IBRX Stock Rises Pre-Market After ANKTIVA Combo Shows Stronger Bladder Cancer Responses In Phase 2 Trial
Synopsis
The company said it plans to submit a biologics license application by the fourth quarter of 2026.
Shares of ImmunityBio (IBRX) rose 3% in pre-market trading on Thursday after the company completed enrollment ahead of schedule in its Phase 2 ANKTIVA trial and reported that an FDA-requested interim analysis showed significantly longer complete responses with no major safety concerns.
The Phase 2 trial studied ANKTIVA plus Bacillus Calmette-Guérin (BCG) in patients with BCG-naïve non-muscle invasive bladder cancer. The study enrolled 366 patients, who were randomized to receive either BCG alone or ANKTIVA in combination with BCG.
An interim analysis requested by the U.S. Food and Drug Administration (FDA) showed that the combination significantly improved the duration of complete response, with no major safety concerns. At nine months, 84% of patients on the combo maintained a complete response, compared with 52% on BCG alone.
The company plans to submit a biologics license application by the fourth quarter of 2026.
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