ImmunityBio Inc. (NASDAQ:IBRX) shares are up Tuesday following the announcement that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Bladder Cancer.

The agency included Anktiva in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only disease.

ImmunityBio Bladder Cancer Drug Included In Treatment Guideline

The update expands previous NCCN clinical guideline recommendations, which included patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary disease.

Both recommendations are Category 2A.

The immunotherapy regimen is designed to activate natural killer (NK) cells and T cells and has demonstrated durable responses in clinical studies.

The NCCN guideline reference to Anktiva for patients with BCG-unresponsive NMIBC with papillary-only disease reflects a use that is not included in the current U.S. Food and Drug Administration (FDA) approved indication for Anktiva.

Richard Adcock, President and CEO of ImmunityBio, emphasized that this update validates the evolving clinical guidance for patients and underscores the importance of immune-based therapies.

In addition, the company continues to engage with payers and healthcare institutions to support education and appropriate access consistent with approved labeling.

Anktiva received FDA approval in April 2024 for use in combination with BCG and is currently covered by insurance plans representing over 100 million insured patients in the United States.

FDA Resubmission

Last week, the FDA acknowledged receipt of ImmunityBio's sBLA for Anktiva in treating BCG-unresponsive NMIBC.

The resubmission follows ongoing discussions with the FDA that began in January 2026, where the agency requested additional data to support its review, leading to the submission of updated efficacy data in March.

In May 2025, ImmunityBio received a Refusal to File (RTF) letter from the FDA for the supplemental biologics license application (sBLA) for the use of Anktiva plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease.

Establishes Safe, Reproducible, Scalable Manufacturing Pathway

On Friday, ImmunityBio completed its NK2022 (Cancer and Healthy Volunteers) and NK2023 (Healthy Volunteers) programs, which evaluated the safety and reproducibility of its autologous memory cytokine-enhanced natural killer (M-ceNK) cell therapy.

Sixty-four subjects participated, with no serious adverse events reported, and the company highlighted its ability to generate up to five billion NK cells from a single apheresis collection.

Additionally, the company is advancing its phase 1 trial (QUILT-3.076), combining M-ceNK cells with ANKTIVA, which has demonstrated promising antitumor activity across multiple cancer types.

Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $12.57. Recent analyst moves include:

  • BTIG: Buy (Target $13.00) (Mar. 12)
  • D. Boral Capital: Buy (Maintains Target to $23.00) (Mar. 9)
  • Piper Sandler: Overweight (Raises Target to $12.00) (Mar. 4)

IBRX Price Action: ImmunityBio shares were up 2.01% at $8.37 at the time of publication on Tuesday, according to Benzinga Pro data.

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