ImmunityBio Says Phase 2 Bladder Cancer Trial Has ‘Statistical Power’ – Anktiva-BCG Advances Toward Filing

• The committee concluded that no additional patient enrollment was required.
• ImmunityBio said the results support a supplemental BLA submission planned for later this year.
• The update came after Patrick Soon-Shiong said about half of patients in the study have reached a stage where the treatment’s effectiveness can be evaluated.

ImmunityBio (IBRX) said on Thursday that its QUILT-2.005 clinical trial evaluating Anktiva plus Bacillus Calmette-Guérin (BCG) in patients with BCG-naïve non-muscle invasive bladder cancer remains on track for final analysis and a supplemental regulatory filing in 2026.

IBRX stock was down around 2% at the time of writing.

IDMC Sees Sufficient Statistical Power In Trial

The Independent Data Monitoring Committee (IDMC) reviewed interim data from 183 evaluable patients, about half of the 366 participants enrolled in the study. The committee confirmed the trial has sufficient statistical power to detect a meaningful difference in complete response rates between the Anktiva plus BCG combination and BCG alone.

Based on the review, the committee concluded that no additional patient enrollment is required. ImmunityBio said the results support a supplemental Biologics License Application (BLA) submission planned for later this year.

This update followed comments from founder and executive chairman Patrick Soon-Shiong, who said on X that about half of the patients in the QUILT-2.005 bladder cancer study—evaluating the therapy in individuals newly starting standard BCG treatment—have now reached a key milestone where its effectiveness can be assessed.

FDA Warning On Misleading Anktiva Promotion

ImmunityBio stock crashed on Tuesday after the U.S. Food and Drug Administration (FDA) issued a warning letter over the promotion of Anktiva. The regulator said the company’s marketing created a misleading impression that the treatment could cure or prevent multiple cancers. 

The FDA highlighted a TV ad and a podcast featuring CEO Richard Adcock and Executive Chairman Patrick Soon-Shiong, calling the claims exaggerated. According to the agency, the drug has not been proven to keep all bladder cancer patients cancer-free long term.

The FDA has asked the company to respond within 15 days and correct the issues or face possible legal action.

How Did Retail Traders React?

Retail sentiment on Stocktwits remained ‘bullish’ over the past 24 hours.

One user speculated potential revenue from the company’s lung cancer treatment.

Another user said the downward price manipulation will end up subsidizing a potential buyback.

Year-to-date, the stock has gained nearly 300%.

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