Wednesday's trading session is proving to be a thrilling one for ImmunityBio (IBRX 5.44%) shareholders. As of 1:50 p.m. ET today the biopharma stock is up an incredible 33.1%. The reason? Unsurprisingly, an approval of its breadwinning drug in another huge market.
Approved... again
ImmunityBio's oncology drug Anktiva had already been approved as a treatment for certain forms of bladder cancer as early as 2024, for the record, when the United States' FDA gave the immunotherapy the green light. The United Kingdom followed suit in the middle of 2025, with the Kingdom of Saudi Arabia coming around in January of this year.
On Wednesday, however, the company announced that the European Union's regulatory commission has approved the combination of its Anktiva and vaccine Bacillus Calmette-Guérin (BCG) as treatment for non-muscle invasive bladder cancer in the 30 countries it represents.
NASDAQ: IBRX
Key Data Points
The market's bullish response is understandable too, given what we know about demand for the immunotherapy thus far. Although the drug's only been sold within the U.S. for less than two years and only won the UK's approval a few months ago, the company expects to report $113 million worth of Anktiva revenue for the fiscal year ending in December, with quarter-over-quarter growth of 20% in the final quarter of 2025 alone. That's a lot for a relatively new drug in one market, and a nearly brand-new drug in another. It's still years away from reaching its peak sales potential.
Image source: Getty Images.
Bladder cancer isn't Anktiva's only target either. ImmunityBio is also testing the drug as a treatment for solid tumors, Lynch Syndrome, HIV, ovarian cancer, and Non-Hodgkin Lymphoma.
Just respect the risk
There's potential upside here to be sure. ImmunityBio is a relatively small company (a market cap of less than $8 billion) with a promising cancer therapy that should be competitive within a worldwide oncology market Global Market Insights expects to grow from less than $350 billion last year to more than $860 billion in 2034, with the cancer immunotherapy piece of this market alone expected to be worth $277 billion by 2032. That's roughly twice its current size. Even capturing just some of this growth could prove to be a windfall for ImmunityBio.
Still, interested investors must respect the fact that such extreme bullish volatility can invite near-term profit-taking. It wouldn't be wrong for anyone who can stomach the risk to let today's dust settle before jumping in.
