FDA Clinical Hold Knocks REGENXBIO Stock

Benzinga_recent_news01-29

REGENXBIO Inc. (NASDAQ:RGNX) shares are tumbling on Wednesday with a session volume of 3.83 million versus an average volume of 684.271 thousand. The move follows a regulatory update that has raised ...

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(NASDAQ:RGNX) shares are tumbling on Wednesday with a session volume of 3.83 million versus an average volume of 684.271 thousand.\nThe move follows a regulatory update that has raised ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/01/50199815/fda-clinical-hold-knocks-regenxbio-stock\">Source Link</a>\n\n</div>\n","source":"benzinga_recent_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>FDA Clinical Hold Knocks REGENXBIO Stock</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\">\nFDA Clinical Hold Knocks REGENXBIO Stock\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-01-29 01:31 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/fda/26/01/50199815/fda-clinical-hold-knocks-regenxbio-stock><strong>Benzinga_recent_news</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>REGENXBIO Inc. (NASDAQ:RGNX) shares are tumbling on Wednesday with a session volume of 3.83 million versus an average volume of 684.271 thousand.\nThe move follows a regulatory update that has raised ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/01/50199815/fda-clinical-hold-knocks-regenxbio-stock\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4563","symbol_name":"昨日强势股","start_time":0,"source_url":"https://www.benzinga.com/news/fda/26/01/50199815/fda-clinical-hold-knocks-regenxbio-stock","article_id":"2607774966","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2026/01/28/REGENXBIO-Inc.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/news/fda/26/01/50199815/fda-clinical-hold-knocks-regenxbio-stock","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2607774966","pubTimestamp":1769621460,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"REGENXBIO shares sink after the FDA places a clinical hold on two gene therapy trials following a safety concern tied to abnormal tissue growth in one patient.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4563":"昨日强势股","BK4139":"生物科技","BK4217":"自存仓储房地产信托","SMA":"Smartstop Self Storage REIT Inc","RGNX":"Regenxbio Inc","BK4505":"高瓴资本持仓"},"translate_title":"FDA临床搁置打击REGENXBIO股票","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SMA":1,"RGNX":1},"content_text":"REGENXBIO Inc. (NASDAQ:RGNX) shares are tumbling on Wednesday with a session volume of 3.83 million versus an average volume of 684.271 thousand.\nThe move follows a regulatory update that has raised concerns among investors. The U.S. Food and Drug Administration (FDA) placed a clinical hold on its investigational gene therapies.\nThe FDA’s decision affects REGENXBIO’s RGX-111 and RGX-121 programs, which are aimed at treating rare genetic disorders.\nThe clinical hold was prompted by a case of neoplasm detected in a participant treated with RGX-111, leading to scrutiny over the safety of both therapies.\nRGX-111 is under development for MPS I, also known as Hurler syndrome, which is an inherited condition caused by a faulty gene. Children with Hurler syndrome lack an enzyme that the body needs to digest sugar.\nA neoplasm is a new and abnormal growth of tissue in a part of the body, especially as a characteristic of cancer.\nThe FDA also placed a clinical hold on RGX-121 for MPS II, also known as Hunter Syndrome, citing the similarities in products, study populations, and shared risk between the clinical studies.\nChildren with Hunter syndrome lack an enzyme called iduronate 2-sulfatase that the body needs to digest sugar. As a result, undigested sugar molecules build up in the body.\nIn addition, the company reported that no evidence of neoplasm has been found in other participants treated with RGX-111 or RGX-121.\nREGENXBIO’s CEO expressed surprise at the FDA’s decision, emphasizing the favorable safety profile of RGX-121 based on data from over 30 patients treated, some nearly seven years ago.\nThe stock is currently trading 23.4% below its 20-day simple moving average (SMA) and 9.9% below its 100-day SMA, demonstrating significant short-term weakness. Over the past 12 months, shares have increased by 44.41% and are currently positioned closer to their 52-week lows than highs.\nThe RSI is at 45.56, which is considered neutral territory, while the MACD is below its signal line, indicating bearish pressure on the stock. The combination of neutral RSI and bearish MACD suggests mixed momentum.\nInvestors are looking ahead to the next earnings report on March 12, 2026.\nThe stock carries a Buy Rating with an average price target of $31.38. Recent analyst moves include:\nBelow is the Benzinga Edge scorecard for REGENXBIO, highlighting its strengths and weaknesses compared to the broader market:\nThe Verdict: REGENXBIO’s Benzinga Edge signal reveals a strong momentum score of 91.62, indicating that the stock is currently outperforming the broader market despite the recent regulatory challenges. Investors should remain cautious as the company addresses the FDA’s concerns while monitoring the stock’s performance closely.\nRGNX Price Action: Regenxbio shares were down 20.21% at $10.70 at the time of publication on Wednesday, according to Benzinga Pro data.\nPhoto via Shutterstock","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":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,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","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/2607774966","isCrawlerRequest":true}