How Big Can Anktiva Get? ImmunityBio’s Market After the Papillary Approval

On October 14, 2026, the FDA widened the label of Anktiva, ImmunityBio’s (IBRX) bladder cancer immunotherapy, to adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) whose tumors are high-grade and papillary only. Until then the label required carcinoma in situ (CIS). The FDA calls Anktiva the first treatment approved specifically for the papillary-only group. It accepted the application in May 2026 and acted 84 days before the January 6, 2027 target date (FDA press release, October 14, 2026; ImmunityBio 10-Q for the second quarter of 2026).

Anktiva already sells: net product revenue was $50.7 million in the second quarter of 2026, up 92% from a year earlier and higher in every quarter since launch. At the October 14 close of $9.91, the market valued ImmunityBio at about $10.5 billion, roughly 52 times its second-quarter sales annualized (IBRX on BioRadar; our arithmetic). The company is controlled by its founder and executive chairman, Dr. Patrick Soon-Shiong. This piece builds Anktiva’s market step by step, from the approved US label to the markets ImmunityBio is still pursuing, and sets out what could slow each step down.

The terms, briefly. BCG (Bacillus Calmette-Guérin), a weakened bacterium related to the one that causes tuberculosis, is put into the bladder as the standard first treatment for high-risk NMIBC. “BCG-unresponsive” means the cancer persisted or came back soon after adequate BCG treatment. CIS is a flat form of the cancer in the bladder lining; papillary tumors grow from the lining into the bladder, and a patient can have either or both.

Jump to the three scenarios ↓

Key points

• The papillary label rests on extrapolation. The FDA applied the CIS results to high-grade papillary-only disease without a new randomized trial, calling it “a new FDA approach,” and plans to put the approach in guidance. Other drugs approved for CIS could follow the same route.
• All product sales are in the US. Anktiva sold $50.7 million in the second quarter, adding $5.4 million to $6.5 million a quarter over the past year. ImmunityBio has not reported product sales abroad, although Anktiva is authorized in 34 countries.
• The approved US market is a few thousand patients a year. Our illustrative estimate is about 6,500 new BCG-unresponsive patients a year, with a range of 3,000 to 10,000 depending on the inputs.
• The main obstacles: single-arm evidence, a BCG shortage (Anktiva is given with BCG), competitors reporting numerically higher response rates in separate trials, a cash burn of about $71 million a quarter, a revenue royalty paid to Oberland Capital and a $480 million convertible note held by Soon-Shiong’s Nant Capital.

Anktiva’s sales so far

Anktiva (nogapendekin alfa inbakicept) is an interleukin-15 (IL-15) receptor agonist that is put into the bladder together with BCG, the standard bladder cancer immunotherapy. The FDA first approved it in April 2024 for BCG-unresponsive NMIBC with CIS. Sales took off in 2025: the first quarter of 2025 was the first with a permanent billing code (J-code), and net product revenue jumped 129% from the previous quarter to $16.5 million (ImmunityBio 8-K, May 12, 2025). Full-year 2025 revenue was $113.0 million on 3,745 units (ImmunityBio 8-K, February 23, 2026). Anktiva is sold as a single-dose vial, listed at $36,516 per dose, up from $35,800 in January 2025 (ImmunityBio ordering page and state price disclosure).

The growth has since settled into a steady pace: in each of the last four reported quarters, sales rose by $5.4 million to $6.5 million over the quarter before. ImmunityBio’s quarterly report says its product revenue “was generated from U.S. sales of ANKTIVA.” The company also booked $568,000 of other revenue in the second quarter, most of it in Europe, but that is not product sales (ImmunityBio 10-Q for the quarter ended June 30, 2026).

