ImmunityBio Provides Regulatory Update on Global Submission for ANKTIVA + BCG in BCG Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in situ in Europe and United Kingdom

ImmunityBio, Inc. (NASDAQ: IBRX) today announced the completion of the submissions of its marketing authorization applications (MAA) for ANKTIVA (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to both the European Union (EU) European Medicines Agency (EMA) and the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA).

The EMA covers 27 countries in the EU, as well as Iceland, Norway, and Liechtenstein. The assessment is expected to be complete by the fourth quarter of 2025. Similarly, the UK assessment of the MAA is anticipated to be completed by the fourth quarter of 2025. ImmunityBio is in continued dialog for requests for information from the two agencies, with the potential of approval by 2026.

“The submission of our applications to EMA and MHRA represents a significant milestone in our efforts to address this critical need and improve patient outcomes globally,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.

ImmunityBio continues to make strides in its mission to provide innovative therapies for patients with limited treatment options. The U.S. launch of ANKTIVA for NMIBC CIS has gained momentum, with the product now widely accessible through commercial and government insurance programs. The company recently announced the unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9028) assigned by the Centers for Medicare & Medicaid Services (CMS) in the United States for ANKTIVA (nogapendekin alfa inbakicept-pmln) under J9028 (Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram). To date, commercial and governmental insurance cover over 240 million lives for ANKTIVA.

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.