The UAE becomes Anktiva’s fifth regulatory jurisdiction, expanding its footprint to 34 countries and boosting ImmunityBio’s global push.
- The UAE granted Anktiva its broadest approval yet across bladder and metastatic lung cancer.
- In the U.S., ImmunityBio is seeking a similar papillary-only label expansion, with an FDA decision due Jan. 6, 2027.
- Trial data showed Anktiva helped 58% of certain bladder cancer patients stay disease-free for a year, while lung cancer patients lived a median 14.6 months.
Shares of ImmunityBio, Inc. (IBRX) rallied nearly 8% overnight late Wednesday after the United Arab Emirates (UAE) granted Anktiva, the company’s cancer immunotherapy, its broadest approval yet across bladder and metastatic lung cancer, delivering on founder Patrick Soon-Shiong’s “July birthday news” promise.
IBRX stock declined 2% in Wednesday’s regular session, extending its losing streak to six days. Shares are also headed for their fourth straight week of losses.
Anktiva Gets Broad UAE Nod
The Emirates Drug Establishment approved Anktiva for two uses: certain bladder cancer patients whose disease no longer responds to standard BCG treatment, including those with papillary-only tumors, and patients with metastatic non-small cell lung cancer whose disease worsened despite standard therapy.
Minutes before the announcement, Soon-Shiong thanked followers for birthday wishes and said on X: “July birthday news coming as predicted. Global expansion unstoppable.” After the approval was disclosed, he called the UAE decision the “broadest indication to date” for Anktiva.
The UAE is the first worldwide to clear Anktiva plus BCG across the full range of BCG-unresponsive non-muscle invasive bladder cancer, covering patients with carcinoma in situ, or CIS, with or without papillary tumors, as well as those with papillary-only disease. The distinction is notable for ImmunityBio as papillary-only disease remains outside Anktiva’s currently approved U.S. indication.
The Food and Drug Administration (FDA) first approved Anktiva in 2024, in combination with BCG, for certain bladder cancer patients whose disease no longer responded to BCG and included carcinoma in situ, or CIS. ImmunityBio is now seeking to broaden its U.S. label to include papillary-only patients.
In May, the FDA agreed to review the company’s application and set Jan. 6, 2027, as the target date for a decision. The acceptance represented a turnaround after the FDA declined to review essentially the same application last year.
ImmunityBio Touts Anktiva Trial Results
ImmunityBio’s case for broader use is backed by its Quilt-3.032 study. Among 80 patients with papillary-only bladder cancer that no longer responded to BCG, 58% remained disease-free after one year, while 83% had avoided bladder-removal surgery at three years. In a separate group of 100 patients with CIS, 71% saw their cancer completely disappear, with some responses lasting more than 54 months.
“For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options,” Soon-Shiong said. The UAE approval also expands Anktiva into lung cancer. The regulator cleared it with checkpoint inhibitors for adults with metastatic non-small cell lung cancer whose disease worsened despite standard treatment, including immunotherapy with or without chemotherapy.
The decision is backed by a Phase 2 study of 79 patients whose cancer had already stopped responding to checkpoint inhibitors. Median survival was 14.6 months, rising to 16.2 months among patients with higher levels of circulating lymphocytes during treatment.
ImmunityBio Pushes Global Expansion
The UAE becomes the fifth regulatory jurisdiction to authorize Anktiva, following the U.S., U.K., Saudi Arabia and European Union, bringing its regulatory footprint to 34 countries. The approval adds momentum to ImmunityBio’s international push even as the company continues navigating regulatory friction in the U.S.
Earlier this year, ImmunityBio launched Anktiva in Saudi Arabia for certain bladder and lung cancer patients as part of its broader Middle East strategy. Soon-Shiong has also signaled potential expansion in markets including Greece and Turkey.
The company has meanwhile been strengthening its U.S. infrastructure, including an exclusive agreement with Japan BCG Laboratory for the Tokyo-172 BCG strain, offering a potential second supply source amid chronic shortages.
How Do Retail Traders Feel About IBRX?
On Stocktwits, retail sentiment for IBRX improved to ‘neutral’ from ‘bearish’ levels a day ago amid ‘normal’ message volume.
One user said, “$IBRX Everyone, the UAE approval makes the imminent earnings drop very interesting. I would look for not only revenue growth, but also for a feel of how much demand there is for Anktiva.”
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Another user sees the UAE approval as a potential regional springboard, citing the country’s healthcare influence, the "full BCG-unresponsive" clearance, potential for "premium pricing" and expectations that Soon-Shiong could have more positive updates coming in "waves."
View this Stocktwits post
IBRX stock has jumped 169% over the past year.
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