New York, Feb 20, 2026, 07:23 a.m. EST — Premarket
- ImmunityBio shares are set to open near a 52-week high after the EU cleared ANKTIVA with BCG for a form of bladder cancer
- The company is leaning on Accord Healthcare and a new Dublin unit for a European rollout, while it works on a U.S. label expansion
- Traders are watching for fresh details at ASCO GU later this month and for any FDA feedback on the new submission
ImmunityBio shares hovered near a 52-week high in premarket trade on Friday after a filing showed the European Commission had granted conditional marketing authorization for its bladder cancer immunotherapy ANKTIVA in combination with BCG. The Nasdaq-listed stock was down about 0.1% at $8.60, after closing Thursday at $8.61; it jumped 41.9% on Wednesday with roughly 80 million shares changing hands. (SEC)
The European green light matters because ImmunityBio is trying to turn ANKTIVA from a U.S. launch into a broader commercial franchise. Investors have shifted from “does it get approved” to “does it sell,” and Europe brings a new set of pricing talks and rollout hurdles.
This is also the kind of regulatory win that pulls a small biotech back onto traders’ screens, even if the stock has already moved. The next question is execution.
On Thursday, ImmunityBio laid out its early Europe playbook, announcing a distribution partnership with Accord Healthcare and a Dublin-based subsidiary to support the launch. Chief executive Richard Adcock called the deal “a significant step in our European growth strategy,” while Accord CEO Paul Tredwell pointed to “expanding access” for patients; ImmunityBio also said it had submitted a response to the U.S. FDA’s request for more data tied to an expansion bid in papillary-only bladder disease. (Business Wire)
The EU decision came via a “conditional” route — an approval that allows earlier sales while requiring more safety and efficacy data after launch and annual renewals. ImmunityBio said the authorization covers all 27 EU member states plus Iceland, Liechtenstein and Norway, taking ANKTIVA’s footprint to 33 countries across the EU, U.S., UK and Saudi Arabia; it said a single-arm study in 100 adults showed a 71% complete response rate and a median response duration of 26.6 months in non-muscle invasive bladder cancer with carcinoma in situ. Founder Patrick Soon‑Shiong said the authorization “marks a defining moment for patients,” while Adcock said the company was focused on “timely pricing, reimbursement, and patient access” across Europe. (ImmunityBio)
Analyst chatter followed the rally. Data compiled by Benzinga showed D. Boral Capital maintained a buy rating on Feb. 19 with a $24 price target. (Benzinga)
Non-muscle invasive bladder cancer is an early-stage disease that has not yet grown into the bladder muscle. Patients are often treated with BCG — Bacillus Calmette-Guérin — an immune-based therapy delivered into the bladder, and those who stop responding can face bladder removal surgery.
But conditional approvals come with strings, and Europe’s reimbursement process can be slow and country-by-country. Commercial uptake can also hinge on how quickly clinics adopt a new regimen and how smoothly supply and distribution work in the first wave.
For Friday’s regular session, traders will be watching whether the stock holds onto this week’s gains and whether the company adds any clarity on launch timing and pricing work in Europe. U.S. investors also tend to key off any hint of how the FDA views the new submission for the papillary-only expansion.
The next near-term date on the calendar is the ASCO Genitourinary Cancers Symposium (ASCO GU) in San Francisco on Feb. 26–28, where the company is scheduled to appear. (Immunitybio)
