Saudi FDA Grants Accelerated Approval to ImmunityBio's ANKTIVA® for Non-Muscle Invasive Bladder Cancer with Carcinoma In-Situ [Yahoo! Finance]
ImmunityBio, Inc. (IBRX)
Company Research
Source: Yahoo! Finance
Adding 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 option Enrollment 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., January 14, 2026 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 carcinoma in situ , with or without papillary disease. This regulatory action by the SFDA adds to the existing approvals in the United States and United Kingdom, as well as conditi
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News
- ImmunityBio Reports Continued Execution and Sales Momentum With $113 Million of Preliminary Net Product Revenue—a 700% increase year-over-year [Yahoo! Finance]Yahoo! Finance
- Stock Market Today, Jan. 15: ImmunityBio Surges After Anktiva Revenue Jumps 700% [Yahoo! Finance]Yahoo! Finance
- ImmunityBio: Why I Am Upgrading To A Buy For 2026 [Seeking Alpha]Seeking Alpha
- ImmunityBio Reports Continued Execution and Sales Momentum With $113 Million of Preliminary Net Product Revenue—a 700% increase year-over-yearBusiness Wire
- Update: ImmunityBio Gets Approval From Saudi FDA For Non-Muscle Invasive Bladder Cancer Treatment; Shares Rise [Yahoo! Finance]Yahoo! Finance
IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 1/15/26 - Form 8-K
- 1/14/26 - Form 8-K
- 1/5/26 - Form 4
- IBRX's page on the SEC website