ImmunityBio Slides Following FDA Refusal-to-File Letter

Dow Jones

05/06

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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The intraday low was $2. \n</p>\n<p>\n  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. \n</p>\n<p>\n  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. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 05, 2025 13:05 ET (17:05 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IBRX","symbol_name":"ImmunityBio, Inc.","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2533538665","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2533538665","pubTimestamp":1746464700,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"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. 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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. \n\n\n  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. \n\n\n \n\n\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 05, 2025 13:05 ET (17:05 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}