Scholar Rock Plans Apitegromab Commercialization, Expanded Use in 2025

MT Newswires Live05:57

Scholar Rock (SRRK) said Wednesday it aims to submit a biologics license application in the US and a marketing authorization application in Europe for apitegromab to treat spinal muscular atrophy.

Applications with the US Food and Drug Administration and European Medicines Agency are expected in Q1 2025, and a US launch in Q4.

Scholar Rock also plans to focus on three key priorities in 2025, including commercialization, expanded use of apitegromab, and advancing anti-myostatin program for cardiometabolic disorders.

Key milestones for the company include starting the phase 2 trial in SMA patients under two years old by mid-2025, phase 2 obesity trial data in Q2, and filing an investigational new drug application for SRK-439 to treat obesity in Q3, Scholar Rock said.

Scholar Rock said its current cash and equivalent funds are enough to cover operation through Q4 2026.

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/2502086455?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-01-09 05:57","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2502086455","market":"sh","top_or_hot":-1,"title":"Scholar Rock Plans Apitegromab Commercialization, Expanded Use in 2025","media":"MT Newswires Live","content":"<html><body><p> Scholar Rock (SRRK) said Wednesday it aims to submit a biologics license application in the US and a marketing authorization application in Europe for apitegromab to treat spinal muscular atrophy.</p><p>Applications with the US Food and Drug Administration and European Medicines Agency are expected in Q1 2025, and a US launch in Q4.</p><p>Scholar Rock also plans to focus on three key priorities in 2025, including commercialization, expanded use of apitegromab, and advancing anti-myostatin program for cardiometabolic disorders.</p><p>Key milestones for the company include starting the phase 2 trial in SMA patients under two years old by mid-2025, phase 2 obesity trial data in Q2, and filing an investigational new drug application for SRK-439 to treat obesity in Q3, Scholar Rock said.</p><p>Scholar Rock said its current cash and equivalent funds are enough to cover operation through Q4 2026.</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>Scholar Rock Plans Apitegromab Commercialization, Expanded Use in 2025</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\">\nScholar Rock Plans Apitegromab Commercialization, Expanded Use in 2025\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-01-09 05:57 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.mtnewswires.com/><strong>MT Newswires Live</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Scholar Rock (SRRK) said Wednesday it aims to submit a biologics license application in the US and a marketing authorization application in Europe for apitegromab to treat spinal muscular atrophy....</p>\n\n<a href=\"https://www.mtnewswires.com/\">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":"SRRK","symbol_name":"Scholar Rock Holding Corp","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2502086455","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2502086455","pubTimestamp":1736373463,"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":"Scholar Rock (SRRK) said Wednesday it aims to submit a biologics license application in the US and a marketing authorization application in Europe for apitegromab to treat spinal muscular atrophy.Appl","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"SRRK":"Scholar Rock Holding Corp","BK4139":"生物科技"},"translate_title":"Scholar Rock计划2025年实现Apitegromab商业化并扩大使用","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SRRK":0.9},"content_text":"Scholar Rock (SRRK) said Wednesday it aims to submit a biologics license application in the US and a marketing authorization application in Europe for apitegromab to treat spinal muscular atrophy.Applications with the US Food and Drug Administration and European Medicines Agency are expected in Q1 2025, and a US launch in Q4.Scholar Rock also plans to focus on three key priorities in 2025, including commercialization, expanded use of apitegromab, and advancing anti-myostatin program for cardiometabolic disorders.Key milestones for the company include starting the phase 2 trial in SMA patients under two years old by mid-2025, phase 2 obesity trial data in Q2, and filing an investigational new drug application for SRK-439 to treat obesity in Q3, Scholar Rock said.Scholar Rock said its current cash and equivalent funds are enough to cover operation through Q4 2026.","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":"productRelease","news_rank":0,"symbols":[],"gpt_button":1},"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":"4.30.0","shortVersion":"4.30.0","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/2502086455"}