IBRX Stock Jumps Overnight After Major FDA Review Win For Anktiva In Bladder Cancer

• The FDA will review the expansion of Anktiva plus BCG to patients with papillary-only bladder cancer, with a final decision expected by Jan.6, 2027.
• The acceptance reversed last year’s FDA refusal-to-file setback for essentially the same application.
• Even amid FDA tensions, ImmunityBio continued expanding globally through Japan BCG supply deals, international approvals and Middle East partnerships.

Shares of ImmunityBio, Inc. (IBRX) jumped 3% overnight heading into Wednesday after the U.S. Food and Drug Administration (FDA) accepted its Anktiva bladder cancer expansion filing, capping off a turbulent stretch marked by a refusal-to-file setback, a warning-letter battle and public disputes with regulators.

IBRX stock declined 3% on Tuesday to end at $7.76. 

ImmunityBio Scores FDA Review Win

The FDA agreed to review ImmunityBio’s application to expand the approved use of Anktiva plus standard BCG into a broader group of bladder cancer patients whose disease no longer responds to standard BCG treatment. The application specifically targets patients with papillary-only bladder cancer, a group ImmunityBio says accounts for about 85% of the 64,000 non-muscle invasive bladder cancer cases diagnosed each year in the U.S. The FDA set Jan.6, 2027, as its target date for a final decision.

The acceptance marks a major turnaround from last year, when the FDA refused to even review the same application despite ImmunityBio saying senior agency officials had previously encouraged the company to submit it based on data from its Quilt-3.032 bladder cancer study. 

Soon-Shiong had publicly challenged the inconsistencies in the FDA’s position, saying that Anktiva plus BCG had already been approved in a related study of bladder cancer patients from the same study population. 

FDA Focuses On Papillary, CIS Similarities

ImmunityBio said the FDA specifically pointed to scientific evidence suggesting that papillary bladder cancer and carcinoma in situ (CIS) may be more closely related than traditionally viewed. According to the company, the filing included research, which said that the two forms of bladder cancer share similar biological behavior and disease characteristics. 

ImmunityBio said the FDA will review the similarities in deciding whether Ankitva's currently approved use could be expanded to patients with papillary-only disease. 

The filing came one day after an FDA workshop discussing bladder cancer trial design and treatment decisions in real-world clinical practice. ImmunityBio said panelists at the meeting said that CIS and papillary disease “arise from the same cancer-inducing clone” and are biologically the same disease. 

“The feedback from the thought leaders at the FDA workshop meeting relating to the real-world clinical treatment of patients with papillary disease alone was significantly important in informing the Agency,” Soon-Shiong said.

IBRX Flags Bladder-Sparing Results

The application is backed by results from ImmunityBio’s Quilt-3.032 study, which tested Anktiva plus BCG in 80 patients with high-risk papillary bladder cancer that no longer responded to standard BCG therapy. The company said that 58.2% of patients remained disease-free after 12 months. ImmunityBio also highlighted bladder preservation results, an important issue since many patients eventually face bladder removal surgery after standard treatment options fail.

According to ImmunityBio, the study showed that more than 80% of patients avoided bladder removal surgery through three years of follow-up. The company also said nearly 95% of patients had not seen their disease worsen after one year, while 82% remained progression-free after three years. 

IBRX Moves Past FDA Setbacks

The FDA acceptance follows a turbulent period for ImmunityBio, which included both regulatory setbacks and promotional scrutiny of Anktiva. Last year, the FDA refused to review essentially the same Anktiva expansion application despite ImmunityBio saying senior agency officials had previously encouraged the filing based on data from its Quilt-3.032 bladder cancer study.

More recently, the company received an FDA warning letter regarding promotional claims for Anktiva. Regulators cited statements from a television advertisement draft and Soon-Shiong’s earlier appearance on The Sean Spicer Show as examples of claims suggesting uses beyond the therapy’s approved indication. However, the founder later pushed back publicly, saying a television advertisement cited by regulators “never aired at all” and arguing that the dispute stemmed from broader tensions between scientific discussion and FDA promotional rules. 

ImmunityBio later removed the podcast from its website and submitted a formal response outlining compliance measures, including better procedures for promotional review and regulatory oversight. 

IBRX Pushes Full Speed Into Global Expansion

Even as ImmunityBio battled growing FDA scrutiny, the company continued aggressively expanding Anktiva globally through new supply deals, overseas launches and international partnerships.

The company recently signed an exclusive U.S. agreement with Japan BCG Laboratory for the Tokyo-172 strain of BCG, giving ImmunityBio a second potential supply source amid chronic U.S. shortages of bladder cancer treatments. 

Anktiva was originally approved by the FDA in 2024 for patients whose bladder cancer no longer responds to standard BCG treatment and who have CIS. Since then, the therapy has expanded internationally across the UK, EU and Macau, while the European Commission later broadened authorization across 33 countries. 

The National Comprehensive Cancer Network (NCCN) also added Anktiva plus BCG as an “other recommended” option for certain patients with papillary bladder cancer after standard BCG treatment fails. Earlier this year, ImmunityBio launched Anktiva in Saudi Arabia for certain patients with bladder and lung cancer as part of a broader Middle East expansion strategy. Soon-Shiong has also signaled wider international plans, including meetings in Greece with Prime Minister Kyriakos Mitsotakis and separate expansion talks in Turkey.

How Do Retail Traders Feel About IBRX?

On Stocktwits, retail sentiment for IBRX was ‘extremely bullish’ amid ‘high’ message volume.

One user said, “Proud of all of us long-term diamond hand bulls that have been here since 2025 or before. As I’ve said 1000 times, my 41,000 shares will never be sold. I will hold them for many MANY years.”

Another user said, “Obviously, I’m happy with the PDUFA date. On top of that, something dawned on me: the 7-month PDUFA timeline is a bit unusual, but maybe not so strange after all. I think they’re building in the time needed to also approve the Tokyo strain BCG, so both can be approved together.”

IBRX stock has surged 292% so far this year. 

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