ImmunityBio Inc. (IBRX) announced Tuesday that it's ready to resubmit its application to expand the use of Anktiva, its bladder cancer treatment, after receiving helpful guidance from the FDA. The company plans to submit the additional information within 30 days following a Type B end-of-phase meeting about its supplemental biologics license application for treating papillary non-muscle invasive bladder cancer.

Investors clearly liked what they heard. The stock traded with session volume of 178.91 million shares versus the typical 15.9 million average.

Here's the setup: The FDA held discussions with ImmunityBio about using Anktiva (nogapendekin alfa inbakicept) combined with Bacillus Calmette-Guérin for patients with BCG-unresponsive papillary NMIBC. The agency's recommendations are designed to support a potential resubmission of the application initially filed in 2025, and crucially, they don't require starting a new clinical trial from scratch.

During the meeting, ImmunityBio presented updated clinical results from its papillary disease program, including more than five years of follow-up data. The numbers are genuinely impressive.

The Clinical Picture

The company reported disease-specific survival of approximately 96% at 36 months, with median survival not yet reached. That means patients are living long enough that researchers still can't calculate when half of them might pass away. Meanwhile, cystectomy avoidance rates hit 92% at one year and 82% at three years. In plain English, that means the vast majority of patients kept their bladders instead of needing surgical removal. The safety profile remained consistent with Anktiva's currently approved indication in carcinoma in situ.

The proposed papillary indication builds on results from the QUILT-3.032 Phase 2/3 trial, which enrolled 80 patients with high-grade, papillary-only BCG-unresponsive NMIBC.

Published in The Journal of Urology in 2025, the study met its primary endpoint with a 12-month disease-free survival rate of 58.2%. Progression-free survival reached 94.9% at 12 months and 83.1% at 36 months.

ImmunityBio emphasized that more than 80% of patients avoided cystectomy through three years of follow-up, positioning Anktiva as a potential bladder-sparing alternative for this high-risk population. That's a big deal for patients who otherwise might face bladder removal surgery.

Anktiva already has approval in the U.S. and several international markets for BCG-unresponsive NMIBC with carcinoma in situ. This application would expand its use to papillary cases.

Pipeline Progress and Revenue Surge

On Friday, the company reported that enrollment exceeded internal expectations in its randomized registrational trial in BCG-naïve non-muscle-invasive bladder cancer, called QUILT-2.005. Enrollment is now over 85% complete, with full enrollment of the planned study population anticipated by the second quarter of 2026.

Meanwhile, the revenue story is equally compelling. ImmunityBio announced preliminary net product revenue for Anktiva reached approximately $113 million for fiscal 2025, reflecting a remarkable 700% increase year-over-year.

For the fourth quarter of 2025, the company reported revenue of about $38.3 million, surpassing the previous quarter's $31.8 million. That marks a 20% quarter-over-quarter increase and a 431% year-over-year increase.

What Analysts Are Saying

Piper Sandler maintains ImmunityBio with an Overweight rating and raised the price target from $5 to $7.

D. Boral Capital maintains ImmunityBio with a Buy rating and a price target of $24.

IBRX Price Action: ImmunityBio shares were up 20.44% at $6.64 at the time of publication on Tuesday. The stock is trading at a new 52-week high.