A lot of words but no clarity on whether the FDA accepted $IBRX sBLA for Anktiva in NMIBC papillary disease. PDUFA date? Also, if cis and papillary are the same disease, then all currently approved treatments for cis should receive approval for papillary. This is not the Anktiva advantage @DrPatrick suggests.
The truth: $IBRX and @DrPatrick paid for an hour of podium time in the exhibition hall of #AUA26. It was an infomercial, not a presentation included in the meeting’s official scientific program. The difference matters.
The cult of $IBRX, purpose built by @DrPatrick through social media and podcasts. His followers aren’t getting a cancer cure, but they have boosted his paper wealth by billions.
@janiesaysyay @bullishbruk @ImmunityBio @LoriMills4CA42 @alc2022 @MartyMakary @DrMakaryFDA I'm very sorry about your mom getting lung cancer, but her Covid booster didn't cause it. And no one at the FDA is slow walking Anktiva. If you want to be mad, be mad at $IBRX and @DrPatrick for not conducting or completing the clinical trials necessary to determine if the drug benefits patients beyond its limited approval in bladder cancer. X posts, podcast and propaganda videos don't count.
7. $IBRX - $6.99 ImmunityBio. Cancer immunotherapy focused on bladder cancer treatment. FDA-approved Anktiva is the first IL-15 superagonist to reach market. Pipeline expanding into other solid tumors. High risk biotech but the commercial launch is underway. https://t.co/pvDobdc3K7
But if I do what this person asks, I would be lying to myself, misleading others and prove myself to be a propagandist rather than someone who tries to be a fair arbiter even when that means calling bullshit. And if I became a $IBRX Anktiva fanboy now, and spent all my time praising @DrPatrick instead of holding him to account, I would lose the confidence of STAT readers and subscribers. No thanks. Show me the data first.
@pdsandiego @LoriMills4CA42 @DrPatrick Merck received SOME of its initial Keytruda approvals by conducting single arm studies in patients with advanced cancers refractory to all currently approved drugs. $IBRX has not done the same. The bar has not shifted or moved. Your favorite company simply doesn't do the work.
For the umpteenth time, these posters have zero relevance to Anktiva unless, or until, $IBRX conducts/completes randomized clinical trials that demonstrate the drug improves outcomes for cancer patients w/ lymphopenia. @LoriMills4CA42 and the rest of you can idolize @DrPatrick and complain endlessly on X about how the FDA won't approve Anktiva for all cancers. It won't matter unless ImmunityBio shows the data, just like any other drug maker is required to do. You are not special. You do not get or deserve some "go to the head of the FDA line."
@InvestyMan Great add on mate. I have $IBRX on my watchlist 👊
Growth stocks I'm watching right now: $IREN | $48.18 - AI data center infrastructure, 4.5 GW pipeline, largest single-site build in the US $CRDO | $164.09 - AI connectivity, 1.6T optical DSPs in 3nm, just acquired DustPhotonics for $750M $AEHR | $84.49 - AI chip testing, TAM expanding 3-5x beyond SiC into GaN and silicon photonics $HIMS | $27.12 - Telehealth + owned pharmacy network, licensed care model that's hard to replicate $ZETA | $17.87 - AI-powered marketing platform, 56% off its all-time high $OUST | $24.41 - Digital LiDAR on a silicon chip, SAFE LiDAR Act is a policy tailwind $OSS | $9.95 - Ruggedized edge AI compute, guiding 20-25% revenue growth, new energy node contracts $IBRX | $7.31 - ANKTIVA immunotherapy, $44M Q1 revenue, EU conditional approval in Feb
FDA saying, this is exactly why we issued the warning letter to $IBRX.
Every industry has an incumbent that stopped innovating. These companies are coming for their lunch: $HOOD - brokerage $SOFI - banking $OSCR - health insurance $PLTR - enterprise software $NBIS - data centers $TSLA - autonomous vehicles $RKLB - space launch $ASTS - satellite internet $DOCN - cloud infrastructure $ZETA - marketing technology $IBRX - cancer treatment $LEU - nuclear fuel $OSS - edge AI computing $IREN - AI infrastructure $AMPX - battery technology $ONDS - drones and defense $AMZN - everything Who am I missing?
Truly nothing better or more hilarious than Sean Spicer posting false and misleading claims about $IBRX Anktiva while promoting a grifter miracle powder supplement at the same time.
