New York, Jan 22, 2026, 08:54 ET — Premarket
- Shares climbed roughly 6.5% in early trading
- Company reports FDA requested additional data to back a possible resubmission aimed at expanding ANKTIVA’s approved uses
- Traders are eyeing the FDA’s next move following the company’s intent to submit within 30 days
ImmunityBio shares climbed in premarket trading Thursday following the company’s announcement that U.S. regulators have specified the requirements for a new filing to expand the use of its bladder cancer treatment.
This update is crucial since it sharpens a key investor question: can ImmunityBio chase a label expansion without launching fresh trials, which would mean added time and expense?
Attention remains on ANKTIVA, the company’s flagship commercial product, as small-cap biotech investors look for firmer regulatory timelines before the market opens.
ImmunityBio climbed roughly 6.5% to $6.92 in pre-market trading, up from its previous close around $6.50.
ImmunityBio recently held a Type B End-of-Phase meeting with the FDA regarding its supplemental biologics license application (sBLA) to broaden ANKTIVA’s indication for BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. The FDA advised the company to submit more data for review. ImmunityBio said it will provide this additional information within 30 days and does not plan to initiate a new clinical trial.
“We appreciate the FDA’s collaboration,” CEO Richard Adcock said in a statement, noting the company has “completed the assembly and analysis” of the requested data. ImmunityBio also highlighted longer-term trial follow-up showing about 96% bladder cancer-specific survival at three years, along with over 80% bladder preservation at three years in patients with papillary disease. ImmunityBio
ANKTIVA has been approved in the U.S. for a more limited bladder cancer indication: BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS), with or without papillary tumors, used alongside BCG. BCG itself is an older immune-based treatment administered directly into the bladder.
Other FDA-approved treatments in the high-risk, BCG-unresponsive NMIBC category include Merck’s Keytruda, approved for select patients with CIS, and Ferring’s Adstiladrin gene therapy, which covers CIS with or without papillary tumors.
Insider selling poses another risk for momentum traders. Director Barry J. Simon disclosed stock sales from Jan. 20, executed under a Rule 10b5-1 plan, according to a Form 4 filing.
The main unknown remains the FDA. It can demand additional analyses, extra data, or a revised study design before considering any resubmission, which could swiftly alter the timeline.
Traders are zeroing in on whether ImmunityBio meets the deadline for submitting the requested package, and on the FDA’s next move — particularly if the agency considers any resubmission complete and ready for review.
