Yardhawk retweeted
Wainwright predicts $3.5 billion to $4 billion in sales for $IBRX by 2030
The market concensus predicts 6.7 billion in revenue for $MRNA by 2030
This means IBRX trades at roughly 2x sales, while
MRNA trades at 14x sales.
They are different companies, but the math is comparable. Should i tag allan firestein?
Yardhawk retweeted
$IBRX Never in my decades following Biotech have I seen a Biotech selloff 20% after an early FDA Approval that increases the treatable Patient population by 4 times minimum. In fact, the investor expectation was a likelihood of the FDA playing more games to delay approval once again.
The pressure on the FDA and Administration is still directed to All Cancer Lymphopenia and a growing waitlist. Friday’s stratified NSCLC results will support ‘All Cancer’ Approval.
There are not many cancer drugs where response is 100% measurable, by rise in ALC back to normal levels. Treating ‘Failed CPI Patients’ still stacks the deck against ImmunityBio, but results speak for themselves.
Yardhawk retweeted
$IBRX Paradigm shifts! The FDA's accelerated rectal cancer approval sets a massive precedent, positioning ImmunityBio’s ANKTIVA to be next for lung and pancreatic cancer.
By fast-tracking an immunotherapy that helps patients completely avoid chemo, radiation, and surgery, the FDA has signaled a historic priority shift toward toxic-free organ preservation. This regulatory blueprint perfectly aligns with ANKTIVA's multi-tumor pipeline:
•Pancreatic Cancer: ANKTIVA already holds FDA RMAT Designation for advanced pancreatic cancer, aligning with this expedited path.
•Lung Cancer: The platform has already achieved international accelerated approval for metastatic non-small cell lung cancer (NSCLC).
•Organ Preservation: Mirroring the rectal cancer surgery-avoidance goal, ANKTIVA is already validated by an 84% 3-year bladder preservation rate.
The FDA is aggressively clearing paths for immunotherapies that replace radical surgeries. ANKTIVA is next in line. @LoriMills4CA42 @DrPatrick
FDA has granted accelerated approval of an immunotherapy for adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are dMMR or MSI-H.
In a phase 2 study, almost three-fourths of patients did not need surgery, radiotherapy, or chemotherapy after a median follow-up of more than 2 years. For eligible patients, treatment may help avoid chemotherapy, radiation and surgery and their lasting effects.
This is the 11th approval under the Commissioner’s National Priority Voucher pilot program.
Yardhawk retweeted
Cervical cancer. Breast cancer. Ovarian cancer. Current standards of care are painful chemo and radiation. Perhaps this is the beginning of the change !
“This is a transformative moment for women in America. Beginning today, we will change the reality of women’s health.
Previous generations fought for women's rights. Our generation will fight to discover the cures that will ensure a woman can live her lifein health and to the fullest.”
– First Lady Melania Trump
Yardhawk retweeted
$IBRX Hope is rising!
Thank you, @SecKennedy and the Trump administration, for cutting the delays and costs that keep breakthroughs from patients. Through ARPA-H, trials are getting faster, lighter on patients, and better at moving effective treatments forward sooner.
For everyone waiting on #ANKTIVA (an immune therapy) built to fight cancer with less toxicity, this means real progress. Evidence can come quicker, access can expand, and the day more patients receive this kind of care can arrive sooner.
You are not waiting alone. Better options are moving closer. @LoriMills4CA42 @DrPatrick
America should lead the world in turning medical breakthroughs into treatments for patients.
HHS is cutting the delays, duplication, and unnecessary costs that hold clinical trials back. Through @ARPA_H, we are building a modern clinical trial system that generates rigorous evidence faster, reduces the burden on patients, and moves effective treatments from discovery to patients sooner.
Yardhawk retweeted
Journal of Urology publication of our updated 100 patients with long-term data in BCG unresponsive non muscle invasive bladder cancer. Responses extending beyond 53 months! 84% cystectomy free survival at 36 months.
NK cells matters. Chemotherapy reduces lymphocytes.
Next, BCG naive in non muscle invasive bladder cancer.
businesswire.com/news/home/2…
Yardhawk retweeted
New Phase 3 data published in the @JUrology highlights long‑term durability findings from our QUILT‑3.032 study evaluating ANKTIVA® plus BCG in patients with BCG‑unresponsive #NMIBC, with 84% cystectomy‑free survival at three years and complete responses extending beyond 53 months.