Today's $RVMD study outcome in pancreatic cancer is a good lesson for all the $IBRX @DrPatrick fans. Stop with all the hand-waving "cancer cure" podcasting social media nonsense. Shut up and run well-designed clinical trials with definitive endpoints. If you have a drug that truly helps patients, the data will speak loudly for you.
10 Stocks That Have Nearly DOUBLED in 2026 YTD. While the market bleeds, these names are printing $SNDK Pure-play NAND flash powerhouse spun off from Western Digital. Revenue up 61% YoY driven by AI data center demand. Joining Nasdaq-100 on April 20. The AI memory supercycle is real. $AXTI Makes indium phosphide substrates — the critical material powering silicon photonics. Plans to double manufacturing capacity in 2026. Every AI data center needs what they make. $AAOI Optical transceiver maker riding the hyperscaler buildout wave. Direct picks-and-shovels play on AI fiber infrastructure. Revenue exploding as data centers scale. 💡 $IBRX Anktiva bladder cancer drug revenue up 168% YoY. Now approved across 34 countries with FDA label expansion pending. From clinical-stage to commercial inflection — fast. 💊 $AEHR Wafer-level burn-in testing leader for silicon carbide and photonics chips. Picks-and-shovels for the semiconductor ramp no one talks about. Quietly one of 2026’s best setups. $SATL Geospatial intelligence + DoD contract momentum driving this space stock. Defense and surveillance demand exploding globally. Under the radar but not for long. $LITE Pure-play photonics and optical components powerhouse. Direct supplier to hyperscalers building out AI data center interconnects at massive scale. Transceiver and laser demand exploding as cloud providers race to upgrade optical infrastructure. Revenue recovering strongly after a multi-year downcycle — the comeback trade in photonics. The “layer below the chips” thesis made into a stock. $OPTX Optical component supplier benefiting from photonics buildout AND defense optics demand. Dual catalyst — AI infrastructure + government contracts. Tiny float, big moves. $LWLG Electro-optic polymer company powering next-gen silicon photonics modulators for AI data centers. Signed a deal with Tower Semiconductor targeting 400G per lane optical modules. A Fortune Global 500 company now in Stage 3 of their design win cycle. Pre-revenue but catalysts stacking fast. $NBIS European AI hyperscaler projecting revenue run rate to grow from $1.25B to $7-9B by end of 2026. GPU cloud infrastructure at scale. Think AWS but built purely for AI workloads. ☁️
I just closed 6 cash-secured put trades for an average annualized return of 144%. Average trade length: 16 days. The puts were sold on: $SOFI $IBRX $HOOD $ZETA $BMNR $XSP/ $SPX Here is everything you need to know about cash-secured puts: What it is: You sell a put option on a stock you'd be happy to own. You collect premium upfront. If the stock stays above your strike, you keep the money. If it drops below, you buy shares at a price you already wanted. How I set them up: - Stock on my watchlist that I'd own for years - ~0.20 delta (~80% chance of keeping premium) - 30 DTE to capture the steepest theta decay - Strike at or below a key support level - High IV environment so premiums are worth the risk - Tight bid-ask spreads and strong open interest The rules: - Close at 50% profit and redeploy. Don't hold to expiration. - Never sell into earnings, CPI, or Fed days - Never sell on stocks you don't actually want to own - Never sell when IV is low and premiums are thin Three outcomes every time: 1. Stock stays above your strike You keep the premium. Rinse and repeat. 2. Stock drops but thesis is intact Roll the put down and out. Collect more premium. Wait at a better price. 3. You get assigned You buy a stock you wanted at a discount. Start selling covered calls. That's the wheel. What most people get wrong: - Chasing fat premiums on stocks they haven't researched - Selling into binary events because the premium looks good - No exit plan before they enter - Oversizing because they're excited, not because the math supports it The annualized math is what makes this work. Collecting 3-5% on capital in 10-16 days and redeploying compounds faster than most people realize. This is the core of my system. CSPs and covered calls are the engine. LEAPs are the selective add-on. Long-term equity holdings are the foundation. NFA DYOR
I'm only going to say this once. These 12 stocks have the potential to create millionaires by 2028: $NVDA at $175 → Avg PT $266 (+52%) $AMZN at $212 → Avg PT $281 (+33%) $IREN at $34 → Avg PT $65 (+91%) $RKLB at $67 → Avg PT $88 (+31%) $ONDS at $9.35 → Avg PT $20 (+114%) $SOFI at $16 → Avg PT $25 (+56%) $HIMS at $19.87 → Avg PT $40 (+101%) $SYNA at $73 → Avg PT $101 (+38%) $ZETA at $15.69 → Avg PT $29 (+85%) $UUUU at $17.65 → Avg PT $27 (+53%) $IBRX at $6.95 → Avg PT $14 (+101%) 7 sectors. AI, defense, space, fintech, healthcare, energy, and critical minerals. Every analyst target on this list represents significant upside from current prices. The market is giving you a window. NFA DYOR
2. $IBRX at $7.13 - Biotech/Immunotherapy ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer. Full-year 2025 revenue hit $113M, up 700% YoY. Q4 alone was $38.3M. Now approved in 33 countries. Expanding into lung cancer with a BLA filing targeted by Q4 2026. Randomized trial showed 84% complete response rate vs 52% for standard treatment. This is a real drug with real revenue in a space that desperately needs better options.
