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09 November
ImmunityBio, Inc. Reports Q3 2026 Net Product Revenue of $48.7 Million and FDA Label Expansion for ANKTIVA

ImmunityBio, Inc. reported its financial results for the third quarter ended September 30, 2026, with net product revenue reaching $48.7 million, representing a 53% increase year-over-year. For the first nine months of 2026, net product revenue totaled $143.6 million, up 92% compared with the first nine months of 2025. As of September 30, 2026, the company had cash and cash equivalents, and marketable securities of $334.3 million.

On October 14, 2026, the U.S. Food and Drug Administration approved the company's supplemental Biologics License Application expanding the approved indication for ANKTIVA in combination with Bacillus Calmette-Guérin to include adult patients with BCG-unresponsive non-muscle invasive bladder cancer. This expanded indication now includes adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.

In November 2026, ImmunityBio reported that the primary endpoint for Cohort A was met in the randomized QUILT-2.005 trial. The company remains on track to submit a supplemental Biologics License Application to the FDA in the fourth quarter of 2026 for ANKTIVA in combination with BCG in patients with BCG-naïve non-muscle invasive bladder cancer.

Additionally, in November 2026, ImmunityBio announced the approval in Israel of ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors, bringing the number of global approvals to 35. The company also announced that the first patients in Europe have received treatment with ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors, expanding access to ANKTIVA across the region.

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This story originally appeared on Fintel.