Cue Biopharma Receives FDA Feedback for Trial Design of Drug Candidate to Treat Autoimmune Diseases

MT Newswires Live

2025/06/25

Cue Biopharma (CUE) said late Tuesday it received pre-investigational new drug feedback from the US Food and Drug Administration on its trial design for the CUE-401 drug candidate to treat T-cell mediated autoimmune and inflammatory diseases.

As a result, the company said it plans to file an IND pending completion of final IND enabling studies.

The FDA review involves Cue Biopharma's plans for dose escalation, proposed populations, and safety monitoring strategy, according to a statement.

Shares were up 3.6% in after-hours trading.

免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。

熱議股票

{"basename":"/hant","ssrTDKData":{"titleTemplate":"%s - 老虎證券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎證券,老虎證券開戶,老虎券商,老虎證券官網,老虎證券app,tigertrade老虎證券,股票,炒股,新加坡股票交易平臺,投資,投資理財","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hant/news/2546255346"},"companyName":"老虎證券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2546255346\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2546255346?lang=zh_TW&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-06-25 05:01","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2546255346","market":"sh","top_or_hot":-1,"title":"Cue Biopharma Receives FDA Feedback for Trial Design of Drug Candidate to Treat Autoimmune Diseases","media":"MT Newswires Live","content":"<html><body><p> <a href=\"https://laohu8.com/S/CUE\">Cue Biopharma</a> (CUE) said late Tuesday it received pre-investigational new drug feedback from the US Food and Drug Administration on its trial design for the CUE-401 drug candidate to treat T-cell mediated autoimmune and inflammatory diseases.</p><p>As a result, the company said it plans to file an IND pending completion of final IND enabling studies.</p><p>The FDA review involves Cue Biopharma's plans for dose escalation, proposed populations, and safety monitoring strategy, according to a statement.</p><p>Shares were up 3.6% in after-hours trading.</p></body></html>","source":"mtnewswires_news","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>Cue Biopharma Receives FDA Feedback for Trial Design of Drug Candidate to Treat Autoimmune Diseases</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\">\nCue Biopharma Receives FDA Feedback for Trial Design of Drug Candidate to Treat Autoimmune Diseases\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time smaller\">2025-06-25 05:01</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<html><body><p> <a href=\"https://laohu8.com/S/CUE\">Cue Biopharma</a> (CUE) said late Tuesday it received pre-investigational new drug feedback from the US Food and Drug Administration on its trial design for the CUE-401 drug candidate to treat T-cell mediated autoimmune and inflammatory diseases.</p><p>As a result, the company said it plans to file an IND pending completion of final IND enabling studies.</p><p>The FDA review involves Cue Biopharma's plans for dose escalation, proposed populations, and safety monitoring strategy, according to a statement.</p><p>Shares were up 3.6% in after-hours trading.</p></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2546255346","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2546255346","pubTimestamp":1750798912,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Cue Biopharma  said late Tuesday it received pre-investigational new drug feedback from the US Food and Drug Administration on its trial design for the CUE-401 drug candidate to treat T-cell mediated autoimmune and inflammatory diseases.As a result, the company said it plans to file an IND pending completion of final IND enabling studies.The FDA review involves Cue Biopharma's plans for dose escalation, proposed populations, and safety monitoring strategy, according to a statement.Shares were up 3.6% in after-hours trading.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","CUE":"Cue Biopharma, Inc.","CUE.AU":"CUE ENERGY RESOURCES LIMITED","BK7142":"石油与天然气的勘探与生产"},"translate_title":"Cue Biopharma收到FDA关于治疗自身免疫性疾病候选药物试验设计的反馈","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CUE.AU":1,"CUE":0.9},"content_text":"Cue Biopharma (CUE) said late Tuesday it received pre-investigational new drug feedback from the US Food and Drug Administration on its trial design for the CUE-401 drug candidate to treat T-cell mediated autoimmune and inflammatory diseases.As a result, the company said it plans to file an IND pending completion of final IND enabling studies.The FDA review involves Cue Biopharma's plans for dose escalation, proposed populations, and safety monitoring strategy, according to a statement.Shares were up 3.6% in after-hours trading.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}