New York, Feb 20, 2026, 07:23 a.m. EST — Premarket
- ImmunityBio shares look primed to start trading close to a 52-week high following the EU’s green light for ANKTIVA combined with BCG in treating a type of bladder cancer.
- The company is turning to Accord Healthcare and a fresh Dublin operation for its European push, even as it pursues a label expansion in the U.S.
- Traders now await more information at ASCO GU later this month, as well as any FDA feedback on the latest submission.
ImmunityBio shares sat just below their 52-week high in premarket trading Friday, following news from a filing that the European Commission granted conditional marketing authorization for its ANKTIVA bladder cancer immunotherapy, used alongside BCG. The stock, listed on the Nasdaq, edged down 0.1% to $8.60 after Thursday’s close at $8.61. On Wednesday, it surged 41.9% with about 80 million shares traded.
Getting the OK in Europe is significant for ImmunityBio, which wants to push ANKTIVA beyond its initial U.S. debut and build out a wider commercial footprint. Now that approval is in, investor focus has flipped: it’s less about whether ANKTIVA gets the nod and more about whether it gains traction in the market. The European stage, though, means new pricing negotiations and fresh obstacles for the rollout.
Regulatory wins like this tend to throw a spotlight back on a small biotech, sometimes after the stock has already made a run. What comes next? Execution.
ImmunityBio on Thursday mapped out its initial strategy for Europe, rolling out a distribution deal with Accord Healthcare and setting up a Dublin subsidiary to back the launch. CEO Richard Adcock called the move “a significant step in our European growth strategy.” Accord’s chief, Paul Tredwell, cited “expanding access” for patients. The company also noted it had submitted a reply to the U.S. FDA’s request for additional data related to its papillary-only bladder disease expansion effort. Business Wire
The EU gave the nod through a “conditional” approval, opening the door to earlier sales but tying continued access to ongoing safety and efficacy data and yearly renewals. ImmunityBio said the decision extends to all 27 EU countries, plus Iceland, Liechtenstein, and Norway. That pushes ANKTIVA’s reach to 33 markets, including the EU, U.S., UK, and Saudi Arabia. The company pointed to results from a single-arm trial in 100 adults, showing a 71% complete response rate and a median response of 26.6 months in non-muscle invasive bladder cancer with carcinoma in situ. Founder Patrick Soon‑Shiong called it “a defining moment for patients.” Adcock highlighted priorities around “timely pricing, reimbursement, and patient access” throughout Europe. ImmunityBio
Analysts weighed in after the surge. Benzinga’s data showed D. Boral Capital stuck with its buy rating on Feb. 19, holding to a $24 price target.
Non-muscle invasive bladder cancer hasn’t yet penetrated the bladder’s muscle layer. Standard treatment typically involves BCG, or Bacillus Calmette-Guérin, an immunotherapy given directly into the bladder. But for patients whose cancer stops responding, bladder removal often becomes the next option.
Still, conditional approvals are rarely straightforward—Europe’s drawn-out, country-specific reimbursement process often complicates things. On top of that, commercial traction depends a lot on clinics’ willingness to switch regimens and whether supply and distribution hold up early on.
Friday’s regular session brings two things into focus: will the stock hang on to this week’s run-up, and does the company offer any hints on European launch timing or pricing? U.S. investors are also zeroed in on any scraps about how the FDA’s viewing the fresh papillary-only submission.
Coming up, the company has a spot at the ASCO Genitourinary Cancers Symposium (ASCO GU) in San Francisco, set for Feb. 26–28.
