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ImmunityBio Reports Label Expansion and Additional Global Approval with Q3 2026 Net Product Revenue of $48.7 Million, Up 53% Year-Over-Year and First Nine Months U.S. Revenue Up 92% to $143.6 Million

IBRX
  • On October 14, 2026, the FDA approved a supplemental Biologics License Application to expand ANKTIVA's indication to include adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.
  • In November 2026, the primary endpoint for Cohort A was met in the QUILT-2.005 trial for BCG-naïve NMIBC, with an sBLA submission scheduled for the fourth quarter of 2026.
  • In November 2026, ANKTIVA received approval in Israel for BCG-unresponsive NMIBC, bringing the total number of global approvals to 35 jurisdictions.
  • In November 2026, the first patients in Europe received treatment with ANKTIVA for BCG-unresponsive NMIBC, expanding commercial access to the region.
  • The Emirates Drug Establishment authorized the expanded FDA indication, with further global filings planned for this new patient population.
  • In October 2026, long-term outcomes from the QUILT-3.032 trial were published in The Journal of Urology, showing an 84% cystectomy avoidance rate at 36 months for responders.
  • Third quarter 2026 net product revenue reached $48.7 million, representing a 53% year-over-year increase.
  • Year-to-date net product revenue for the first nine months of 2026 totaled $143.6 million, marking a 92% year-over-year growth.
  • As of September 30, 2026, the company held $334.3 million in cash, cash equivalents, and marketable securities.
  • Net loss for the three months ended September 30, 2026, was $184.6 million, driven by non-cash changes in liability fair values due to stock price increases.
  • Adjusted net loss for the three months ended September 30, 2026, increased to $97.9 million compared to $72.4 million in the prior year period.
  • Research and development expenses for the quarter increased to $71.5 million, primarily due to higher clinical trial costs.
  • Selling, general, and administrative expenses for the quarter rose to $54.0 million, attributed to increased professional services and commercial costs.
  • For the nine months ended September 30, 2026, the company reported a net loss of $1.0 billion, largely influenced by significant non-cash fair value adjustments.
  • Adjusted net loss for the nine-month period increased to $265.2 million, reflecting higher operating expenses.
  • ImmunityBio's ANKTIVA is now approved or authorized in six regulatory jurisdictions, covering a global footprint of 35 countries.