Read the full press release: immunitybio.com/immunitybio-…
Yardhawk retweeted
Journal of Urology publication of our updated 100 patients with long-term data in BCG unresponsive non muscle invasive bladder cancer. Responses extending beyond 53 months! 84% cystectomy free survival at 36 months.
NK cells matters. Chemotherapy reduces lymphocytes.
Next, BCG naive in non muscle invasive bladder cancer.
businesswire.com/news/home/2…
Yardhawk retweeted
$IBRX The genius of Dr Soon-Shiong. Not many small biotechs go out the gate with Approval in 34 Countries.
7 of Top 10 markets already approved! Japan, Turkey Soon!
Yardhawk retweeted
Early on when my mom was diagnosed with stage IV pancreatic cancer last year, I envisioned that she could receive an experimental drug that I believe is on the cutting edge of cancer science: ANKTIVA. Yesterday, that vision became reality.
#ANKTIVA is a safe shot (FDA approved only for non-invasive bladder cancer) that, in simple terms, creates more of the body’s own immune cells that kill cancer, while also making them more effective and potentially longer-lasting. These cells are known as NK and Killer T cells, which contribute to a biomarker called ALC (absolute lymphocyte count). Importantly, studies have shown that lower ALC is linked to lower patient survival and ability to overcome cancer. This is why I believe ANKTIVA has the chance to become a really important tool in toolkit against fighting cancer as it increases a patient’s ALC so they have the cells needed to kill cancer, and perhaps it could even be a cancer prevention tool.
My mom was able to receive ANKTIVA through compassionate use, which I highly respect @DrPatrick Soon-Shiong and his company, @ImmunityBio, for offering cancer patients as it honors the spirit and principle of a patient’s Right to Try! Additionally, my mom’s superstar oncologist works as a PI for the company’s clinical trials, which is what strongly motivated me to get her to become my mom’s doctor, has done an amazing job treating my mom.
Adding in ANKTIVA into her treatment plan is going to be incredibly interesting to follow as she is already on an immunotherapy called Keytruda, which could be thought of as taking the brakes off the immune cells that kill cancer. It’s like when someone’s in a fight and the person holding him back decides to let go and let them have at it. And an analogy to think of ANKTIVA and Keytruda working together could be described as turning a sniper rifle into a machine gun (Keytruda), and having a replenishment of supercharged bullets to keep firing (ANKTIVA).
I am still going the distance with my mom until we ring the bell of victory!
🤖 Made with AI
Yardhawk retweeted
$IBRX Adam Fraudstien’s take that ImmunityBio’s papillary NMIBC approval “means nothing” because J&J does more revenue is shortsighted.
IBRX is still early. J&J is a mature company with a massive sales force and decades of market presence. That’s not a fair comparison—it’s like criticizing a growing biotech for not matching a Big Pharma giant on day one.
ANKTIVA is already taking share in the BCG-unresponsive setting. Once the BCG-naïve indication is approved, J&J’s BCG franchise faces real pressure. And this is still just one indication. The upside expands significantly with additional approvals, including lymphopenia and other solid tumor settings.
Revenue today reflects where each company is in its lifecycle. The trajectory is what matters. @LoriMills4CA42 @DrPatrick
Yardhawk retweeted
We are pleased to announce that the U.S. Food and Drug Administration (@FDA) has expanded the indication for ANKTIVA® (nogapendekin alfa inbakicept‑pmln) + BCG to include patients with BCG‑unresponsive non‑muscle‑invasive bladder cancer (NMIBC) with papillary‑only tumors.
This milestone makes ANKTIVA + BCG the first FDA‑approved therapy for both CIS and papillary‑only disease in the BCG‑unresponsive NMIBC setting. Because papillary tumors represent approximately 85 % of NMIBC diagnoses, this approval significantly broadens access to a bladder‑sparing option for patients who face high risk of recurrence and progression.
Read more: immunitybio.com/fda-expands-…
Yardhawk retweeted
Thank you to @FDADrugs for making ANKTIVA accessible to all patients in non muscle invasive bladder cancer who failed BCG therapy. @ImmunityBio - The first treatment approved for this group of patients.
