- CEO Richard Adcock said physicians could prescribe Anktiva for papillary bladder cancer if it is added to NCCN treatment guidelines.
- The company recently filed a supplemental biologics license application (sBLA) to expand the drug’s label to papillary disease.
- ImmunityBio is advancing two lung cancer trials, drawing international interest following Saudi Arabia's approval of the therapy for lung cancer.
Shares of ImmunityBio, Inc. (IBRX) rose nearly 2% in overnight trading on Thursday after the company signaled that its bladder cancer therapy, Anktiva, could reach additional patients through off-label use ahead of a potential FDA expansion of approval.
However, IBRX stock has shed nearly 10% so far over the past four sessions, with Thursday’s drop marking its worst session in over a week.
Off-Label Use Possible Before Full Approval
Speaking at the Citizens Life Sciences Conference, CEO Richard Adcock said physicians could begin prescribing Anktiva for papillary bladder cancer even before a formal FDA label expansion if the therapy is added to treatment guidelines, broadening the therapy’s addressable market.
The company has already submitted supporting data to the National Comprehensive Cancer Network (NCCN), whose treatment guidelines are widely followed by physicians and insurers. Inclusion in the guidelines could allow doctors to prescribe Anktiva for papillary disease based on clinical guidance while the company works toward a full FDA label expansion.
Adcock also highlighted a potential regulatory milestone investors should watch in the coming weeks. “I think the ones to really watch for in the next 60 days… is the FDA accepting that filing,” he said, referring to the company’s supplemental biologics license application filed this week to expand the label to papillary bladder cancer. “We didn’t just randomly do that. They invited us to be able to submit to that one.”
Bladder Cancer Data Highlights
Anktiva is currently approved in the U.S. with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors.
Clinical data from the Phase 2/3 Quilt 3.032 study evaluating Anktiva with BCG showed 58.2% of patients remained cancer-free after 12 months, while more than 80% avoided bladder removal surgery over a three-year follow-up period, according to the company. Adcock said the therapy’s durability is a key differentiator in the treatment landscape. “What they all want is duration,” he said. “Your separation is that duration.”
Lung Cancer Trials Draw Global Interest
Beyond bladder cancer, ImmunityBio is also advancing Anktiva in lung cancer. Adcock said the company has two pivotal trials underway in frontline and second-line non-small cell lung cancer, which could lead to broader approvals. “Saudi Arabia, upon reviewing the data, said, ‘We want to be first in the world to announce this,’” he said. He added that other countries have since reached out to discuss potential regulatory pathways.
Global Expansion And Revenue Outlook
Anktiva is currently approved in 33 countries, while the company is expanding commercialization efforts internationally. “The commercial team in the U.S. knows what they're doing. They're growing quarter-over-quarter,” Adcock said. “The European team is just launching.”
He added that expanding indications and global launches could drive revenue growth in the coming years. “In 2026, ImmunityBio will be a very global company,” Adcock said. “But in 2027 you'll start to see substantive revenue coming from those.”
How Did Stocktwits Users React?
On Stocktwits, however, retail sentiment for IBRX was ‘bearish’ amid a 40% decline in message volumes over the past month.
One bullish retail trader believes that IBRX's recent dip is a "coordinated shakeout" ahead of a potential rebound, with bearish wagers "shorting into a brick wall of institutional buy orders."
"While the dip to $7.82 feels heavy, it serves a specific technical purpose: testing the ultimate institutional floor. We closed just below the 200-day Simple Moving Average," the trader said. "This is the buy zone where major funds like Jane Street and Goldman Sachs typically step in to defend the long-term trend."
One user said, “wonder if NCCN gives an early xmas present and not only approves for papillary but also bcg naive. boy, wouldnt that be fun.”
Another user echoed similar comments, saying an approval for BCG-naive “Would be bold, but certainly deserving of such an action, after all the hold back/slow walk patients and this company has endured over the last year or so. “
IBRX stock has surged nearly 300% year-to-date.
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