These 10 stocks have the potential to create millionaires by 2028: $NVDA - AI Compute $AMZN - Cloud/E-Commerce $IREN - AI Infrastructure $HOOD - Fintech $ZETA - AI Marketing $ONDS - Defense/Drones $SOFI - Digital Banking $RKLB - Space $IBRX - Biotech $NBIS - Cloud Computing Bookmark this and come back in two years.
And the bullshit press releases from $IBRX mount up! What's it going to be tomorrow? Pat confirms he's had a nice breakfast and is ready for the day?
@DrPatrick Hey @DrPatrick - I was told by one of the QUILT 2.005 investigators that $IBRX restricted enrollment to BCG-naive NMIBC + CIS, a more narrow disease indication than you and Adcock have suggested in your public comments. $IBRX shut down Cohort B of this study, which was enrolling patients without CIS, more in line with the broader BCG naive indication your competitors are pursuing. Can you comment, please?
FDA slams Soon-Shiong @DrPatrick and ImmunityBio $IBRX for making ‘false and misleading’ claims about a drug https://t.co/MNcmA49i33 via @pharmalot
My Q2 2026 watchlist: $AMZN - AWS powering OpenAI + Anthropic. $200B capex this year. AI infrastructure backbone. $IREN - $9.7B Microsoft contract ramping. 150K GPUs deploying. Cheapest neocloud. $NBIS - AI cloud scaling fast. NVIDIA $2B investment. Revenue growing 500%+ YoY. $ZETA - 18 consecutive beat-and-raises. $1.76B revenue guide. AI marketing leader. $SOFI - $1B quarterly revenue. CEO buying $1M in stock. Full financial ecosystem. $ONDS - Defense/drone demand accelerating. 6x revenue growth. $170M+ 2026 target. $SYNA - Edge AI chips. Core IoT revenue up 53%. New management driving turnaround. $IBRX - Biotech with FDA catalysts ahead. High risk, high reward. $OSS - Edge computing for AI at the source. Small but positioned in a massive market. $TE - Energy storage demand growing with data center and grid buildout. $MP - Only scaled rare earth mining and processing operation in the Western Hemisphere. Critical supply chain play. 11 names across AI, defense, fintech, biotech, energy, and materials. Not all of them will work. But I believe the winners will more than make up for the losers.
Recall, I wrote previously about how $IBRX and @DrPatrick misrepresented results from Anktiva's bladder cancer trials and his interactions with FDA officials. Today's warning letter further confirms my reporting. https://t.co/asmPSdLaYF
FDA issued a warning letter to $IBRX about "false and misleading" statements regarding Anktiva made by @DrPatrick on the Sean Spicer TV show. https://t.co/X9FEBPsDQA h/t @AlecGaffney for spotting first.
