth Catalysts Shaping the Biotech and Pharmaceutical Sectors Include:



Artiva Biotherapeutics, Inc. (NASDAQ: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with debilitating autoimmune diseases, recently announced positive initial clinical data from ongoing clinical trials evaluating AlloNK® (also known as AB-101) in combination with rituximab. As of the April 3, 2026 data cutoff, the initial clinical dataset includes 21 refractory RA patients with at least 12 weeks of follow-up, including 13 patients with six months of follow-up, from Artiva’s company-sponsored Phase 2a basket trial and an investigator-initiated basket trial evaluating AlloNK in B-cell driven autoimmune diseases. The broader autoimmune dataset also includes 11 SjD patients and five SSc patients, including seven SjD patients and four SSc patients with at least six months of follow-up.



Artiva also announced alignment with the FDA on a single registrational randomized controlled trial design for AlloNK in refractory RA expected to enroll approximately 150 RA patients who have had an inadequate response to two or more biologic or targeted synthetic disease modifying anti-rheumatic drugs (b/tsDMARDs) of distinct classes. Patients are expected to be randomized 2:1 to receive AlloNK plus rituximab or rituximab alone, with ACR50 response at six months as the primary efficacy endpoint.



Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune diseases, is presenting data this week featuring its off-the-shelf CAR T-cell programs FT819, FT839, and FT836 at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting to be held in Boston, MA, May 11–15, 2026.



“We are excited to highlight our leadership in delivering off-the-shelf CAR T cells with less-intensive or no conditioning chemotherapy to ensure broad patient accessibility,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. “With FT819, we are demonstrating that it is feasible to drive CAR T-cell efficacy with less-intensive or no conditioning chemotherapy in SLE and believe that eliminating the need for intensive conditioning chemotherapy has the potential to significantly improve the safety and clinical benefit of cellular therapies. With our next generation CAR T-cell programs, FT836 and FT839, we are illustrating that through precise multiplexed-engineering of iPSCs to generate clonal master banks that serve as the starting point for large scale manufacture of uniform and consistent drug product, it is feasible to tackle complex multicellular diseases, support functional persistence without the need for intensive conditioning chemotherapy, and create synergy with standard-of-care therapies to deliver effective treatments for patients with unmet need.”



ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, recently announced it will present new treatment comparison results evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus nadofaragene firadenovec-vncg and TAR-200 in patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease, at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18. An additional oral presentation will include new insights into research of intravesical recombinant BCG (rBCG) in BCG-naïve patients.



These analyses are clinically relevant for urologists managing an increasingly complex NMIBC treatment landscape, particularly among patients with BCG-unresponsive disease. In the context of limited direct comparative data, cross-trial analyses may provide important context to inform treatment selection and sequencing. By evaluating ANKTIVA + BCG relative to other available options, these data may help characterize comparative efficacy and durability of response within current treatment paradigms.



Coherus Oncology, Inc. (NASDAQ: CHRS), recently reported financial results for the first quarter 2026, and provided an overview of recent business highlights. “We are executing well on our integrated financial, commercial and development strategy that maximizes LOQTORZI’s potential in NPC and in combination with our pipeline products.” said Denny Lanfear, Coherus Chairman and Chief Executive Officer. “We also continue to explore opportunities across cancers and non-proprietary novel combinations with tagmokitug, our potentially best-in-class CCR8 Treg depleter, and are encouraged given our previously reported clinical data including anti-tumor activity, safety data, tumor biomarker data and PK data.”



“Casdozokitug is the only known clinical stage IL-27 antagonist, and the first line HCC study in combination with LOQTORZI is now fully enrolled. We are tracking to initial data around mid-year.” said Rosh Dias, MD, Chief Medical Officer. “The tagmokitug program is also on track, with continued enrollment across all cohorts. We also continue to progress the first-in-class pasritamig combination study in metastatic castration-resistant prostate cancer (mCRPC), which we anticipate initiating in the fall. We are on target for multiple data readouts as planned in 2026.”



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