ImmunityBio Stock Climbs As FDA Accepts Expanded Use Filing For Bladder Cancer Drug

ImmunityBio Inc. (NASDAQ:IBRX) stock is up during Wednesday’s premarket session as the company is gaining attention following the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for ANKTIVA in combination with Bacillus Calmette-Guerin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

IBRX Jumps After FDA Accepts ANKTIVA sBLA For NMIBC

The FDA has accepted ImmunityBio’s sBLA for ANKTIVA, which is aimed at expanding treatment options for patients with BCG-unresponsive NMIBC.

The FDA assigned a PDUFA target action date of Jan. 6, 2027, indicating a significant step forward for the company’s product pipeline.

The supplemental application is supported by data from the QUILT 3.032 Phase 2/3 trial in 80 patients. The study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2%.

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ImmunityBio Stock Climbs As FDA Accepts Expanded Use Filing For Bladder Cancer Drug

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