ImmunityBio Shares Plummet Premarket as FDA Turns Away Anktiva
11 May 2023 - 11:22PM
Dow Jones News
By Colin Kellaher
ImmunityBio Inc. shares plunged in premarket trading Thursday
after the clinical-stage immunotherapy company said the U.S. Food
and Drug Administration had rejected its application seeking
approval of its Anktiva product candidate in a form of bladder
cancer.
Shares of the San Diego company, which closed Wednesday at
$6.22, were recently down 51% to $3.06 in premarket trading.
ImmunityBio, which was seeking FDA approval of Anktiva in
combination with Bacillus Calmette-Guerin, or BCG, for the
treatment of certain patients with BCG-unresponsive non-muscle
invasive bladder cancer, said it received a so-called complete
response letter, indicating the agency won't approve the
application in its current form.
ImmunityBio said the FDA flagged deficiencies related to its
inspection of the company's third-party contract-manufacturing
organizations, and that the agency also provided recommendations
regarding additional chemistry, manufacturing and controls issues
and assays to be resolved.
The company noted that the FDA didn't request any new
preclinical studies or Phase 3 clinical trials, adding that it
plans to meet with the agency as soon as possible to address the
issues and a response timeline.
ImmunityBio, which previously said it was exploring a
partnership with a large biopharmaceutical company for
commercialization of Anktiva, said it is still in talks with the
potential partner despite the FDA setback, and that it aims to
complete a transaction this year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 11, 2023 09:07 ET (13:07 GMT)
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