I'm 34 years old and a self-made millionaire. My March advice: $NVDA (NVIDIA) - Strong Buy $AMZN (Amazon) - Strong Buy $IREN (IREN Limited) - Buy $HOOD (Robinhood) - Strong Buy $ZETA (Zeta Global) - Strong Buy $RKLB (Rocket Lab) - Hold $ONDS (Ondas Holdings) - Buy $SOFI (SoFi Technologies) - Strong Buy $PATH (UiPath) - Buy $SYNA (Synaptics) - Strong Buy $IBRX (ImmunityBio) - Buy $HIMS (Hims & Hers) - Buy $PANW (Palo Alto Networks) - Buy $TSLA (Tesla) - Hold I hope this helps someone out there build generational wealth. That's what this is all about. NFA DYOR
The $RLMD bladder cancer data (phase 2) reported this morning look very good. Another competitive blow to $IBRX particularly at its bloated valuation. https://t.co/wYThfwIpG8
Weekend is a great time to do some research. Companies I’m going to look into this weekend: $IBRX $AAOI $UAMY $LITE $POET $TE $AMPX Here is my method 👇
Th FDA is absolutely correct, and confirms what I’ve said all along. This $IBRX @DrPatrick “lymphopenia” push means nothing until or unless they come up with real data showing patient benefit. The “number” doesn’t matter.
$IBRX $12B market cap, on par w $BMRN, just behind $BBIO $NBIX and larger than $JAZZ $MDGL Your 2026 biotech meme stock...
@oshea9_harry @IdenixH @pdsandiego Nothing you state here changes the regulatory requirements that $IBRX cannot meet.
@Rajesh_198911 @IdenixH @Adam1996Indep Then $IBRX should file. It will be rejected.
@Adam1996Indep $IBRX needs to demonstrate reversal of lymphopenia leads to a clinical outcome (benefit) for patients. Epogen treats anemia, but it was approved first in chronic kidney disease because it led to reductions in red blood cell transfusions. Similarly, Neupogen boosts neutrophils (white blood cells) but it was approved because it reduces the risk of serious infections.
Reversal of lymphopenia is not an acceptable endpoint for Anktiva FDA approval. $IBRX could file but if it did, the application would be rejected.
@aakashgupta Aakash - Thank you for framing the bull-bear debate over $IBRX in more realistic terms. You don't quite have the short thesis correct. Sales growth in 2025 was impressive, but not surprising given the early launch trajectory, and the rate of growth will slow. New approvals won't be coming every few weeks. Approvals are now stalled bc ImmunityBio doesn't have data from clinical trials required to expand the use of Anktiva beyond its niche in-situ bladder cancer indication. The Middle East efforts are largely performative. The US and Europe matter. Selling drugs in Europe is challenging, from pricing and access perspective. The company also faces formidable competition, mostly from J&J's bladder cancer drug Inlexzo. At a $9B EV, ImmunityBio trades at 48 times forward sales. It's overvalued. And as you point out, the company is not profitable. Cash TBD. I suspect the company has been selling a lot of stock since the beginning of the year, taking advantage of the recent surge in its stock price. The short interest is sky high, as you noted. ImmunityBio is a weird stock in that there are 1B shares out, 70% of which are owned/controlled by Patrick Soon-Shiong. That makes it a very dangerous short, especially with the stock achieving meme status, illustrated quite well by the post from "Tank Sinatra."
Look at $IBRX today! Anktiva was approved in Europe for "in situ" bladder cancer, the same indication already approved in the US. Today news, not a surprise. The CHMP positive opinion was issued in December. How is ImmunityBio going to sell Anktiva in Europe? Unclear. Last November, CEO Rich Adcock, speaking at the Jefferies conference, said the company was speaking to potential commercialization partners. Nothing announced yet.
“Adam, you’re such a shorty loser. You’re obsessed with $IBRX!” — X accounts that post 24x7 about $IBRX This is always my favorite.
This is not a Saudi-USA Biotech Alliance, it’s a Saudi @DrPatrick $IBRX “you pay we pay” marketing campaign. Anktiva is stalled in the US because he can’t generate the clinical data to move the drug forward, so he goes to the Middle East where standards are more transactional than science based.
@pdsandiego @DrPatrick Merck's initial approval in the MSI-H/dmmr pathway was conducted in patients with refractory disease. It has since conducted RCTs in newly diagnosed patients. Example: https://t.co/QK2wGYgmlR $IBRX obtained its Anktiva CIS bladder approval via a single-arm study.
