Founder Patrick Soon-Shiong has signaled a trial-status discussion at Friday’s Piper Sandler fireside chat.
- The FDA expanded approval for Anktiva, adding BCG-unresponsive papillary-only bladder cancer.
- The decision arrived about three months before the FDA’s Jan. 6, 2027, target date.
- Investors are watching QUILT-2.005, which studies Anktiva plus BCG in patients who have not previously received BCG.
Shares of ImmunityBio (IBRX) are on track for a weekly loss even after securing a broader U.S. approval for its flagship immunotherapy drug, Anktiva, on Wednesday. Investors are now turning their attention to founder Patrick Soon-Shiong’s promised trial discussion on Friday.
IBRX stock rose 1% to close at $9.91 on Wednesday but is still down 6% for the week, putting shares on track for their worst weekly run in nearly three months.
Anktiva Scores An Early FDA Win
The FDA expanded Anktiva’s approval to cover adults with BCG-unresponsive non-muscle-invasive bladder cancer who have papillary-only tumors. The drug is given alongside Bacillus Calmette-Guerin (BCG).
The FDA first approved Anktiva in April 2024 for patients with carcinoma in situ, with or without papillary tumors. ImmunityBio said the latest decision makes it the first FDA-approved treatment for papillary-only disease in the BCG-unresponsive setting, expanding the eligible U.S. patient pool. Papillary disease accounts for about 85% of NMIBC cases, according to the company. Soon-Shiong called the decision “An important first step as we develop Immunotherapy 2.0.”
The approval came nearly three months before the FDA’s Jan.6, 2027, target decision date. The National Comprehensive Cancer Network (NCCN) had already added Anktiva plus BCG for papillary-only disease to its guidelines in March, giving the regimen a Category 2A recommendation.
ImmunityBio has also been expanding overseas. Authorization of Anktiva in the UAE in July brought its regulatory footprint to 34 countries and covered both BCG-unresponsive bladder cancer and metastatic non-small cell lung cancer.
ImmunityBio Founder Teases Friday’s Trial Talk
Soon-Shiong will join Piper Sandler analyst Ted Tenthoff for a fireside chat on Friday as part of the firm’s Virtual Oncology Symposium.
“Looking forward to discussing our status of treating non-muscle invasive bladder cancer on Friday,” he said on X. He also hinted at a trial discussion, saying: “Will discuss status of these trials at my fireside chat next week.”
He responded to a user’s post exploring Anktiva’s potential across several cancers, lymphopenia and sepsis. The post estimated annual revenue of $50 billion to $90 billion if the trials succeed, regulators approve the treatments, and adoption follows.
One program investors are watching is QUILT-2.005, which studies Anktiva plus BCG in patients who have not previously received BCG. In August, ImmunityBio said it planned a supplemental application in 2026 for BCG-naive NMIBC with carcinoma in situ, with or without papillary disease.
ImmunityBio’s Broader Cancer-Care Push
Soon-Shiong has also been promoting a more wholesome approach to cancer care. Last week, he outlined bringing imaging, immunotherapy, chemotherapy, and radiation together so doctors could plan treatment more precisely. “That day has arrived thanks to Aetna CVS and our amazing tech/AI team at NantIQ,” he said.
NantIQ is a separate tech business within his NantWorks network. Its Eviti platform checks proposed cancer treatments against clinical evidence and insurers’ policies before care begins. Soon-Shiong also highlighted “Trial Match,” which aims to connect doctors and patients with clinical trials.
Aetna, owned by CVS Health, announced September 17 that it had expanded bundled cancer-care authorizations for eligible Medicaid members, effective Sept. 1. Providers using Eviti in eight states can submit a combined request covering appropriate chemotherapy, immunotherapy, radiation, and related MRI or CT scans.
How Do Retail Traders Feel About IBRX?
On Stocktwits, retail sentiment for IBRX slipped to ‘bearish’ from ‘neutral’ levels a day ago amid a 415% jump in 24-hour message volumes. The ticker’s watcher base has also risen 3% over the past month.
One user called the FDA approval “mostly a formality,” saying that earlier NCCN guideline support had already paved the way for treatment access. Another user said IBRX was “still over-valued, but the fundamentals just strengthened significantly.”
A separate user expressed disappointment with the rally: “Still believe we climb up a couple bucks, but expected so much more. Gut punch.”
Others looked to Soon-Shiong’s appearance for another catalyst. One user suggested analysts might need to raise their price targets again after Friday’s discussion. Another user anticipated updates on first-line bladder cancer and lung cancer programs, calling IBRX a strong buy.
IBRX stock has surged 401% year-to-date.
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