Aardvark Therapeutics Says FDA Placed Hold on ARD-101 Trials

Dow Jones05-15

By Katherine Hamilton

Aardvark Therapeutics' drug application for ARD-101, a treatment for people with the genetic disorder Prader-Willi Syndrome, was placed on clinical hold by the Food and Drug Administration.

The clinical-stage biopharmaceutical company said after the close Thursday the hold applies to all ongoing clinical studies under the application, including two Phase 3 trials.

Shares slid 14% to $5.82 in post-market trading.

The hold was related to Aardvark's voluntary pause of one of the Phase 3 trials in February, which it said at the time was due to safety issues in the study.

Aardvark is in talks with the FDA to resolve the hold and determine a path forward for ARD-101, it said. The company also plans to unblind the clinical data from both trials to assess efficacy and safety, which it said will help decide next steps for the program.

ARD-101 is designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

May 14, 2026 17:08 ET (21:08 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

At the request of the copyright holder, you need to log in to view this content

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/2635117729?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-05-15 05:08","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2635117729","market":"hk","top_or_hot":-1,"title":"Aardvark Therapeutics Says FDA Placed Hold on ARD-101 Trials","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Katherine Hamilton \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  <a href=\"https://laohu8.com/S/AARD\">Aardvark Therapeutics</a>' drug application for ARD-101, a treatment for people with the genetic disorder Prader-Willi Syndrome, was placed on clinical hold by the Food and Drug Administration. \n</p>\n<p>\n  The clinical-stage biopharmaceutical company said after the close Thursday the hold applies to all ongoing clinical studies under the application, including two Phase 3 trials. \n</p>\n<p>\n  Shares slid 14% to $5.82 in post-market trading. \n</p>\n<p>\n  The hold was related to Aardvark's voluntary pause of one of the Phase 3 trials in February, which it said at the time was due to safety issues in the study. \n</p>\n<p>\n  Aardvark is in talks with the FDA to resolve the hold and determine a path forward for ARD-101, it said. The company also plans to unblind the clinical data from both trials to assess efficacy and safety, which it said will help decide next steps for the program. \n</p>\n<p>\n  ARD-101 is designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 14, 2026 17:08 ET (21:08 GMT)\n</p>\n<p>\n  Copyright (c) 2026 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>Aardvark Therapeutics Says FDA Placed Hold on ARD-101 Trials</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\">\nAardvark Therapeutics Says FDA Placed Hold on ARD-101 Trials\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\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\">2026-05-15 05:08</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Katherine Hamilton \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  <a href=\"https://laohu8.com/S/AARD\">Aardvark Therapeutics</a>' drug application for ARD-101, a treatment for people with the genetic disorder Prader-Willi Syndrome, was placed on clinical hold by the Food and Drug Administration. \n</p>\n<p>\n  The clinical-stage biopharmaceutical company said after the close Thursday the hold applies to all ongoing clinical studies under the application, including two Phase 3 trials. \n</p>\n<p>\n  Shares slid 14% to $5.82 in post-market trading. \n</p>\n<p>\n  The hold was related to Aardvark's voluntary pause of one of the Phase 3 trials in February, which it said at the time was due to safety issues in the study. \n</p>\n<p>\n  Aardvark is in talks with the FDA to resolve the hold and determine a path forward for ARD-101, it said. The company also plans to unblind the clinical data from both trials to assess efficacy and safety, which it said will help decide next steps for the program. \n</p>\n<p>\n  ARD-101 is designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 14, 2026 17:08 ET (21:08 GMT)\n</p>\n<p>\n  Copyright (c) 2026 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":"LABU","symbol_name":"三倍做多标普生物-Direxion","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2635117729","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2635117729","pubTimestamp":1778792880,"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":"Aardvark Therapeutics' drug application for ARD-101, a treatment for people with the genetic disorder Prader-Willi Syndrome, was placed on clinical hold by the Food and Drug Administration.The clinical-stage biopharmaceutical company said after the close Thursday the hold applies to all ongoing clinical studies under the application, including two Phase 3 trials.Shares slid 14% to $5.82 in post-market trading.The hold was related to Aardvark's voluntary pause of one of the Phase 3 trials in February, which it said at the time was due to safety issues in the study.Aardvark is in talks with the FDA to resolve the hold and determine a path forward for ARD-101, it said. The company also plans to unblind the clinical data from both trials to assess efficacy and safety, which it said will help decide next steps for the program.ARD-101 is designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LABU":"三倍做多标普生物-Direxion","AARD":"Aardvark Therapeutics","BK4007":"制药","BK4588":"碎股","BK4585":"ETF&股票定投概念"},"translate_title":"Aardvark Therapeutics表示FDA暂停ARD-101试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AARD":1.5,"ARD":1.5,"LABU":1.5},"content_text":"By Katherine Hamilton \n\n\n \n\n\nAardvark Therapeutics' drug application for ARD-101, a treatment for people with the genetic disorder Prader-Willi Syndrome, was placed on clinical hold by the Food and Drug Administration. \n\n\n  The clinical-stage biopharmaceutical company said after the close Thursday the hold applies to all ongoing clinical studies under the application, including two Phase 3 trials. \n\n\n  Shares slid 14% to $5.82 in post-market trading. \n\n\n  The hold was related to Aardvark's voluntary pause of one of the Phase 3 trials in February, which it said at the time was due to safety issues in the study. \n\n\n  Aardvark is in talks with the FDA to resolve the hold and determine a path forward for ARD-101, it said. The company also plans to unblind the clinical data from both trials to assess efficacy and safety, which it said will help decide next steps for the program. \n\n\n  ARD-101 is designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. \n\n\n \n\n\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 14, 2026 17:08 ET (21:08 GMT)\n\n\n  Copyright (c) 2026 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":"-1","news_tag":"policyRegulatory","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":true,"need_login_tip":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,"isLaohu8Offline":false,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.44.0","shortVersion":"4.44.0","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/2635117729","isCrawlerRequest":true}