It would be highly instructive to read the pembrolizumab paper highlighted by @DrPatrick. Of course, he doesn't expect anyone to do that. This is what it says IN THE FIRST PARAGRAPH: The FDA approved pembrolizumab on May 23, 2017, for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and for the treatment of unresectable or metastatic MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The FDA granted the approval based on an understanding of the biology of MSI-H/dMMR across different tumors along with the clinically important effects on overall response rate (ORR) observed in patients who were enrolled in 1 of 5 single-arm clinical trials. None of these elements of the pembro approval pertain to $IBRX Anktiva at all. If Dr. Soon-Shiong wants the FDA to broaden the use of Anktiva beyond its niche approval in a type of bladder cancer, I strongly suggest completing clinical trials. Collect real evidence the drug is effective, and then maybe the FDA will do what he wants.
@pdsandiego Incorrect. $IBRX has run afoul of the FDA bc it didn't follow the agency's clearly stated guidance for papillary bladder cancer. The FDA didn't move the goalpost, @DrPatrick decided the goalpost didn't matter.
@salc7822 @DrPatrick I do. The Saudi strategy is intended to divert attention away from $IBRX regularly failures here and delays in completing clinical trials.
@salc7822 @DrPatrick Ah! Clinical trial results that demonstrate a benefit would be helpful. Do you see $IBRX completing any of its studies in the near term?
How does $IBRX benefit from the Saudi FDA approval of Anktiva? What say the fanboys/girls of @DrPatrick on this question? I'm not talking about the stock price, so spare me that reply. What material benefit will ImmunityBio gain from focusing on Saudi Arabia?
Finally? @DrPatrick $IBRX needs to freshen up his cell therapy knowledge. This Lilly-Orna deal is the fourth acquisition of an in vivo CAR-T developer by a large drug maker, behind Bristol, Abbvie and Gilead Sciences. Notable, none of these acquisitions focus on NK cell therapies. Why? Because NK cell therapies have been studied already - and they don't work!
@Sanctuary_Bio @alc2022 Same idiot touting $IBRX will save the world.
@GuywithUmbrella Autologous CAR-Ts: Gilead's Yescarta and Bristol's Breyanzi. Both are approved, with survival benefits, across different lymphoma indications. Allogeneic (off the shelf) CAR-Ts: Still experimental, but both Allogene and Caribou have more and better data than anything that $IBRX has shown to date.
@biotraderusa Reporting n=4 is highly misleading, but that's what $IBRX chose to do.
@pdsandiego Correct. Those benchmarks include conditioning, but a $IBRX non-conditioning regimen with suboptimal remission rates will be a non-starter.
$IBRX NK cell therapy showing 50% durable CR rate in indolent NHL (and just WM) is suboptimal, lower than competing allogeneic and autologous CAR-Ts.
@bullishbruk I didnt post publish a story on $IBRX today.
@IdenixH @bullishbruk Then you should push $IBRX to submit a BLA.
Show of hands, how many $IBRX @DrPatrick acolytes on this platform are antisemites? Be honest, most of you basement-dwelling cowards post anonymously, anyway.
@IdenixH @bullishbruk Yes. That was nearly one year ago. $IBRX has stopped talking about seeking approval for a lymphopenia indication because simply reversing it is not an FDA-accepted outcome to support approval. The company will need to run trials showing that reversing lymphopenia (however that is characterized) leads to a “real” outcome, likely overall survival. Good luck with that!
@seahorse_anton @DrPatrick Incorrect. The FDA will decide whether or not to approve $IBRX Anktiva for papillary bladder cancer based on the current data. That is what matters.
@aiApotheosis @Jeromepowwpoww @DrPatrick I have not falsified information at any time, anywhere. I do not invest in individual stocks. I don’t have a short position in $IBRX or any stocks.
$IBRX ImmunityBio’s Soon-Shiong mischaracterized talks with FDA over cancer drug, sources say The company had expressed shock at the agency’s response to its submission https://t.co/asmPSdLaYF
In this week's Biotech Scorecard newsletter: $IBRX ImmunityBio and its Chairman Patrick Soon-Shiong @DrPatrick mischaracterized talks with FDA over expanding use of Anktiva, its bladder cancer drug, sources told me. Publicly, $IBRX and Soon-Shiong have claimed the FDA “unanimously” endorsed the Anktiva data after a January 2025 meeting, and “unambiguously invited” the company to file an application for the papillary bladder cancer indication. I spoke to people familiar with the FDA involvement in this January 2025 meeting. They told me: At no point during or after the January 2025 meeting with ImmunityBio did anyone at the FDA endorse the Anktiva data, nor did anyone suggest that a submission would be accepted and reviewed, people with knowledge of the FDA’s side of this story told me. They requested anonymity to discuss sensitive information that the FDA can’t disclose publicly. Soon-Shiong’s public statements, both last year and more recently, have been “misrepresenting” what actually happened at this meeting and what was said, one person told me. Full story link below, including more details about Soon-Shiong highly unusual lobbying of Trump officials.
