ImmunityBio Reports 700% Revenue Growth, Global ANKTIVA Approvals, and First Lung Cancer Indication

summarizeSummary

ImmunityBio announced strong full-year 2025 financial results with 700% revenue growth for ANKTIVA, expanded global regulatory approvals, and a significant first approval for lung cancer in Saudi Arabia.

check_boxKey Events

• Strong ANKTIVA Revenue Growth

  ImmunityBio reported $113 million in net product revenue for ANKTIVA for full-year 2025, representing an approximately 700% increase year-over-year. Q4 2025 net product revenue increased 20% quarter-over-quarter to $38.3 million.

• Expanded Global Approvals for Bladder Cancer

  ANKTIVA in combination with BCG for BCG-unresponsive NMIBC CIS is now authorized across four major regulatory jurisdictions: United States, United Kingdom, European Union (covering 27 member states plus Iceland, Norway, and Liechtenstein), and Saudi Arabia, encompassing 33 countries in total.

• First Approval for Lung Cancer

  The Saudi Food and Drug Authority (SFDA) granted conditional accelerated approval for ANKTIVA in combination with checkpoint inhibitors for the treatment of metastatic non-small cell lung cancer, marking the first global authorization for ANKTIVA outside of bladder cancer. Commercial launch in Saudi Arabia is planned within 60 days.

• Improved Financial Position

  The company reduced its net loss attributable to common stockholders to $351.4 million for full-year 2025, down from $413.6 million in 2024. ImmunityBio ended 2025 with $242.8 million in consolidated cash, cash equivalents, and marketable securities.

auto_awesomeAnalysis

This filing provides a highly positive business update for ImmunityBio, highlighting significant commercial momentum and regulatory expansion for its key product, ANKTIVA. The reported 700% year-over-year revenue growth for ANKTIVA, reaching $113 million in 2025, demonstrates strong market adoption. Crucially, the company secured its first approval for ANKTIVA in lung cancer (metastatic NSCLC) in Saudi Arabia, marking a significant label expansion beyond bladder cancer and validating the drug's broader potential. Expanded global authorizations for bladder cancer in the EU and Saudi Arabia further broaden market access. The reduction in net loss and a solid cash position also indicate improving financial health, supporting continued clinical development and commercialization efforts.