ImmunityBio Shares Rally as FDA Accepts N-803 Resubmission

By Colin Kellaher

ImmunityBio shares rose sharply Thursday after the clinical-stage immunotherapy company said the U.S. Food and Drug Administration accepted its resubmitted application seeking approval of N-803 in certain patients with bladder cancer.

Shares of the San Diego company were recently changing hands at $1.90, up 20%.

ImmunityBio, which is seeking FDA approval of N-803 in combination with Bacillus Calmette-Guerin, or BCG, for the treatment of certain patients with BCG-unresponsive non-muscle invasive bladder cancer, said the agency set a new target action date of April 23, 2024, for the application.

The FDA in May turned away ImmunityBio's initial application, flagging deficiencies related to its inspection of the company's third-party contract-manufacturing organizations and providing recommendations regarding additional chemistry, manufacturing and controls issues and assays to be resolved.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

10-26-23 1148ET