$IBRX meme stock confirmation.
@hema_Toma @DrPatrick The participants in $IBRX GBM study are not “when all else failed.” They have recurrent disease. TTF is approved in this setting, as is bevacizumab.
Yet, @DrPatrick $IBRX fails to mention that with only 6 months of median follow up in these recurrent GBM patients, making any claim about extended survival is nonsense, especially when TTF therapy in these patients is proven to be modestly effective. (Median OS 6 months) Last August, $IBRX reported response rates from 5 patients in this study. Yesterday’s release with 14 evaluable patients - no disclosure of response results. Selective, inconsistent data releases are a red flag.
@Biohazard3737 Meantime, the value of Patrick Soon Shiong's 69% ownership stake in $IBRX has increased by $3.3B YTD.
@singhlosophy @Sanctuary_Bio $IBRX is becoming the new $NWBO, or is it not quite as bad as that?
The $IBRX Quilt-3.092 CAR-NK study also requires patients to undergo lymphodepleting chemotherapy prior to cell therapy infusion. https://t.co/fPMR7Jhwht
$IBRX Anktiva q/q sales growth slowed, cash balance decreased. How much dilutive cash did the company raise from its adjusted ATM in January? https://t.co/UTKcVOAs4x Classic: Issue lots of press releases, pump stock higher, sell stock.
@SweetStocks22 @bullishbruk @DrPatrick @LoriMills4CA42 this anonymous account who posts nonstop about $IBRX has consistently lied about the reasons for my skepticism. This idea that I'm mad about not interviewing PSS is absurd. I have talked to ImmunityBio several times.
@SweetStocks22 @DrPatrick The glioblastoma data (scant) come from single arm combination trials. None of the data prove Anktiva is having any effect at all. And yes, Anktiva is approved in bladder cancer, but $JNJ recently approved drug is taking significant market share away from $IBRX.
@SweetStocks22 @DrPatrick What does Anktiva "working" mean? Contrary to $IBRX claims, boosting ALC count is not a patient benefit or regulatory outcome recognized by the FDA. The trials are not ill-conceived, @DrPatrick simply doesn't seem to care about completing them before making unsubstantiated claims about Anktiva.
The Saudi FDA approved $IBRX Anktiva in lung cancer based on a discontinued randomized study with inconclusive post-hoc data + a non-randomized study with a made-up nonsense responder analysis. These are the data that @DrPatrick and $IBRX tried to submit to the FDA last year but were told, instead, to run another study. Now we know why Patrick Soon-Shiong has been spending so much time in Saudi Arabia.
@bradloncar @DrPatrick Pat evidently thought he'd get more out of chairing the Saudi summit today. And lo! $IBRX https://t.co/Cu7xCbr3PV
$FATE and several other biotechs studied engineered NK cells targeting cancer. The results were nearly universally disappointing. This $IBRX effort isn’t any different.
I suggest completing one of the many Anktiva clinical trials. Notable that this seemingly important milestone isn’t mentioned. $IBRX
@StephenWangs73 @drpatrick So, $IBRX is giving away Anktiva for free? I’ll have to ask about that. Odd business strategy. How do you think the company is going to win approval for lymphopenia without any benefit for patients?
@SweetStocks22 @drpatrick $IBRX is more than welcome to submit data to the FDA to seek an expanded approval for Anktiva / Bioshield beyond its limited approval for bladder cancer. Earlier this year, the company said it was going to file for a lung cancer approval, then reneged, and is now conducting another clinical trial. Its effort to expand the existing approval in bladder cancer was rejected by the FDA witout a review. Making unsubstantiated claims on X isn't a substitute for clinical data.
