ImmunityBio's Anktiva sales rise 53% to $48.7m after wider US approval
The company reports a larger eligible US patient group, a 35th approval worldwide and a planned filing in earlier-stage disease as third-quarter product revenue grows.
ImmunityBio reported net product revenue of $48.7 million for Anktiva in the third quarter of 2026, up 53% on the same quarter a year earlier. The figure comes from the company's own announcement on 9 November, and the drug's revenue trajectory is now tied to a broader US label.
The FDA cleared a supplemental application on 14 October that extends Anktiva, given alongside BCG, to adults with BCG-unresponsive non-muscle invasive bladder cancer whose tumours are papillary-only. The company did not set out in the material available how many patients this adds or how it expects the change to affect sales.
Outside the US, ImmunityBio said Israel has approved the product, which it describes as the 35th approval globally. It also said the first patients in Europe have been treated. The information available does not say through which regulatory route, or in which countries, that treatment is taking place.
The company is also looking at earlier disease. It said the QUILT-2.005 cohort of BCG-naïve patients reached its primary endpoint and that it plans to file a supplemental application for that group in the fourth quarter of 2026. No detailed data were provided, and the filing date is the company's intention, not a regulatory commitment.
Why it matters
- The revenue growth and label change are reported together, but the available information does not show how much of the quarter's sales the expanded indication drove.
- A BCG-naïve filing, if made in Q4 2026, would put a second indication expansion before the FDA, though efficacy data have yet to be disclosed.
- Details of the European treatments are limited, so their commercial significance cannot yet be judged.
Company's press release (SEC filing): ImmunityBio, Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.