Solid Biosciences Gains FDA Clearance for New Drug Application

Dow Jones

Jan 08, 2025

By Katherine Hamilton

Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.

The application is for SGT-212, designed to treat the degenerative disease Friedreich's ataxia. The drug is unique because it uses two routes of administration to address the illness in the cardiac region and the cerebellum.

The Charlestown, Mass.-based company expects to initiate a phase 1b clinical trial in the second half of 2025.

Shares climbed 20% to $4.70 in after-hours trading following the news.

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

(MORE TO FOLLOW) Dow Jones Newswires

January 07, 2025 16:40 ET (21:40 GMT)

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.

Most Discussed

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2501975381"},"companyName":"Tiger Brokers"},"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:\"2501975381\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2501975381?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-01-08 05:40","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2501975381","market":"nz","top_or_hot":-1,"title":"Solid Biosciences Gains FDA Clearance for New Drug Application","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Katherine Hamilton \n</p>\n<p>\n  <a href=\"https://laohu8.com/S/SLDB\">Solid Biosciences</a> received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday. \n</p>\n<p>\n  The application is for SGT-212, designed to treat the degenerative disease Friedreich's ataxia. The drug is unique because it uses two routes of administration to address the illness in the cardiac region and the cerebellum. \n</p>\n<p>\n  The Charlestown, Mass.-based company expects to initiate a phase 1b clinical trial in the second half of 2025. \n</p>\n<p>\n  Shares climbed 20% to $4.70 in after-hours trading following the news. \n</p>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (MORE TO FOLLOW) Dow Jones Newswires\n</p>\n<p>\n  January 07, 2025 16:40 ET (21:40 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>Solid Biosciences Gains FDA Clearance for New Drug Application</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\">\nSolid Biosciences Gains FDA Clearance for New Drug Application\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\">2025-01-08 05:40</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<p>\n  <a href=\"https://laohu8.com/S/SLDB\">Solid Biosciences</a> received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday. \n</p>\n<p>\n  The application is for SGT-212, designed to treat the degenerative disease Friedreich's ataxia. The drug is unique because it uses two routes of administration to address the illness in the cardiac region and the cerebellum. \n</p>\n<p>\n  The Charlestown, Mass.-based company expects to initiate a phase 1b clinical trial in the second half of 2025. \n</p>\n<p>\n  Shares climbed 20% to $4.70 in after-hours trading following the news. \n</p>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (MORE TO FOLLOW) Dow Jones Newswires\n</p>\n<p>\n  January 07, 2025 16:40 ET (21:40 GMT)\n</p>\n<p>\n  Copyright (c) 2025 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":"SLDB","symbol_name":"Solid Biosciences","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2501975381","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2501975381","pubTimestamp":1736286000,"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":"Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.The application is for SGT-212, designed to treat the degenerative disease Friedreich's ataxia. The drug is unique because it uses two routes of administration to address the illness in the cardiac region and the cerebellum.The Charlestown, Mass.-based company expects to initiate a phase 1b clinical trial in the second half of 2025.Shares climbed 20% to $4.70 in after-hours trading following the news.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"SLDB":"Solid Biosciences","BK4139":"生物科技"},"translate_title":"Solid Biosciences新药申请获得FDA批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SLDB":1},"content_text":"By Katherine Hamilton \n\n\nSolid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday. \n\n\n  The application is for SGT-212, designed to treat the degenerative disease Friedreich's ataxia. The drug is unique because it uses two routes of administration to address the illness in the cardiac region and the cerebellum. \n\n\n  The Charlestown, Mass.-based company expects to initiate a phase 1b clinical trial in the second half of 2025. \n\n\n  Shares climbed 20% to $4.70 in after-hours trading following the news. \n\n\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n\n\n \n\n\n  (MORE TO FOLLOW) Dow Jones Newswires\n\n\n  January 07, 2025 16:40 ET (21:40 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":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}