Capricor Therapeutics' Duchenne Therapy Facility Inspection Completed by FDA

MT Newswires Live

Jun 11

Capricor Therapeutics (CAPR) expects its San Diego manufacturing facility for Deramiocel, a treatment for Duchenne muscular dystrophy, will meet license requirements following an early inspection by the US Food and Drug Administration.

The inspection resulted in routine observations related to quality systems and documentation, but no major changes to the facility or manufacturing process were required, the company said Wednesday in a statement.

Deramiocel's Biologics License Application remains under FDA priority review, with a target approval decision set for Aug. 31. A late-cycle meeting is planned for mid-July, and the FDA advisory committee will meet on July 30.

Capricor's shares fell 1.4% in recent trading Wednesday, paring earlier losses.

Price: 13.70, Change: -0.19, Percent Change: -1.37

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-web.itiger.com/news/2542753590"},"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:\"2542753590\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2542753590?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-06-11 23:27","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2542753590","market":"fut","top_or_hot":-1,"title":"Capricor Therapeutics' Duchenne Therapy Facility Inspection Completed by FDA","media":"MT Newswires Live","content":"<html><body><p> Capricor <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (CAPR) expects its San Diego manufacturing facility for Deramiocel, a treatment for Duchenne muscular dystrophy, will meet license requirements following an early inspection by the US Food and Drug Administration.</p><p>The inspection resulted in routine observations related to quality systems and documentation, but no major changes to the facility or manufacturing process were required, the company said Wednesday in a statement.</p><p>Deramiocel's Biologics License Application remains under FDA priority review, with a target approval decision set for Aug. 31. A late-cycle meeting is planned for mid-July, and the FDA advisory committee will meet on July 30.</p><p>Capricor's shares fell 1.4% in recent trading Wednesday, paring earlier losses.</p><p>Price: 13.70, Change: -0.19, Percent Change: -1.37</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>Capricor Therapeutics' Duchenne Therapy Facility Inspection Completed by FDA</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\">\nCapricor Therapeutics' Duchenne Therapy Facility Inspection Completed by FDA\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\">2025-06-11 23:27</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Capricor <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (CAPR) expects its San Diego manufacturing facility for Deramiocel, a treatment for Duchenne muscular dystrophy, will meet license requirements following an early inspection by the US Food and Drug Administration.</p><p>The inspection resulted in routine observations related to quality systems and documentation, but no major changes to the facility or manufacturing process were required, the company said Wednesday in a statement.</p><p>Deramiocel's Biologics License Application remains under FDA priority review, with a target approval decision set for Aug. 31. A late-cycle meeting is planned for mid-July, and the FDA advisory committee will meet on July 30.</p><p>Capricor's shares fell 1.4% in recent trading Wednesday, paring earlier losses.</p><p>Price: 13.70, Change: -0.19, Percent Change: -1.37</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2542753590","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2542753590","pubTimestamp":1749655670,"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":"Capricor Therapeutics (CAPR) expects its San Diego manufacturing facility for Deramiocel, a treatment for Duchenne muscular dystrophy, will meet license requirements following an early inspection by t","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","CAPR":"Capricor Therapeutics Inc"},"translate_title":"FDA完成Capricor Therapeutics杜兴治疗设施检查","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CAPR":1},"content_text":"Capricor Therapeutics (CAPR) expects its San Diego manufacturing facility for Deramiocel, a treatment for Duchenne muscular dystrophy, will meet license requirements following an early inspection by the US Food and Drug Administration.The inspection resulted in routine observations related to quality systems and documentation, but no major changes to the facility or manufacturing process were required, the company said Wednesday in a statement.Deramiocel's Biologics License Application remains under FDA priority review, with a target approval decision set for Aug. 31. A late-cycle meeting is planned for mid-July, and the FDA advisory committee will meet on July 30.Capricor's shares fell 1.4% in recent trading Wednesday, paring earlier losses.Price: 13.70, Change: -0.19, Percent Change: -1.37","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}