ImmunityBio Slides Following FDA Refusal-to-File Letter

Dow Jones

May 06

By Josh Beckerman

Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for bladder-cancer treatment Anktiva.

The stock was down 19%, to $2.04, midday Monday and has fallen about 20% this year. The intraday low was $2.

The company said it requested an urgent meeting with the FDA. It said the letter was inconsistent from the unanimous guidance and encouragement it received from FDA leadership at a January meeting, and that a delay is harmful to patients who have a disease with a high risk of morbidity and mortality.

ImmunityBio submitted the application for use of Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer for the indication of papillary disease. The drug was approved in April 2024 for certain bladder-cancer patients.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

May 05, 2025 13:05 ET (17:05 GMT)

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