ImmunityBio Shares Plummet Premarket as FDA Turns Away Anktiva

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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