ImmunityBio's ANKTIVA Gains UK Approval for Bladder Cancer Treatment

ImmunityBio, Inc. (IBRX) has gained UK approval for ANKTIVA in bladder cancer, marking its first approval outside the US. The FDA authorized an Expanded Access Program for ANKTIVA in June 2025, and data at ASCO 2025 showed improved survival in metastatic pancreatic cancer patients when paired with CAR-NK therapy. The company is expanding clinical trials and seeking broader FDA approval for ANKTIVA + BCG in bladder cancer.

ImmunityBio, Inc. (IBRX) has made a significant stride in its global expansion by securing UK approval for its lead therapy, ANKTIVA (nogapendekin alfa inbakicept), in the treatment of bladder cancer. This marks the company's first approval outside the United States, where ANKTIVA was previously approved by the FDA for certain types of bladder cancer [1].

The UK approval for ANKTIVA, when used in combination with Bacillus Calmette-Guérin (BCG), is a significant milestone for ImmunityBio. The approval comes on the heels of the FDA's authorization of an Expanded Access Program for ANKTIVA under the Cancer BioShield platform in June 2025. This program allows patients with solid tumors who have failed standard therapies to access ANKTIVA, making it the first approved therapy to target treatment-induced lymphopenia [1].

At the American Society of Clinical Oncology (ASCO) 2025 meeting, data presented showed that restoring immune health with ANKTIVA, especially when paired with CAR-NK therapy, can significantly improve survival in metastatic pancreatic cancer patients. This suggests that ANKTIVA's potential extends beyond bladder cancer, positioning it as a promising treatment option in other cancer types [1].

ImmunityBio is also expanding its clinical trials. The company is conducting a U.S.-based study testing ANKTIVA with PD-1 inhibitors in non-small cell lung cancer (NSCLC) and plans to expand these trials globally. Additionally, ImmunityBio is seeking broader FDA approval for ANKTIVA + BCG in bladder cancer, addressing regulatory hurdles to further broaden its use [1].

Internationally, ImmunityBio is gaining momentum. In July 2025, the UK approved ANKTIVA with BCG for non-muscle invasive bladder cancer (NMIBC), and the company has also formed a partnership with Saudi Arabia's health system to bring the Cancer BioShield platform to the Middle East [1].

Despite these positive developments, ImmunityBio's stock has faced challenges. Over the past year, the stock tumbled by 53.2%, reflecting clinical trial updates that didn't meet investor expectations, ongoing quarterly losses, and the general volatility of biotech stocks [2]. The company's revenue has been growing, with $31.2 million in revenue over the last twelve months, up from $14.8 million in 2024. However, profitability remains elusive, with an operating margin of –863% and a deeply negative return on invested capital [2].

Analysts remain bullish on ImmunityBio, with a Strong Buy rating and an average price target of $11.40, which is 325% higher than the current stock price [2]. Insiders hold a significant portion of shares, indicating confidence in the company's long-term prospects.

References:
[1] https://uk.finance.yahoo.com/news/immunitybio-inc-ibrx-gains-uk-153419085.html
[2] https://finimize.com/content/ibrx-asset-snapshot