FDA Requests Additional HOPE-3 Data for Capricor's Deramiocel Approval Review

Reuters

Jan 20

FDA Requests Additional HOPE-3 Data for Capricor's Deramiocel Approval Review

Capricor Therapeutics Inc. is facing a regulatory issue related to its Biologics License Application (BLA) for Deramiocel, a cell therapy for Duchenne muscular dystrophy. Following a Complete Response Letter $(CRL)$ from the FDA in July 2025, the agency has requested the full clinical study report from the HOPE-3 Phase 3 trial as part of its review process. Capricor plans to submit the required updates to the BLA in February 2026 to support continued FDA evaluation, which may impact the timing of potential approval and market access for Deramiocel.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capricor Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9628399) on January 20, 2026, and is solely responsible for the information contained therein.

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

1
2
3
4
5
6
7
8
9
10

{"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/2604465119"},"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:\"2604465119\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2604465119?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-01-20 22:15","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2604465119","market":"us","top_or_hot":-1,"title":"FDA Requests Additional HOPE-3 Data for Capricor's Deramiocel Approval Review","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Requests Additional HOPE-3 Data for Capricor's Deramiocel Approval Review\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/CAPR\">Capricor Therapeutics Inc</a>. is facing a regulatory issue related to its Biologics License Application (BLA) for Deramiocel, a cell therapy for Duchenne muscular dystrophy. Following a Complete Response Letter <a href=\"https://laohu8.com/S/CRL\">$(CRL)$</a> from the FDA in July 2025, the agency has requested the full clinical study report from the HOPE-3 Phase 3 trial as part of its review process. Capricor plans to submit the required updates to the BLA in February 2026 to support continued FDA evaluation, which may impact the timing of potential approval and market access for Deramiocel.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capricor <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9628399) on January 20, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>","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>FDA Requests Additional HOPE-3 Data for Capricor's Deramiocel Approval Review</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\">\nFDA Requests Additional HOPE-3 Data for Capricor's Deramiocel Approval Review\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2026-01-20 22:15</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Requests Additional HOPE-3 Data for Capricor's Deramiocel Approval Review\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/CAPR\">Capricor Therapeutics Inc</a>. is facing a regulatory issue related to its Biologics License Application (BLA) for Deramiocel, a cell therapy for Duchenne muscular dystrophy. Following a Complete Response Letter <a href=\"https://laohu8.com/S/CRL\">$(CRL)$</a> from the FDA in July 2025, the agency has requested the full clinical study report from the HOPE-3 Phase 3 trial as part of its review process. Capricor plans to submit the required updates to the BLA in February 2026 to support continued FDA evaluation, which may impact the timing of potential approval and market access for Deramiocel.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capricor <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9628399) on January 20, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00B3QW5Z07.USD","symbol_name":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260120:nNDL7ykRr:1","article_id":"2604465119","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2604465119","pubTimestamp":1768918544,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Capricor Therapeutics Inc. is facing a regulatory issue related to its Biologics License Application  for Deramiocel, a cell therapy for Duchenne muscular dystrophy. Following a Complete Response Letter  from the FDA in July 2025, the agency has requested the full clinical study report from the HOPE-3 Phase 3 trial as part of its review process. Capricor plans to submit the required updates to the BLA in February 2026 to support continued FDA evaluation, which may impact the timing of potential approval and market access for Deramiocel.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capricor Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire  on January 20, 2026, and is solely responsibl","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","BK4585":"ETF&股票定投概念","BK4588":"碎股","NDAQ":"纳斯达克OMX交易所","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","BK4112":"金融交易所和数据","SG9999014021.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","BK4139":"生物科技","SG9999014005.SGD":"United Global Durable Equities Fund Acc SGD","SG9999014039.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) INC","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","SG9999014013.SGD":"United Global Durable Equities Fund Dis SGD","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","CAPR":"Capricor Therapeutics Inc","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC"},"translate_title":"FDA要求为Capricor的Deramiocel审批审查提供额外的HOPE-3数据","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NDAQ":0.9,"CAPR":0.9},"content_text":"FDA Requests Additional HOPE-3 Data for Capricor's Deramiocel Approval Review\n    \n\nCapricor Therapeutics Inc. is facing a regulatory issue related to its Biologics License Application (BLA) for Deramiocel, a cell therapy for Duchenne muscular dystrophy. Following a Complete Response Letter $(CRL)$ from the FDA in July 2025, the agency has requested the full clinical study report from the HOPE-3 Phase 3 trial as part of its review process. Capricor plans to submit the required updates to the BLA in February 2026 to support continued FDA evaluation, which may impact the timing of potential approval and market access for Deramiocel.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capricor Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9628399) on January 20, 2026, and is solely responsible for the information contained therein.","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":false,"code":"91000000","status":"200"}}}