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)

Copyright (c) 2025 Dow Jones & Company, Inc.

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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>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>ImmunityBio Slides Following FDA Refusal-to-File Letter</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nImmunityBio Slides Following FDA Refusal-to-File Letter\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Dow Jones </p>\n<p class=\"h-time smaller\">2025-05-06 01:05</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Josh Beckerman \n</p>\n<pre>\n \n</pre>\n<p>\n  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. \n</p>\n<p>\n  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"}}}