ImmunityBio Inc. (NASDAQ:IBRX) on Tuesday said it plans to submit additional information to the U.S. Food and Drug Administration (FDA) within 30 days following a Type B end-of-phase meeting related to its supplemental biologics license application for Anktiva in papillary non-muscle invasive bladder cancer (NMIBC).

The stock is trading higher with a session volume of 178.91 million versus the average volume of 15.9 million, as per data from Benzinga Pro.

The company said the FDA provided feedback during discussions on Anktiva (nogapendekin alfa inbakicept), in combination with Bacillus Calmette-Guérin for patients with BCG-unresponsive papillary NMIBC.

ImmunityBio noted the agency's recommendations are intended to support a potential resubmission of the sBLA filed initially in 2025 and do not require the initiation of a new clinical trial.

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

Data

The company highlighted disease-specific survival of approximately 96% at 36 months, with median survival not yet reached, along with cystectomy avoidance rates of 92% at one year and 82% at three years. The safety profile was described as consistent with Anktiva's currently approved indication in carcinoma in situ.

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

As published in The Journal of Urology in 2025, the study met its primary endpoint, achieving a 12-month disease-free survival rate of 58.2%. Progression-free survival was 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.

Anktiva is already approved in the U.S. and several international markets for BCG-unresponsive NMIBC with carcinoma in situ.

On Friday, the company said enrollment exceeded internal expectations in its randomized registrational trial in BCG-naïve non-muscle-invasive bladder cancer (NMIBC), QUILT-2.005.

Enrollment is now over 85% complete, with full enrollment of the planned study population anticipated by the second quarter of 2026.

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, marking a 20% quarter-over-quarter increase and a 431% year-over-year increase.

Analyst Take

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

D. Boral Capital maintains ImmunityBio with a Buy and maintains a price forecast 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, according to Benzinga Pro data.

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