ImmunityBio, Inc. (NASDAQ: IBRX) saw its shares soar 5.14% in pre-market trading on Thursday, reflecting strong investor optimism.
The surge follows the company's announcement that it has completed enrollment ahead of schedule in its Phase 2 QUILT 2.005 randomized trial evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG versus BCG alone in BCG-naïve non-muscle invasive bladder cancer carcinoma in situ. An interim analysis requested by the U.S. Food and Drug Administration showed a statistically significant improvement in the duration of complete response for the combination therapy, with 85% of patients on ANKTIVA plus BCG maintaining a complete response at six months versus 57% on BCG alone. The positive results were sustained at nine months, with 84% versus 52%, respectively, and no significant safety signals were observed.
This clinical progress is bolstered by the company's anticipation of submitting a Biologics License Application for ANKTIVA to the FDA by the fourth quarter of 2026. The pre-market movement also builds on positive momentum from the previous session, where the stock rallied following the release of strong financial results and a strategic partnership for Anktiva's commercialization.