ImmunityBio Shares Rally as FDA Accepts N-803 Resubmission
October 26 2023 - 12:03PM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 26, 2023 11:48 ET (15:48 GMT)
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