The FDA accepted ImmunityBio’s supplemental Biologics License Application (sBLA) for ANKTIVA. The application seeks to expand the drug's use in combination with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease. This patient group represents approximately 85% of all NMIBC diagnoses in the United States.
The FDA established a PDUFA target action date of January 6, 2027. This regulatory progress follows a previous refusal-to-file setback for a similar application.
ImmunityBio (IBRX) shares jumped 3% in overnight trading leading into Wednesday, May 20. The market reaction followed the company's announcement after the Tuesday market close.