New York, January 20, 2026, 20:22 ET — The market has closed.
- After a volatile session, shares jumped 17.7% to close at $6.48 on Tuesday.
- ImmunityBio revealed the FDA is requesting additional data that might back a resubmission for ANKTIVA in papillary bladder cancer.
- Traders are now focused on the promised submission within 30 days and whether the FDA will agree to review it.
Shares of ImmunityBio, listed on Nasdaq, surged Tuesday following news that U.S. regulators outlined a potential path for the company to pursue an expanded bladder cancer indication for its drug ANKTIVA. The stock closed up 17.7% at $6.48, after trading between $4.94 and $7.97 on heavy volume.
Why it matters now: ANKTIVA stands as ImmunityBio’s flagship commercial product, with the company pushing to expand its label in a tough-to-treat segment of bladder cancer. A more defined path back to the FDA could reset timelines for how fast that label extension progresses—or grinds to a halt.
ImmunityBio reported it recently completed a Type B end-of-phase meeting with the Food and Drug Administration, a key discussion that can influence the agency’s filing requirements. The company is working on a supplemental biologics license application, or sBLA, aiming to expand an existing approval. It plans to submit the requested data within 30 days.
Chief Executive Richard Adcock confirmed the company has “completed the assembly and analysis” of the extra data and plans to submit it for FDA review within 30 days. The company noted the FDA’s request doesn’t call for launching a new clinical trial. CancerNetwork
The focus is on non-muscle invasive bladder cancer with papillary tumors that have stopped responding to BCG (Bacillus Calmette-Guérin), a traditional bladder therapy. ImmunityBio highlighted data shared with the FDA showing about 96% disease-specific survival at three years. They also reported cystectomy avoidance rates of 92% at one year and 82% at three years.
Last year, the company hit a snag when the FDA issued a refusal-to-file letter, declining to accept their application for review. Tuesday’s update indicates ImmunityBio is working to address the FDA’s concerns without launching a new trial.
The FDA’s decision will be closely monitored beyond just ImmunityBio. Johnson & Johnson has signaled it plans to wait for a randomized readout from its Sunrise-5 trial of TAR-200 before submitting in the same BCG-unresponsive papillary bladder cancer setting, according to OncologyPipeline.
Analysts jumped in as well. Piper Sandler upped its price target for ImmunityBio to $7 from $5, maintaining an Overweight rating, TheFly reported.
In a separate development, a Form 144 filing revealed a shareholder intends to sell 25,000 shares acquired via option exercise. These filings signal possible sales but don’t mandate them.
The risk is clear: the FDA could request additional analyses, require new studies, or reject a resubmission. Any of those moves would delay the process, leaving surgery or bladder-sparing alternatives as the primary options for many patients.
U.S. markets remain closed, leaving the spotlight on what happens before Wednesday’s open after a choppy session. All eyes are on the company’s pledge to file within 30 days — roughly by Feb. 19 — and if the FDA will greenlight the resubmitted sBLA for review.
