IBRX Stock Finds Retail Cheer After Company’s Immunotherapy For Bladder Cancer Gets Saudi FDA Approval

The approval in Saudi Arabia follows authorizations in the U.S. and the U.K., as well as a conditional approval in the European Union.

• ImmunityBio plans to establish a regional office in Saudi Arabia to support its expansion across the Middle East and North Africa.
• The company will also partner with regional pharmaceutical firm BioPharma Cigalah.
• Enrolment for the QUILT-2.005 study evaluating ANKTIVA with BCG in earlier-stage bladder cancer is expected to be completed by the second quarter.

ImmunityBio, Inc. (IBRX) drew retail attention on Wednesday as the stock jumped 8% after the Saudi Food and Drug Authority approved ANKTIVA in combination with the BCG (Bacillus Calmette-Guérin) vaccine to treat adults with BCG-unresponsive non-muscle invasive bladder cancer.

The approval marks a major regulatory milestone, adding to existing authorizations in the United States and the United Kingdom, as well as conditional approval in the European Union.

“We are pleased to bring ANKTIVA to Saudi patients with NMIBC, who otherwise have no viable options but life-altering surgery,” said Rich Adcock, Chief Executive Officer, ImmunityBio.

ImmunityBio’s Expansion Plans

ImmunityBio plans to establish a regional office in Saudi Arabia to support its expansion across the Middle East and North Africa. The company will also partner with regional pharmaceutical firm BioPharma Cigalah. Management cited the rising incidence of bladder and other cancers in the region as a key driver behind the strategy.

ANKTIVA is an Interleukin-15 (IL-15) receptor agonist. IL-15 is an immune system protein that helps develop and activate key cells that work to destroy cancer cells.

ANKTIVA Developments

Beyond bladder cancer, ANKTIVA is also drawing attention for its broader oncology potential. Recent clinical data from the QUILT-2.023 and QUILT-3.055 trials in non-small cell lung cancer (NSCLC) showed improved immune recovery and extended survival when ANKTIVA was combined with checkpoint inhibitors.

Responding patients achieved a median survival of up to 21.1 months, significantly outperforming traditional chemotherapy outcomes.

Meanwhile, enrolment for the company’s QUILT-2.005 study evaluating ANKTIVA with BCG in earlier-stage bladder cancer is expected to be completed by the second quarter (Q2) of 2026 and a potential biologics license application (BLA) by the end of the year.

How Did Stocktwits Users React?

Retail sentiment on Stocktwits around ImmunityBio remained in the ‘extremely bullish’ zone, amid ‘extremely high’ message volumes.

One user speculated that the approval could double the product revenue for the company.

One user sees the stock climb to $5 in the short term and $15-25 in the medium term.

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Over the past year, IBRX shares have risen around 21%.

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