What changed on October 14

The FDA calls the decision “a new FDA approach.” Its announcement cites only the results behind the 2024 approval in CIS: 62% of 77 patients had a complete response and, of those, 58% kept it for at least 12 months and 40% for at least 24 months. The agency “considered these results alongside clinical and laboratory evidence showing that CIS and high-grade papillary tumors share important features”: they often occur together, can be hard to tell apart under a microscope, and carry a high risk of returning or progressing once BCG stops working. It concluded that the CIS efficacy “could be extrapolated” to high-grade papillary disease and says it will describe the approach in its final guidance (FDA press release and approval notice, October 14, 2026).

That is a change of course. In its review of the 2024 approval, the FDA wrote that “a randomized trial with a time-to-event endpoint would be required to demonstrate benefit in patients with papillary-only disease” (FDA approval summary, Clin Cancer Res 2025). ImmunityBio says the FDA advised it in January 2025 to file, then in May 2025 refused to file the application “on the basis of requiring a randomized controlled trial (RCT) against chemotherapy.” After further meetings and additional data, the FDA accepted the application in May 2026 (ImmunityBio 8-K, July 25, 2025; 10-Q for the second quarter of 2026). Separately, a Phase 3 trial ImmunityBio registered in a different papillary population, BCG-naive or BCG-exposed patients, comparing Anktiva plus BCG with BCG alone (NCT07551544), is listed as withdrawn by “sponsor decision” with no patients enrolled; the registry gives no further reason.

The papillary patients in the main trial do have published results. In 80 patients, estimated disease-free survival was 58.2% at 12 months, 52.1% at 24 months and 38.2% at 36 months, with no comparison group (Chang et al., J Urol 2026). Without a control arm those numbers are hard to read: in a March 2026 warning letter about Anktiva promotion, the FDA wrote that because QUILT-3.032 was single-arm “and DFS is a time-to-event efficacy endpoint, the reported DFS results are uninterpretable” (FDA warning letter, March 13, 2026). The NCCN treatment guidelines had moved first, listing Anktiva plus BCG for papillary-only disease since March 2026 (ImmunityBio 8-K, May 7, 2026).

The market, step by step

We found no official count of Americans who become BCG-unresponsive each year, and ImmunityBio does not publish its own estimate. The figures below are an illustrative estimate built from published rates, with every input shown so readers can change them.

Step 1: patients who start BCG. About 84,530 Americans will be diagnosed with bladder cancer in 2026 (SEER). About 70% to 80% have non-muscle invasive tumors (NCI PDQ); we use 75%. The high-risk share depends on the definition: it was 57% in a population study from Alberta (Gotto et al., 2025) and is lower under stricter definitions; we use 40%. About 60% of high-risk patients received BCG in US Medicare data for 2017 (Kennedy-Yoon et al., Urology 2026). That gives about 15,200 patients a year who start BCG for high-risk disease (84,530 × 0.75 × 0.40 × 0.60).

Step 2: those who become BCG-unresponsive. At Moffitt Cancer Center, 225 of 1,076 BCG-treated patients, about 21%, became BCG-unresponsive during follow-up (Jazayeri et al., Eur Urol Focus 2026). Applied to 15,200, that is about 3,200 a year. This assumes a steady flow of patients; the Moffitt figure is a share over years of follow-up at one center, not a one-year rate.

Step 3: patients who were not high-risk at first. In a study of 2,554 BCG-unresponsive patients in eight countries, only 48.9% had been classified high-risk when first diagnosed; the rest started as intermediate-risk (Broughton et al., BMC Urol 2022). Steps 1 and 2 count only patients who were high-risk at diagnosis, so we divide 3,200 by 0.489, which gives about 6,500 a year. Broughton’s figures come from a retrospective chart review in which physicians in eight countries each picked their last ten eligible patients, so the ratio may not describe the yearly US flow.

