New York, Feb 19, 2026, 05:05 ET — Premarket
- ImmunityBio slipped 0.5% before the bell, following a sharp 41.9% jump in the previous session.
- Europe granted conditional marketing authorization for Anktiva combined with BCG in a type of bladder cancer, prompting the move.
- Attention turns to specifics on the EU launch, fresh data from upcoming medical meetings, and the next earnings release.
ImmunityBio slipped roughly 0.5% to $8.50 before the bell, after soaring 41.9% Wednesday and finishing at $8.54. The move came after the biotech announced the European Commission had greenlit its bladder cancer drug Anktiva for a major regional launch. (Investing)
Anktiva (nogapendekin alfa inbakicept) has secured a conditional marketing nod in the European Union, paired with Bacillus Calmette-Guérin, or BCG—a bladder cancer immunotherapy that’s been around for decades—for adults whose non-muscle invasive bladder cancer isn’t responding to BCG. The disease hasn’t reached the bladder muscle. ImmunityBio says this clears the way for commercial rollout in all 27 EU countries, plus Iceland, Norway, and Liechtenstein, putting the drug in 33 markets. (ImmunityBio)
Why the qualifier is key: “Conditional” approvals in the EU push drugs out faster in cases of unmet need—but the catch is, companies face extra requirements. These approvals run for just a year at first, then must be renewed yearly as firms supply follow-up data that regulators demand after the green light. (European Medicines Agency (EMA))
ImmunityBio is pushing harder on the access angle this week. On Tuesday, the company said Saudi regulators had urged it to submit a package for its recombinant BCG within the next few weeks, as it hunts for new supply routes during ongoing shortages. It also highlighted ongoing talks about using Anktiva with checkpoint inhibitors — those tumor-spotting immune therapies — in more cancer types. (ImmunityBio)
Anktiva grabbed U.S. FDA clearance back in April 2024 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, the flat high-risk type found in the bladder lining. That nod followed an earlier FDA rejection over manufacturing problems, as Reuters noted. (Reuters)
The field’s packed and in flux. Merck landed FDA clearance for Keytruda back in 2020—specifically targeting certain high-risk non-muscle invasive bladder cancer patients who can’t or won’t have their bladders removed, and who don’t respond to BCG. Pfizer, not standing still, has advanced its own bladder cancer effort, touting late-stage trial results it claims hit the primary endpoint. (U.S. Food and Drug Administration)
Turnover surged on Wednesday, with trading volume swelling to about 78 million shares, Nasdaq.com data showed. Momentum traders jumped in following the EU’s move, fueling the rally. (Nasdaq)
But the risk is clear enough: if post-authorization obligations aren’t met, the EU’s pathway can snap shut quickly. The annual renewal keeps a regulatory timer ticking in the background. Even once authorization lands, actual access and uptake? Those depend on each country’s reimbursement call and when the rollout happens. (European Medicines Agency (EMA))
Looking ahead, traders are keyed in on any hints around launch timing in Europe and whatever ImmunityBio has to say about demand trends. The ASCO Genitourinary Cancers Symposium kicks off in San Francisco Feb. 26–28—bladder cancer updates there could move the needle in a hurry. (Asco)
A nearer-term catalyst could be on deck for the stock. ImmunityBio is slated to deliver results in early March, with market calendars flagging March 2 as the date to watch for the next earnings release. (Zacks)
