New York, January 20, 2026, 08:14 (EST) — Premarket
- ImmunityBio shares were up about 27% in premarket trading, hovering near $7
- Company said the FDA asked for added information to support a possible resubmission for ANKTIVA in papillary bladder cancer, without new trials
- Investors are watching for the data package in the next 30 days and whether the FDA accepts a resubmission for review
ImmunityBio (IBRX.O) shares rose about 27% to $7 in premarket trading on Tuesday, with about 4.1 million shares changing hands, after the company said it had made progress with the U.S. Food and Drug Administration on a path to revive a label-expansion push for its bladder cancer treatment ANKTIVA. (Public)
The Culver City, California-based company said the FDA recommended it submit additional information that could support a resubmission of a supplemental biologics license application, or sBLA, for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. It said the request did not involve designing a new clinical trial and it plans to provide the material within 30 days. (Business Wire)
In a statement, CEO Richard Adcock said, “We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days.” Founder Patrick Soon‑Shiong added: “Patients with BCG-unresponsive papillary NMIBC currently have no approved treatment options aside from life-altering radical cystectomy.” (Stock Titan)
For investors, the clock matters. An sBLA is the route companies use to broaden the U.S. label of an already approved biologic, and a clean resubmission can restart the FDA’s review process.
BCG (Bacillus Calmette‑Guérin) is a bacteria-based therapy placed into the bladder as a standard treatment for some early-stage bladder cancers. “BCG-unresponsive” means the disease has stopped responding, and the company argues many patients are left weighing bladder removal.
Traders also focused on what the company did not say: there was no new trial requirement attached to the FDA’s request, at least at this stage. In biotech, that often shifts the debate from “years” to “months,” even if nothing is guaranteed.
But the regulatory path is still conditional. The FDA can ask for more analyses, request additional studies later, or decide a resubmission is not complete enough to accept for review.
The move also comes in thin, extended-hours trading, when prices can gap on headlines and swing hard on little volume. That can cut both ways once the cash session opens.
Markets will now look for proof in filings: the promised data package to the FDA within the next 30 days, and any sign the agency is prepared to accept a resubmission and set a formal review timeline.