With 70% non-invasive tumors and no step 3, the estimate falls to about 3,000; with 80%, Alberta’s 57% and step 3, it rises to about 10,000. That range shows how far the answer moves with the inputs; it is not a statistical confidence interval, and the whole calculation is a scenario, not a validated epidemiological forecast. A third of Broughton’s patients (33.6%) had papillary-only disease, which splits our central 6,500 into about 4,300 with CIS and 2,200 papillary-only.

What a patient is worth. In the second quarter of 2026, ImmunityBio booked $50.7 million on 1,713 units, about $29,600 per dose, against about $30,800 in the fourth quarter of 2025 (investor presentation, August 2026; our arithmetic). The median trial patient received 12 doses (label section 6.1), so a median course is worth about $355,000 in net revenue: less than the first-year drug cost in the price table below, which counts 15 scheduled doses at Medicare’s rate. A median is not an average, and patients who keep responding can stay on treatment for up to 37 months, so this is a yardstick, not a measured revenue per patient. The second quarter’s 1,713 units equal about 6,900 doses a year, the median dose count of roughly 570 patients; many doses go to patients already in maintenance, so this is a gauge of scale, not a patient count.

Swipe the table sideways to see every column.

Sources: SEER, NCI, the studies above, GLOBOCAN 2024 (EU-27), ImmunityBio filings; our arithmetic at the second-quarter 2026 net revenue per dose. Real shares will be lower than 100%.

For the approved US label, the model gives about $2.3 billion a year at full share and about $580 million at a one-in-four share; these are outputs of the assumptions above, not observed market data. ImmunityBio’s market value of about $10.5 billion is roughly four and a half times the full-share figure, which suggests investors are also pricing in expansion, higher prices or a long growth runway; the filings cannot say which.

The expansion steps each have their own hurdle (lung cancer is covered further down):

• BCG-naive patients. The largest pool. ImmunityBio plans a 2026 filing based on QUILT-2.005, an open-label randomized trial of 369 patients whose primary endpoint in CIS is the complete response rate at 6 months; its estimated primary completion date was September 30, 2026, and final results have not been announced (NCT02138734; ImmunityBio 8-K, August 4, 2026). ImmunityBio’s investor presentation cites complete responses at 9 months of 84% with Anktiva plus BCG against 52% with BCG alone, from an FDA-requested interim analysis that the slide labels n=43, without counts for each arm (investor presentation, August 2026). The bar is AstraZeneca’s (AZN) Imfinzi plus BCG, approved for BCG-naive high-risk NMIBC in May 2026 on a randomized trial of 1,018 patients (FDA notice, May 28, 2026).
• Outside the US. Anktiva is authorized in the UK (July 2025), Saudi Arabia (January 2026), the EU (February 2026) and the UAE (July 2026), with Accord Healthcare selling it in the EU (ImmunityBio 8-Ks, February 23 and July 29, 2026). The EU authorization is conditional and covers CIS only, and prices are set country by country by public payers.

Who else is competing for the same patients

Removing the bladder (radical cystectomy) has been the standard of care, but its 90-day mortality is 1% to 7%, and up to 15% in elderly patients. For those who cannot or will not have it, doctors also use off-label chemotherapy in the bladder, such as gemcitabine, docetaxel and mitomycin (FDA approval summary, Clin Cancer Res 2025). Three other branded drugs are approved for the CIS form, and two more are heading to the FDA:

Swipe the table sideways to see every column.

Sources: FDA approval notices and reviews; CG Oncology 10-Q for the second quarter of 2026; enGene 8-Ks, May 7 and September 8, 2026. These are separate single-arm trials with different rules for confirming a response, such as mandatory biopsies and central pathology review, so their rates cannot be ranked against each other.

Three things matter for Anktiva’s share:

• Its papillary-only lead may not last. The FDA says the new approach “may also help guide the development of future treatments,” and drugs already approved for CIS are the obvious candidates. Inlexzo reported an estimated disease-free survival of 70.2% at 12 months in its own papillary-only cohort of 52 patients (Daneshmand et al., J Clin Oncol 2025), against 58.2% in Anktiva’s cohort; no trial has compared the two directly.
• Among the treatments compared here, it is the only one that needs BCG, which matters while BCG is short (see below).
• The next market is contested too. In BCG-naive disease, Imfinzi plus BCG already has randomized evidence: a disease-free survival hazard ratio of 0.68 against BCG alone (FDA notice, May 28, 2026).

