Corcept Therapeutics' Relacorilant Faces Setback as FDA Issues Complete Response Letter on Hypertension Treatment

MT Newswires Live2025-12-31

Corcept Therapeutics (CORT) said Wednesday that the Food and Drug Administration (FDA) issued a Complete Response Letter for its New Drug Application seeking approval of relacorilant to treat hypertension secondary to hypercortisolism.

The company said that while the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial were confirmatory, it determined additional evidence of effectiveness is needed to support a favorable benefit-risk assessment.

"We are surprised and disappointed by this outcome," said CEO Joseph K. Belanoff, MD, adding that the company "will meet with the FDA promptly to determine the best path forward."

Relacorilant is an oral selective glucocorticoid receptor antagonist, in development for endogenous hypercortisolism including ovarian cancer and other disorders.

Shares of Corcept Therapeutics were down more than 4% in recent premarket trading.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2595542774?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-12-31 21:27","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2595542774","market":"nz","top_or_hot":-1,"title":"Corcept Therapeutics' Relacorilant Faces Setback as FDA Issues Complete Response Letter on Hypertension Treatment","media":"MT Newswires Live","content":"<html><body><p> Corcept <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (CORT) said Wednesday that the Food and Drug Administration (FDA) issued a Complete Response Letter for its New Drug Application seeking approval of relacorilant to treat hypertension secondary to hypercortisolism.</p><p>The company said that while the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial were confirmatory, it determined additional evidence of effectiveness is needed to support a favorable benefit-risk assessment.</p><p>\"We are surprised and disappointed by this outcome,\" said CEO Joseph <a href=\"https://laohu8.com/S/TKKD.SI\">K</a>. Belanoff, MD, adding that the company \"will meet with the FDA promptly to determine the best path forward.\"</p><p>Relacorilant is an oral selective glucocorticoid receptor antagonist, in development for endogenous hypercortisolism including ovarian cancer and other disorders.</p><p>Shares of Corcept Therapeutics were down more than 4% in recent premarket 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>Corcept Therapeutics' Relacorilant Faces Setback as FDA Issues Complete Response Letter on Hypertension Treatment</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: 11px; color: #7E829C; margin: 0;line-height: 11px;}\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\">\nCorcept Therapeutics' Relacorilant Faces Setback as FDA Issues Complete Response Letter on Hypertension Treatment\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\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\">2025-12-31 21:27</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Corcept <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (CORT) said Wednesday that the Food and Drug Administration (FDA) issued a Complete Response Letter for its New Drug Application seeking approval of relacorilant to treat hypertension secondary to hypercortisolism.</p><p>The company said that while the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial were confirmatory, it determined additional evidence of effectiveness is needed to support a favorable benefit-risk assessment.</p><p>\"We are surprised and disappointed by this outcome,\" said CEO Joseph <a href=\"https://laohu8.com/S/TKKD.SI\">K</a>. Belanoff, MD, adding that the company \"will meet with the FDA promptly to determine the best path forward.\"</p><p>Relacorilant is an oral selective glucocorticoid receptor antagonist, in development for endogenous hypercortisolism including ovarian cancer and other disorders.</p><p>Shares of Corcept Therapeutics were down more than 4% in recent premarket trading.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2595542774","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2595542774","pubTimestamp":1767187648,"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":"Corcept Therapeutics (CORT) said Wednesday that the Food and Drug Administration (FDA) issued a Complete Response Letter for its New Drug Application seeking approval of relacorilant to treat hyperten","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","LU1559883803.SGD":"Aberdeen Standard SICAV I - North American Smaller Companies Fund A Acc SGD-H","CORT":"Corcept医疗","LU0566484027.USD":"安本美国小盘成长股","BK4532":"文艺复兴科技持仓"},"translate_title":"FDA发布高血压治疗完整回复函Corcept Therapeutics的Relacorilant面临挫折","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CORT":1.5},"content_text":"Corcept Therapeutics (CORT) said Wednesday that the Food and Drug Administration (FDA) issued a Complete Response Letter for its New Drug Application seeking approval of relacorilant to treat hypertension secondary to hypercortisolism.The company said that while the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial were confirmatory, it determined additional evidence of effectiveness is needed to support a favorable benefit-risk assessment.\"We are surprised and disappointed by this outcome,\" said CEO Joseph K. Belanoff, MD, adding that the company \"will meet with the FDA promptly to determine the best path forward.\"Relacorilant is an oral selective glucocorticoid receptor antagonist, in development for endogenous hypercortisolism including ovarian cancer and other disorders.Shares of Corcept Therapeutics were down more than 4% in recent premarket 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":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.35.13","shortVersion":"4.35.13","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2595542774","isCrawlerRequest":true}