An important step for cancer immunotherapy 2.0.
Big news for bladder cancer patients! FDA just expanded approval of Anktiva with BCG for adults with BCG-unresponsive, high-grade papillary-only NMIBC — the first treatment approved for this group. This is a first, and that matters. Evidence from a closely related form of bladder cancer supported the approval.
fda.gov/drugs/resources-info…
Yardhawk retweeted
$IBRX It has been apparent that Dr PSS has been holding back on announcing agreements. I'm anticipating a string of announcements starting next week, if not tomorrow, given those signatures are likely now finally getting signed. It seems as though he was given the approval nod early, as promised, if he kept a low profile. Things should pick up from here, with new PRs.
$IBRX Effectively doubling the TAM with one approval.
Dramatically Expanded Target Audience: High-grade papillary disease accounts for roughly 50% of all non-muscle invasive bladder cancer (NMIBC) presentations, effectively doubling ImmunityBio’s addressable patient pool within the BCG-unresponsive segment.
Yardhawk retweeted
Thanks to FDA for approving the platform that stimulates NK and Killer T cells. Memory T cells and durable responses is the next evolution of immunotherapy.
We are pleased to announce that the U.S. Food and Drug Administration (@FDA) has expanded the indication for ANKTIVA® (nogapendekin alfa inbakicept‑pmln) + BCG to include patients with BCG‑unresponsive non‑muscle‑invasive bladder cancer (NMIBC) with papillary‑only tumors.
This milestone makes ANKTIVA + BCG the first FDA‑approved therapy for both CIS and papillary‑only disease in the BCG‑unresponsive NMIBC setting. Because papillary tumors represent approximately 85 % of NMIBC diagnoses, this approval significantly broadens access to a bladder‑sparing option for patients who face high risk of recurrence and progression.
Read more: immunitybio.com/fda-expands-…
Yardhawk retweeted
Looking forward to discussing our status of treating non-muscle invasive bladder cancer on Friday
It's time !! $IBRX
ANKTIVA activates IL-15 signaling, expanding & activating NK and CD8+ T cells critical to fighting CA.
EPOGEN: Red blood cells.
NEUPOGEN: Neutrophils.
ANKTIVA: NK & CD8+ T cells.
$IBRX In 1989, Amgen introduced EPOGEN, stimulating red blood cell production. In 1991, NEUPOGEN followed, stimulating neutrophils & protecting chemotherapy patients from life-threatening infections.
Both revolutionized medicine by stimulating specific blood-cell lineages.
More than 3 decades later, ImmunityBio's ANKTIVA (FDA-approved 2024) may represent the next chapter.
ANKTIVA activates IL-15 signaling, expanding & activating NK and CD8+ T cells critical to fighting CA.
EPOGEN: Red blood cells.
NEUPOGEN: Neutrophils.
ANKTIVA: NK & CD8+ T cells.
Different cell lineages, same fundamental principle: harnessing the body's own cellular machinery.
We've spent decades stimulating blood-cell production. Could IL-15 be the missing link in restoring antitumor immunity?
Perhaps the next great biotech breakthrough isn't simply killing CA cells, but restoring the immune system's ability to fight them.
Yardhawk retweeted
$IBRX
Interim data analyses from the 1L BCG-naive cohort have already shown significant improvements in Complete Response (CR) rates and Duration of Response (DOR) compared to historical control/BCG alone.
Additional unblinded efficacy data and definitive topline updates for the trial are expected as full trial enrollment concludes.
Ibrx stated its objective to submit a B (BLA) expansion for 1L BCG-naive NMIBC based on QUILT-2.005 data target dates by late 2026 / early 2027.
Upcoming Catalyst Watch
Dr. Patrick Soon-Shiong is scheduled for a fireside chat with analyst Ted Tenthoff. Updates regarding enrollment timelines, trial readouts, and int'l rollouts are frequently discussed during these events.
1L NSCLC (Lung Cancer): ImmunityBio continues to evaluate Anktiva in combination trials (such as QUILT-2.023) across first-line and checkpoint inhibitor-resistant non-small cell lung cancer, with presentation updates scheduled at major oncology conferences throughout late 2026.






























