Saudi FDA Grants Accelerated Approval to ImmunityBio’s ANKTIVA® for Non-Muscle Invasive Bladder Cancer with Carcinoma In-Situ
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
Approval of ANKTIVA was granted for BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary disease, based on review of data from QUILT-3.032Adding to existing ANKTIVA NMIBC approvals in the U.S. and U.K., and conditional approval in the European Union, the SFDA’s action reflects ImmunityBio’s mission to provide access to patients globally with a potentially bladder surgery-sparing optionEnrollment in randomized trial of ANKTIVA in BCG naïve NMIBC patients is ahead of schedule with full enrollment anticipated by Q2 2026 and BLA submission targeted by year-end CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the Saudi Food and Drug Authority (SFDA) has granted approval of ANKTIVA® (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcino
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Sec Filings
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- 1/15/26 - Form 8-K
- 1/14/26 - Form 8-K
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