ImmunityBio Inc. ( IBRX ) shares are down during Thursday’s premarket session. Year to date, the stock has jumped over 300%.

The company announced that the Independent Data Monitoring Committee (IDMC) confirmed the statistical power of its pivotal randomized trial for Anktiva.

Pivotal Trial Deemed Adequately Powered

The IDMC’s review indicated that no additional enrollment is needed beyond the current 366 participants, confirming that the study is adequately powered to detect a clinically meaningful difference in complete response (CR) rates.

The trial, known as QUILT-2.005, is evaluating Anktiva in combination with Bacillus Calmette-Guérin (BCG) for patients with non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary disease.

Interim Analysis Supports Study Design

In February, ImmunityBio ( IBRX ) announced enrollment was complete in the pivotal randomized trial. By March 2026, 50% of enrolled patients were evaluable (N=183) for the primary efficacy endpoint.

Upon reaching this pre-specified 50% evaluable threshold, a planned interim analysis by an IDMC was initiated per protocol to verify that the 366 patients enrolled to date provide sufficient statistical power to detect the pre-specified clinically meaningful difference in CR rate between the two arms.

In the context of this trial, ImmunityBio ( IBRX ) has highlighted the promising results from earlier phases, where patients showed a prolonged duration of complete remission.

Regulatory Path And Pipeline Progress

The company plans to submit a supplemental Biologics License Application based on the final data analysis in 2026.

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

On Tuesday, the U.S. Food and Drug Administration (FDA) determined that a direct-to-consumer TV ad and podcast promoting Anktiva were false or misleading and misbranded the drug under federal law. 

The FDA said the materials made unsupported claims that Anktiva could cure or prevent cancer and suggested effectiveness beyond its approved use, including treatment for multiple cancers and use as a standalone therapy. 

Last week, the National Comprehensive Cancer Network updated its Clinical Practice Guidelines in Oncology for Bladder Cancer and included Anktiva plus BCG for BCG-unresponsive NMIBC with papillary-only disease.

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

D. Boral Capital: Buy (Maintains Target to $23.00) (Mar. 23)

BTIG: Buy (Target $13.00) (Mar. 12)

Top ETF Exposure

Virtus LifeSci Biotech Products ETF : 4.03% Weight

IBRX Stock Price Activity: ImmunityBio ( IBRX ) shares were down 2.44% at $7.87 during premarket trading on Thursday, according to Benzinga Pro data.

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