On drug price, Anktiva sits in the middle of the group. At Medicare’s payment limits for the fourth quarter of 2026, the drug alone for the first year on each label’s schedule costs roughly:

Swipe the table sideways to see every column.

Sources: CMS payment limit file, October 2026; FDA labels; our arithmetic. Doses are counted from the first dose through day 364 for a patient who stays on treatment; many stop earlier. Drug only: excludes BCG (about $177 per Anktiva instillation), administration and monitoring.

What could slow it down

BCG is in short supply

Anktiva is approved only in combination with BCG, and BCG is scarce. Merck is the sole maker of TICE BCG for the US market, and ImmunityBio’s quarterly report calls the shortage a “market headwind” that could limit the number of patients treated (ImmunityBio 10-Q, August 4, 2026). The company is working on two alternatives: a recombinant BCG from the Serum Institute of India, for which the FDA authorized expanded access in February 2025, and the Tokyo-172 strain, for which it secured exclusive US rights from Japan BCG Laboratory in 2026 (ImmunityBio 8-Ks, March 3, 2025 and August 4, 2026). Neither is approved for routine use, and the Anktiva label states that studies of its efficacy with other BCG products “have not been conducted.”

The evidence behind the approved uses is single-arm

In the FDA’s review of the CIS cohort, 62% of 77 patients had a complete response; counted against all 77, 36.4% had one lasting at least 12 months and 14.3% at least 36 months. The FDA called the 45-month median duration of response “unreliable” because of the few events, but judged the response rate and duration “clinically meaningful,” “including some patients with several years of durable responses” (FDA approval summary, Clin Cancer Res 2025). The European Medicines Agency granted only a conditional authorization, for CIS, and calls the main trial “small, short-term” (Anktiva EPAR). The label warns that delaying cystectomy “could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal”; 8 of the 77 CIS patients (10%) progressed to muscle-invasive disease (label section 5.1). In bladder cancer, randomized evidence will come from QUILT-2.005, which enrolls BCG-naive patients rather than the BCG-unresponsive patients on the label.

Promotion is under FDA scrutiny

The March 2026 warning letter from the FDA’s Office of Prescription Drug Promotion found two pieces of promotion false or misleading: a television ad aimed at patients, and Soon-Shiong’s January 19, 2026 appearance on The Sean Spicer Show, which ImmunityBio posted on its website as “Is the FDA BLOCKING Life Saving Cancer Treatments?” It followed untitled letters from September 2025 and January 2026, asked for corrective messages to the same audiences, and warned that unfixed violations “may result in legal action without further notice” (FDA warning letter, March 13, 2026). The letter did not affect the approval, but it holds the company’s claims to the label.

Manufacturing has stalled approvals before

The FDA’s first decision on Anktiva, in May 2023, was a complete response letter. The deficiencies related to the FDA’s inspection of ImmunityBio’s third-party contract manufacturers, plus further chemistry, manufacturing and controls issues; no new efficacy trials were requested (ImmunityBio 8-K, May 11, 2023). Approval followed in April 2024 after a resubmission. New indications, presentations and BCG sources can raise the same questions again.

Approvals abroad are not yet sales abroad

Thirty-four countries is a regulatory footprint, not yet a revenue base: through June 2026, all of Anktiva’s product revenue came from the US.

The money behind the growth

Sales do not yet cover costs. In the second quarter of 2026, research and development cost $60.8 million and selling, general and administrative expenses $51.8 million, against $50.7 million of product revenue, and operating activities used $141.9 million of cash in the first half (ImmunityBio 8-K, August 4, 2026; 10-Q). Cash and marketable securities were $357.4 million on June 30, about 15 months of runway from that date at the first-half burn rate (Dilution Watch; our arithmetic).

