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Biotech / Medical : ImmunityBio converts from Immunomedics
IBRX 2.139+0.9%Nov 7 9:30 AM EST
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From: zagnut12/14/2025 10:14:39 AM
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CULVER CITY, Calif.--(BUSINESS WIRE)--Feb. 13, 2025-- ImmunityBio, Inc. ( NASDAQ: IBRX), a leading immunity therapy company, today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA. The MHRA will now begin assessing the marketing authorization application (MAA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. MHRA regulates medicines, medical devices and blood components for transfusion in the UK.

“MHRA’s acceptance of our marketing authorization application for the UK comes less than three weeks after the European Medicines Agency accepted for review our MAA for the 30 countries covering the European Union, and just 10 months after FDA approval in the United States,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “We are determined to reach as many patients as possible with ANKTIVA and BCG and are encouraged by the momentum of our efforts.”
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