Capricor Completes BLA Submission for Deramiocel to Treat DMD Cardiomyopathy

MT Newswires Live

Jan 02, 2025

Capricor Therapeutics (CAPR) said Thursday it has completed its biologics license application submission for deramiocel, which is intended to treat patients with Duchenne muscular dystrophy, or DMD, cardiomyopathy.

The company said it will receive a $10 million payment from its distribution partner, Nippon Shinyaku, as part of their US commercialization and distribution agreement.

Capricor has requested priority review, which could shorten the FDA review timeline from 10 months to six months after submission acceptance, the company said, adding that if deramiocel gains the FDA approval for DMD cardiomyopathy treatment, Capricor would also qualify for a priority review voucher due to its rare pediatric disease designation.

Shares of the company rose over 1% in recent Thursday trading.

Price: 14.00, Change: +0.19, Percent Change: +1.41

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/2500298920"},"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:\"2500298920\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2500298920?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-01-02 23:13","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2500298920","market":"sh","top_or_hot":-1,"title":"Capricor Completes BLA Submission for Deramiocel to Treat DMD Cardiomyopathy","media":"MT Newswires Live","content":"<html><body><p> Capricor <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (CAPR) said Thursday it has completed its biologics license application submission for deramiocel, which is intended to treat patients with Duchenne muscular dystrophy, or DMD, cardiomyopathy.</p><p>The company said it will receive a $10 million payment from its distribution partner, Nippon Shinyaku, as part of their US commercialization and distribution agreement.</p><p>Capricor has requested priority review, which could shorten the FDA review timeline from 10 months to six months after submission acceptance, the company said, adding that if deramiocel gains the FDA approval for DMD cardiomyopathy treatment, Capricor would also qualify for a priority review voucher due to its rare pediatric disease designation.</p><p>Shares of the company rose over 1% in recent Thursday trading.</p><p>Price: 14.00, Change: +0.19, Percent Change: +1.41</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 Completes BLA Submission for Deramiocel to Treat DMD Cardiomyopathy</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 Completes BLA Submission for Deramiocel to Treat DMD Cardiomyopathy\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\">2025-01-02 23:13</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) said Thursday it has completed its biologics license application submission for deramiocel, which is intended to treat patients with Duchenne muscular dystrophy, or DMD, cardiomyopathy.</p><p>The company said it will receive a $10 million payment from its distribution partner, Nippon Shinyaku, as part of their US commercialization and distribution agreement.</p><p>Capricor has requested priority review, which could shorten the FDA review timeline from 10 months to six months after submission acceptance, the company said, adding that if deramiocel gains the FDA approval for DMD cardiomyopathy treatment, Capricor would also qualify for a priority review voucher due to its rare pediatric disease designation.</p><p>Shares of the company rose over 1% in recent Thursday trading.</p><p>Price: 14.00, Change: +0.19, Percent Change: +1.41</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":"2500298920","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2500298920","pubTimestamp":1735830786,"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  said Thursday it has completed its biologics license application submission for deramiocel, which is intended to treat patients with Duchenne muscular dystrophy, or DMD, cardiomyopathy.The company said it will receive a $10 million payment from its distribution partner, Nippon Shinyaku, as part of their US commercialization and distribution agreement.Capricor has requested priority review, which could shorten the FDA review timeline from 10 months to six months after submission acceptance, the company said, adding that if deramiocel gains the FDA approval for DMD cardiomyopathy treatment, Capricor would also qualify for a priority review voucher due to its rare pediatric disease designation.Shares of the company rose over 1% in recent Thursday trading.Price: 14.00, Change: +0.19, Percent Change: +1.41","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","CAPR":"Capricor Therapeutics Inc"},"translate_title":"Capricor完成Deramiocel治疗DMD心肌病的BLA提交","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CAPR":0.9},"content_text":"Capricor Therapeutics (CAPR) said Thursday it has completed its biologics license application submission for deramiocel, which is intended to treat patients with Duchenne muscular dystrophy, or DMD, cardiomyopathy.The company said it will receive a $10 million payment from its distribution partner, Nippon Shinyaku, as part of their US commercialization and distribution agreement.Capricor has requested priority review, which could shorten the FDA review timeline from 10 months to six months after submission acceptance, the company said, adding that if deramiocel gains the FDA approval for DMD cardiomyopathy treatment, Capricor would also qualify for a priority review voucher due to its rare pediatric disease designation.Shares of the company rose over 1% in recent Thursday trading.Price: 14.00, Change: +0.19, Percent Change: +1.41","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":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}