Four features of the capital structure matter for anyone sizing the upside:

• A royalty on sales. Oberland Capital has paid $375 million ($200 million in December 2023, $100 million in May 2024 and $75 million in March 2026) for tiered payments of 5.625% to 12.5% of worldwide net sales outside China. If Oberland has received at least $375 million by December 31, 2029, the rate falls to 2.8125%. If not, ImmunityBio must make a one-time True-Up Payment of the difference, and the rate rises from then on. The payments end once Oberland has received 195% of what it paid, about $731 million; if that has not happened by the agreement’s twelfth anniversary, in December 2035, ImmunityBio must pay the remainder (10-Q; our arithmetic).
• A large convertible held by Soon-Shiong’s company. Nant Capital holds a $480 million note at Term SOFR plus 8%, due December 31, 2027, convertible at any time at $5.427 a share. Converting the principal would add about 88 million shares and retire the debt (10-Q; our arithmetic).
• Steady equity sales. ImmunityBio raised $147.2 million net through its at-the-market program in the first half of 2026 and had $349.2 million of capacity left on June 30. Of 47.9 million warrants at $3.10 to $3.29 outstanding on June 30, 6.4 million were exercised in July. There were 1,059.8 million shares outstanding on July 31, 12% more than a year earlier. Counting the note’s 88 million shares and the roughly 41 million remaining warrants, the share count would be about 1.19 billion, a market value of about $11.8 billion at $9.91 (10-Q; our arithmetic).
• Control. Soon-Shiong and his affiliates owned about 62.2% of the common stock on June 30, 2026. The quarterly report carries going-concern language, and says the company expects to fund the next 12 months in part because of his “intent and ability to support our operations with additional funds, including loans from affiliated entities” (10-Q).

Immunotherapy 2.0: what the bigger story rests on

Soon-Shiong presents Anktiva as the backbone of a broader platform, and ImmunityBio is also pursuing lung cancer, lymphopenia (low lymphocyte counts after cancer treatment) and blood cancers; in 2026 his Nant Capital also took a 19.9% stake in PDS Biotech (see our PDS Biotech analysis). The FDA has pushed back on the platform claims. On The Sean Spicer Show, Soon-Shiong said, “It’s approved for bladder cancer, but it actually can treat all cancers.” The FDA’s letter replied that Anktiva “is not approved as a treatment for ‘all cancers’ or lung cancer after failure of checkpoint inhibitors, nor is it approved for any form of cancer prevention,” and that the agency was “not aware of data that support the efficacy claims and representations that Anktiva can ‘cure’ cancer.”

Lung cancer is the most advanced of these programs:

• Authorized abroad, on single-arm data. Saudi Arabia (January 2026) and the UAE (July 2026) authorized Anktiva with checkpoint inhibitors for metastatic non-small cell lung cancer. ImmunityBio reports a median overall survival of 14.6 months in 79 patients from QUILT-3.055 whose cancer had progressed after checkpoint inhibitors, a trial with no control group (ImmunityBio 8-K, July 29, 2026).
• The randomized test so far was not significant. In the Lung-MAP S1800D trial, run by the SWOG network with the National Cancer Institute, N-803 (Anktiva’s development name) plus pembrolizumab was compared with standard chemotherapy. Enrollment closed at the first interim analysis, and with 44 deaths overall survival “was not significantly different between the two arms” (hazard ratio 0.73, 95% CI 0.40 to 1.36; 12-month survival 44% versus 25%) (ASCO 2024 abstract).
• Confirmatory results are years away. A Phase 3 trial, ResQ201A, is recruiting about 500 patients, with primary completion estimated for September 2028 (NCT06745908). ImmunityBio has not announced a US filing in lung cancer; in February it said it planned to discuss an accelerated approval pathway with the FDA in 2026.