For @alc2022 and all the other folks naively buying into the exaggerated medical claims that @drpatrick is making about $IBRX Anktiva Piercing the hype around Dr. Patrick Soon-Shiong's 'Bioshield' cancer treatment Published 9.11.25 Clinical trial results presented earlier this week do not support the claim made by billionaire physician Patrick Soon-Shiong that a drug sold by his company, ImmunityBio, prolonged the lives of patients with advanced lung cancer. The drug, Anktiva, is marketed as a treatment for a type of bladder cancer. Commercial sales are modest, and a competing, potentially superior drug from Johnson & Johnson was approved this week. Anktiva might one day prove beneficial to lung cancer patients, a much larger and more lucrative commercial market, but only if a recently started, randomized Phase 3 clinical trial reads out positively. That’s going to take a few years, as are randomized studies in other tumor types. To claim now that the drug “extends overall survival” — as Soon-Shiong and ImmunityBio stated this week — is an overreach based on questionable data from an uncontrolled study. It also undersells future risks. I’ll get to the red flags in the lung cancer study in a moment, but first, you need some background on Anktiva and how it plays into Soon-Shiong’s vision for a cancer “Bioshield.” ImmunityBio declined my interview requests and did not respond to a list of submitted questions. God, lymphocytes, and the ‘Bioshield’ Soon-Shiong’s theory is that the established practice of cancer care — using drugs and radiation to kill tumors — can be effective in the short term but detrimental to long-term survival. While standard treatments wipe out cancer cells, they also destroy certain types of immune cells, called lymphocytes, that are needed to find and destroy residual cancer cells remaining in the body. When these lymphocytes are depleted, a condition called lymphopenia, cancer cells can escape, regrow into tumors, and shorten a patient’s life. The solution to preventing cancer recurrence, and even curing it altogether, Soon-Shiong believes, is reversing lymphopenia. If one boosts a patient’s lymphocyte count, the strengthened immune system will work on its own to monitor, find, and destroy cancer cells. It just so happens that Soon-Shiong’s biotech company, ImmunityBio, has a drug to achieve this ambitious goal, he has said. Anktiva targets a molecule called IL-15 to stimulate the production of the same type of lymphocytes that he claims are needed to cure cancer. And not just bladder cancer where Anktiva is currently approved, but all types. It’s a potentially transformative idea but also one in which the catchy buzz phrase Soon-Shiong has created — the Bioshield — isn’t yet supported by convincing clinical evidence, including the lung cancer study results presented this week. That hasn’t stopped Soon-Shiong from making exaggerated claims about Anktiva curing cancer during guest appearances on podcasts hosted by the likes of Tucker Carlson, Megyn Kelly, and others. Soon-Shiong describes himself as a selfless scientist who has spent decades and millions of dollars of his own money in the search for a cancer cure to share with the world. Lymphocytes were invented by God 400 million years ago, he told Kelly on a recent episode of her podcast. “This cell exists so that it prevents us from having cancer, it prevents us from dying from infection, from Covid, from sepsis, from bacteria. How to activate this cell with a single jab? That’s what we’ve discovered.” Conveniently left out of the discussion is the fact that Soon-Shiong owns 70% of publicly traded ImmunityBio and the “jab,” Anktiva, is its sole commercial product. The podcast marketing push is also spiked with conspiracy theories claiming interference from Big Pharma and deep state FDA officials — unsubstantiated talk that MAGA audiences lap up. A look at the data This week, ImmunityBio reported data from a Phase 2 study called QUILT 3.055 that enrolled 86 participants with non-small cell lung cancer relapsed after initial treatment with a PD-1/PD-L1 checkpoint inhibitor. All of the study participants received injections of Anktiva and continued treatment with their same checkpoint inhibitor. In a group of patients with lymphocyte counts in a normal or high range, the median overall survival was nearly 16 months compared to 11.5 months for patients with low or reduced lymphocyte counts. Statistically, a higher lymphocyte count was associated with a 58% reduction in the risk of death, the company reported. “These results present the clinical evidence that a low lymphocyte count, as measured by ALC [absolute lymphocyte count] levels, is an actionable, accessible biomarker to identify and treat therapy-induced lymphopenia in cancer patients with Anktiva and prolong overall survival,” said Soon-Shiong, in a statement. The Anktiva data was presented at the World Conference on Lung Cancer, held this week in Barcelona. Some red flags to consider: -- The study was not randomized and didn’t include a true comparator arm. ImmunityBio presented survival from two groups of patients