Scholar Rock Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date

MT Newswires Live

Aug 08

Scholar Rock Holding (SRRK) said the FDA review of its apitegromab Biologics License Application for spinal muscular atrophy remains on track for potential approval by the September 30 PDUFA date, with the review now progressing solely with the company's second fill-finish facility.

The company said it received notification on August 7 that the FDA classified an April 2026 inspection of Catalent Indiana, one of two fill-finish facilities included in the March 2026 BLA submission, as Official Action Indicated, and it will remove Catalent Indiana from the application.

Scholar Rock said the data package required for FDA review of the second facility was submitted ahead of schedule, with commercial supply already awaiting packaging and labeling at a third-party site.

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.0a0bd8dc.png","ogUrl":"https://www.itiger.com/news/2657629325"},"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:\"2657629325\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2657629325?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-08-08 04:46","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2657629325","market":"sg","top_or_hot":-1,"title":"Scholar Rock Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date","media":"MT Newswires Live","content":"<html><body><p> <a href=\"https://laohu8.com/S/SRRK\">Scholar Rock</a> Holding (SRRK) said the FDA review of its apitegromab Biologics License Application for spinal muscular atrophy remains on track for potential approval by the September 30 PDUFA date, with the review now progressing solely with the company's second fill-finish facility.</p><p>The company said it received notification on August 7 that the FDA classified an April 2026 inspection of Catalent Indiana, one of two fill-finish facilities included in the March 2026 BLA submission, as Official Action Indicated, and it will remove Catalent Indiana from the application.</p><p>Scholar Rock said the data package required for FDA review of the second facility was submitted ahead of schedule, with commercial supply already awaiting packaging and labeling at a third-party site.</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 Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date</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 Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date\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\">2026-08-08 04:46</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> <a href=\"https://laohu8.com/S/SRRK\">Scholar Rock</a> Holding (SRRK) said the FDA review of its apitegromab Biologics License Application for spinal muscular atrophy remains on track for potential approval by the September 30 PDUFA date, with the review now progressing solely with the company's second fill-finish facility.</p><p>The company said it received notification on August 7 that the FDA classified an April 2026 inspection of Catalent Indiana, one of two fill-finish facilities included in the March 2026 BLA submission, as Official Action Indicated, and it will remove Catalent Indiana from the application.</p><p>Scholar Rock said the data package required for FDA review of the second facility was submitted ahead of schedule, with commercial supply already awaiting packaging and labeling at a third-party site.</p></body></html>\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":"2657629325","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2657629325","pubTimestamp":1786135593,"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 Holding (SRRK) said the FDA review of its apitegromab Biologics License Application for spinal muscular atrophy remains on track for potential approval by the September 30 PDUFA date, wit","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"SRRK":"Scholar Rock Holding Corp","IBRN":"iShares Neuroscience and Healthcare ETF","BK4139":"生物科技","THNR":"AMPLIFY WEIGHT LOSS DRUG & TREATMENT ETF"},"translate_title":"Scholar Rock Holding 表示 Apitegromab BLA 审查将于 9 月 30 日 PDUFA 日期按计划进行","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IBRN":0.6,"THNR":0.6,"SRRK":1},"content_text":"Scholar Rock Holding (SRRK) said the FDA review of its apitegromab Biologics License Application for spinal muscular atrophy remains on track for potential approval by the September 30 PDUFA date, with the review now progressing solely with the company's second fill-finish facility.The company said it received notification on August 7 that the FDA classified an April 2026 inspection of Catalent Indiana, one of two fill-finish facilities included in the March 2026 BLA submission, as Official Action Indicated, and it will remove Catalent Indiana from the application.Scholar Rock said the data package required for FDA review of the second facility was submitted ahead of schedule, with commercial supply already awaiting packaging and labeling at a third-party site.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}