The other programs are earlier still: small, mostly single-arm studies in blood cancers and an expanded access program for lymphopenia. They are options on the future rather than parts of today’s market.

Where this could go: three scenarios

This section is analysis, not a forecast. It describes paths the filed facts make possible and what each would require. We do not assign probabilities.

1. The label opens a bigger door

Promotion for papillary-only disease lifts quarterly growth well above the recent $5 million to $7 million. QUILT-2.005 produces a clear result, the FDA accepts a BCG-naive filing, a second BCG source eases supply, and Europe starts to sell. What to look for: the sales increase in the first quarter of 2027 and the QUILT-2.005 results.

2. A steady climb

Sales keep adding roughly $5 million to $7 million a quarter. The papillary label adds less than the headline suggests, because some of that use was already happening under the guidelines. Competitors gain ground, and cash needs are met with share sales and support from Soon-Shiong. What to look for: growth close to the recent trend and continued share issuance.

3. Crowded and capped

Competitors that need no BCG win the papillary-only extension too, the BCG shortage persists, and the BCG-naive data fall short of the randomized standard Imfinzi set. More dilution, the Oberland royalty and the Nant Capital note take a larger part of the value per share. What to look for: quarterly growth slowing below $5 million, competitor papillary filings and the terms of the next financing.

What to watch

• The third-quarter report, expected in early November; the fourth quarter, the first with the papillary label in place for part of the quarter; and the first quarter of 2027, the first full quarter.
• QUILT-2.005 results and the planned BCG-naive filing.
• Whether other drugs approved for CIS, such as Inlexzo, ask the FDA for the same papillary-only extension, and when the FDA finalizes its guidance.
• CG Oncology’s cretostimogene filing, expected to be completed in the fourth quarter of 2026.
• BCG supply: progress on Tokyo-172 and recombinant BCG.
• First product sales outside the US, and the outcome of ImmunityBio’s discussions with the FDA about lung cancer.
• Cash, use of the at-the-market program and any conversion of the Nant Capital note. BioRadar’s IBRX page lists ImmunityBio’s new SEC filings in plain English.

Bottom line

Anktiva has about $200 million in annualized US sales and a label that now covers adults with BCG-unresponsive NMIBC, including high-grade papillary-only disease. The papillary approval is a first, but it came from extrapolating the CIS data, and the FDA has signaled that the same route is open to competitors, several of which need no BCG. By our illustrative estimate, the approved US market is a few thousand patients a year, worth roughly $2.3 billion a year if every one of them received a median course at second-quarter 2026 net prices; that is a scenario, not a forecast. The rest of the growth story, from BCG-naive patients to Europe and lung cancer, depends on steps that are not yet proven, and the royalty, the convertible note and continued share sales shape how much of it reaches shareholders.

FAQ

What did the FDA approve for Anktiva on October 14, 2026?

The FDA expanded Anktiva plus BCG to adults with BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors; the earlier label required carcinoma in situ. The FDA based the decision on the earlier CIS results and the similarities between the two forms of the disease, and calls Anktiva the first treatment approved specifically for the papillary-only group.

How much does Anktiva sell?

Net product revenue was $50.7 million in the second quarter of 2026, up 92% from a year earlier, and $113.0 million in 2025. All product sales so far have been in the US.

How many US patients could Anktiva treat?

We found no official annual count in the sources we checked. Using published rates, our illustrative estimate is about 6,500 new BCG-unresponsive patients a year in the US, with a range of 3,000 to 10,000 depending on the inputs; about a third of them may have papillary-only disease.

What could slow Anktiva’s growth?

The main risks are the BCG shortage, since Anktiva must be given with BCG; competitors that need no BCG, such as Inlexzo; the single-arm evidence behind the approved uses; and the company’s cash needs, royalty payments to Oberland Capital and a $480 million convertible note held by Soon-Shiong’s Nant Capital.