who received the exact same treatment — Anktiva plus a checkpoint inhibitor. -- The study was not prospectively designed to measure lymphocyte counts, or correlate change in lymphocyte counts with overall survival. The analysis was conducted after the study was completed. -- ImmunityBio also retrospectively defined the level at which lymphocyte counts were considered high/normal or low/reduced. The number in this study was 1,200 cells, but in other studies, the company has set the threshold at 1,000 cells. Unless prospectively defined, the finding is biased. ImmunityBio could simply set the cutoff at whatever level made the survival outcome look best. -- How frequently did patients need to have lymphocyte counts above 1,200 to be included in the better-surviving group, since lymphocyte counts can rise and fall frequently? The study, as presented, doesn’t clarify how lymphocyte counts were measured, or how frequently. ImmunityBio also reported a median overall survival of 14 months for all 86 patients who participated in the study. The standard treatment for lung cancer patients like this is typically a chemotherapy called docetaxel, which has been shown to prolong survival by seven to nine months, according to previously conducted studies cited by the company. That cross-trial comparison puts Anktiva’s survival benefit in a favorable light. However, larger and more current randomized studies have pegged docetaxel’s median overall survival at 11 months — making Anktiva’s result less impressive. None of the Anktiva data are conclusive. Last January, ImmunityBio told investors that it would be seeking FDA approval to expand the use of Anktiva to treat lung cancer patients based on the QUILT 3.055 study results. More recently, the company pulled the guidance for reasons it hasn’t disclosed. The FDA’s refusal to consider non-randomized data sufficient for approval is a good bet. I wouldn’t rule out the possibility that Anktiva, by raising lymphocyte counts, prolongs cancer survival. Maybe it’s the cure that Soon-Shiong promises. But instead of just talking about it, let’s see the clinical data that prove it.
@JBluePolaski_ Quilt 2.005 could potentially expand use of Anktiva in bladder cancer. The FDA rebuffed $IBRX earlier attempt when it issued the refuse-to-file letter. Will the company require data from the randomized portion of 2.005 in order to refile?
@MAugusterfer Thank you. Anktiva is an approved drug, so doctors can prescribe it off label if they believe it will help their patients with other types of cancer. $IBRX and @drpatrick won't admit it, but this might be the agenda behind all the podcast appearances, particularly with competition in bladder cancer arriving. Insurers aren't likely to pay for off label Anktiva, even if doctors want to use it. That's going to be tough. Bottom line: Shortcuts in cancer drug development are hard. But $IBRX is starting to run randomized studies of Anktiva. The results will tell the tale.
@JBluePolaski_ The burden for $IBRX is to prove Anktiva improves outcomes for cancer patients — hopefully by prolonging survival. It is not enough to show the drug improves or prevents lymphopenia. This is why, for instance, the Ph3 study in lung cancer, recently started, has improvement in OS as the primary goal. The primary goal is not "increase in lymphocyte count."
I wouldn’t rule out the possibility that Anktiva, by raising lymphocyte counts, prolongs cancer survival. Maybe it’s the cancer cure that Soon-Shiong promises. But instead of just talking about it, let’s see the clinical data that prove it. $IBRX https://t.co/rqqj6zG0rB
This week's Biotech Scorecard newsletter: Piercing the hype around Patrick Soon-Shiong’s ‘Bioshield’ cancer treatment Clinical trial results presented earlier this week do not support the claim made by @drpatrick that Anktiva, a drug sold by his company, ImmunityBio $IBRX, prolonged the lives of patients with advanced lung cancer. Read more about the red flags in the Anktiva lung cancer study. Also, background on how Anktiva plays into Soon-Shiong's vision for a cancer“Bioshield.” Story link below.
@drpatrick Dr. Soon-Shiong — Can you please post the WCLC poster on the $IBRX website?
@DavidDin @ImmunityBio This $IBRX lung cancer trial is not new. Results were reported last year, in fact at the same lung cancer conference last year. This weekend's presentation is a different analysis of previously reported data.
@WealthWithRG What would an $IBRX FDA label for lymphopenia look like? I’m unaware of a randomized study that ties ALC to improved patient outcomes. All the data I’ve seen is posthoc, non-randomized. Anktiva may increase ALC but for what benefit?
@drpatrick Dr. Soon-Shiong - Has $IBRX published the full data from the Quilt-3.055 NSCLC study? The presentations I've found are incomplete. Where can we find all the baseline data for study participants, for instance? That information is particularly relevant to better understand the claims you make about higher ALC leading to improved OS.
@Zac_ETHron @bullishbruk @drpatrick $IBRX clinical trials are not unique or unusual in any way.
