Sarepta股价下跌，因Elevidys未获欧盟监管机构支持

英为财情

2025/07/25

Investing.com - Sarepta Therapeutics Inc. (NASDAQ:SRPT)股价周五下跌13%，此前欧洲监管机构建议不批准该公司用于治疗杜氏肌营养不良症的基因疗法Elevidys。欧洲药品管理局的药物咨询委员会(CHMP)周五宣布，拒绝批准Elevidys用于治疗3至7岁能够行走的儿童。这种疗法在美国以外由罗氏控股(Roche Holding AG) (...

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(NASDAQ:SRPT)股价周五下跌13%，此前欧洲监管机构建议不批准该公司用于治疗杜氏肌营养不良症的基因疗法Elevidys。\n欧洲药品管理局的药物咨询委员会(CHMP)周五宣布，拒绝批准Elevidys用于治疗3至7岁能够行走的儿童。这种疗法在美国以外由罗氏控股(Roche Holding AG) (...</p>\n\n<a href=\"https://cn.investing.com/news/stock-market-news/article-2903281\">网页链接</a>\n\n</div>\n","source":"investing_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>Sarepta股价下跌，因Elevidys未获欧盟监管机构支持</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\">\nSarepta股价下跌，因Elevidys未获欧盟监管机构支持\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-07-25 19:08 北京时间&nbsp;&nbsp;&nbsp;<a href=https://cn.investing.com/news/stock-market-news/article-2903281><strong>英为财情</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Investing.com -  Sarepta  Therapeutics Inc. (NASDAQ:SRPT)股价周五下跌13%，此前欧洲监管机构建议不批准该公司用于治疗杜氏肌营养不良症的基因疗法Elevidys。\n欧洲药品管理局的药物咨询委员会(CHMP)周五宣布，拒绝批准Elevidys用于治疗3至7岁能够行走的儿童。这种疗法在美国以外由罗氏控股(Roche Holding AG) (...</p>\n\n<a href=\"https://cn.investing.com/news/stock-market-news/article-2903281\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE0002141913.USD","symbol_name":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","start_time":0,"source_url":"https://cn.investing.com/news/stock-market-news/article-2903281","article_id":"2554616117","we_media_id":null,"thumbnails":[],"rights":{"source":"investing_news","url":"https://cn.investing.com/news/stock-market-news/article-2903281","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2554616117","pubTimestamp":1753441680,"columns":[],"sourceInfo":{"source_id":"investing_news","name":"英为财情新闻"},"weMediaInfo":null,"summary":"Investing.com -  Sarepta  Therapeutics Inc. 股价周五下跌13%，此前欧洲监管机构建议不批准该公司用于治疗杜氏肌营养不良症的基因疗法Elevidys。欧洲药品管理局的药物咨询委员会周五宣布，拒绝批准Elevidys用于治疗3至7岁能够行走的儿童。这一挫折紧随美国食品药品监督管理局最近要求暂停在美国使用Elevidys之后。Sarepta本周早些时候已宣布暂时停止在美国的出货。在美国和欧洲市场的双重监管挫折，对Sarepta的Elevidys商业化战略构成了重大挑战，该产品此前被定位为这种衰弱性疾病的突破性治疗选择。","collect":0,"end_time":0,"defaultTopTitle":"investing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","SRPT":"Sarepta Therapeutics","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","BK4585":"ETF&股票定投概念","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","BK4087":"商业印刷","BK4139":"生物科技","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","CHMP":"冠军工业"},"translate_title":"Sarepta shares fall as Elevidys doesn't get support from EU regulators","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SRPT":1,"CHMP":1},"content_text":"Investing.com -  Sarepta  Therapeutics Inc. (NASDAQ:SRPT)股价周五下跌13%，此前欧洲监管机构建议不批准该公司用于治疗杜氏肌营养不良症的基因疗法Elevidys。\n欧洲药品管理局的药物咨询委员会(CHMP)周五宣布，拒绝批准Elevidys用于治疗3至7岁能够行走的儿童。这种疗法在美国以外由罗氏控股(Roche Holding AG) (SIX:ROG)负责销售，此前正寻求获批用于治疗这种导致肌肉进行性衰弱的罕见遗传性疾病。\n这一挫折紧随美国食品药品监督管理局(FDA)最近要求暂停在美国使用Elevidys之后。Sarepta本周早些时候已宣布暂时停止在美国的出货。\n罗氏也已在参考FDA批准的司法管辖区暂停出货，进一步限制了该疗法的市场覆盖范围。这家瑞士制药巨头在与Sarepta合作后，负责在美国以外市场商业化这一治疗方案。\n杜氏肌营养不良症是一种罕见的遗传性疾病，主要影响男孩，导致肌肉进行性退化。这种疾病最终是致命的，患者通常会经历严重的行动障碍，寿命也会缩短。\n在美国和欧洲市场的双重监管挫折，对Sarepta的Elevidys商业化战略构成了重大挑战，该产品此前被定位为这种衰弱性疾病的突破性治疗选择。\n本文由人工智能协助翻译。更多信息，请参见我们的使用条款。","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"}}}