New York, January 21, 2026, 08:47 EST — Premarket
ImmunityBio’s stock dropped 5.9% to $6.10 in premarket trading Wednesday. The move followed the company’s announcement of a meeting with the U.S. Food and Drug Administration to discuss a possible resubmission of its bladder-cancer treatment, ANKTIVA.
This move is significant because the FDA rejected ImmunityBio’s application last year to expand ANKTIVA for BCG-unresponsive papillary non-muscle invasive bladder cancer. The company is now making another attempt, claiming a clearer regulatory pathway. That strategy stands in contrast to Johnson & Johnson’s, which has focused on gathering randomized data before filing in the same indication, OncologyPipeline reported.
ImmunityBio stressed the urgency, noting that patients relapsing after BCG—a vaccine-based treatment injected into the bladder—quickly face dwindling bladder-sparing options. The company highlights that no targeted therapies have gained approval for BCG-unresponsive papillary disease, leaving radical cystectomy, or bladder removal, as the usual fallback.
ImmunityBio said the FDA has asked for more information to consider a possible resubmission of its supplemental Biologics License Application, or sBLA, which seeks to expand the label of an approved biologic. “We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days,” President and CEO Richard Adcock stated. ImmunityBio
The company reminded investors of long-term data backing the papillary indication, spotlighting the QUILT-3.032 Phase 2/3 trial involving 80 patients. It reported a 12-month disease-free survival rate of 58.2%, adding that over 80% of patients avoided cystectomy after three years of follow-up.
In April 2024, ANKTIVA gained U.S. approval for use alongside BCG to treat high-risk non-muscle invasive bladder cancer patients with carcinoma in situ, whether or not papillary tumors are present. This came after a 2023 FDA rejection linked to manufacturing problems, Reuters reported.
ImmunityBio surged 17.39% to $6.48 on Tuesday, hitting an intraday peak of $7.98. More than 209 million shares changed hands.
Some analysts wasted no time. Piper Sandler raised its price target to $7 and maintained an overweight rating. Meanwhile, HC Wainwright’s A. Maldonado forecasted that ImmunityBio will post earnings of $0.68 per share in fiscal 2030, according to a MarketBeat summary of recent notes.
The BCG-unresponsive bladder cancer field is crowded, though the regulatory battle still centers on the papillary-only subset. Merck’s Keytruda holds FDA approval for high-risk NMIBC patients with carcinoma in situ—whether or not papillary tumors are present—who can’t or won’t undergo cystectomy, according to the agency. Ferring’s gene therapy, Adstiladrin, carries a similar indication for CIS.
Still, the trade depends heavily on regulators. The FDA might rule a resubmission incomplete, demand additional analyses, or require a controlled trial. Any hold-up can hit a small biotech stock hard, especially after a strong rally.
Investors are closely eyeing the company’s commitment to deliver a data package within 30 days, hoping the FDA will accept the resubmission and kick off the review clock without requiring another trial.