Corrections and updates, October 15, 2026: the QUILT-2.005 interim analysis is now described with the size shown on the company’s slide (n=43); revenue per dose now uses second-quarter 2026 units, which moved the full-share estimate from about $2.4 billion to about $2.3 billion; the detalimogene 12-month figure is now described as immature, because enGene labels it two ways; and the Oberland terms now include the True-Up Payment and the 2035 payment of the remainder.

Sources

• FDA press release, October 14, 2026: FDA approves first treatment for certain people with BCG-unresponsive bladder cancer
• FDA approval notice, October 14, 2026: expanded indication for nogapendekin alfa inbakicept-pmln
• Anktiva prescribing information, revised October 2026 (posted by ImmunityBio)
• Heiss et al., Clin Cancer Res 2025: FDA approval summary for nogapendekin alfa inbakicept-pmln
• Chang et al., J Urol 2026: QUILT-3.032 papillary-only cohort
• FDA warning letter to ImmunityBio, March 13, 2026
• European Medicines Agency: Anktiva EPAR
• ImmunityBio 8-K, Exhibit 99.1, October 14, 2026
• ImmunityBio 8-K, Exhibit 99.1, August 4, 2026: second quarter 2026 results
• ImmunityBio 10-Q for the quarter ended June 30, 2026: revenue, financing, Oberland terms, ownership, BCG supply
• ImmunityBio 8-K, Exhibit 99.1, July 29, 2026: UAE authorization and updated trial figures
• ImmunityBio 8-K, Exhibit 99.1, May 7, 2026: first quarter 2026, NCCN listing
• ImmunityBio 8-K, Exhibit 99.1, February 23, 2026: 2025 results, international approvals
• ImmunityBio investor presentation, August 2026: revenue and units by quarter (slides 9 and 10), QUILT-2.005 interim analysis (slide 14) (the company replaces this file when it posts a new deck); Anktiva ordering page (list price, accessed October 15, 2026)
• ImmunityBio 8-K, Exhibit 99.1, July 25, 2025: refuse-to-file for the papillary application
• ImmunityBio 8-K, Exhibit 99.1, May 12, 2025: first quarter 2025, permanent J-code
• ImmunityBio 8-K, Exhibit 99.1, March 3, 2025: fourth quarter 2024, expanded access to an alternative BCG
• ImmunityBio 8-K, May 11, 2023: complete response letter
• Quarterly revenue: ImmunityBio earnings releases (8-K) of August 5, 2025, November 5, 2025 and January 15, 2026
• FDA approval notice, September 9, 2025: Inlexzo; Daneshmand et al., J Clin Oncol 2025: SunRISe-1
• FDA approval notice, May 28, 2026: Imfinzi plus BCG in BCG-naive NMIBC
• CG Oncology 10-Q for the quarter ended June 30, 2026; enGene 8-Ks of May 7, 2026 and September 8, 2026
• CMS Medicare Part B payment limit files, October 2026
• SEER Cancer Stat Facts: bladder cancer, 2026 estimate; NCI PDQ: bladder cancer treatment
• Gotto et al., Can Urol Assoc J 2025; Kennedy-Yoon et al., Urology 2026; Jazayeri et al., Eur Urol Focus 2026; Broughton et al., BMC Urol 2022
• GLOBOCAN 2024: European Union fact sheet
• ClinicalTrials.gov: NCT03022825, NCT02138734, NCT07551544, NCT05096663, NCT06745908; Lung-MAP S1800D abstract, J Clin Oncol 42(16_suppl):2619, 2024

Sources read October 15, 2026. Prices are BioRadar daily closes through October 14, 2026. Market estimates are our own illustrative arithmetic from the sources above. This article is for information only and is not investment advice. The author held no IBRX shares when this was written.

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