InflaRx Says Severe Covid Drug Gets EU Panel's Positive Opinion; Shares Rise Pre-Bell

MT Newswires Live11-15

InflaRx (IFRX) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization under exceptional circumstances for Gohibic, or vilobelimab, to treat adults with Covid-induced acute respiratory distress syndrome.

The proposed indication for the drug is for patients already receiving systemic corticosteroids and invasive mechanical ventilation, the company said.

The company said it expects the European Commission to adopt the committee's positive opinion and issue a marketing authorization for the indication within 67 days.

The positive opinion follows results of a phase 3 trial which showed a 23.9% reduction in mortality compared to placebo over 28 days.

The company's shares were up more than 10% in recent Friday premarket activity.

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.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2483379660?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-11-15 21:42","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2483379660","market":"sg","top_or_hot":-1,"title":"InflaRx Says Severe Covid Drug Gets EU Panel's Positive Opinion; Shares Rise Pre-Bell","media":"MT Newswires Live","content":"<html><body><p> InflaRx (IFRX) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization under exceptional circumstances for Gohibic, or vilobelimab, to treat adults with Covid-induced acute respiratory distress syndrome.</p><p>The proposed indication for the drug is for patients already receiving systemic corticosteroids and invasive mechanical ventilation, the company said.</p><p>The company said it expects the European Commission to adopt the committee's positive opinion and issue a marketing authorization for the indication within 67 days.</p><p>The positive opinion follows results of a phase 3 trial which showed a 23.9% reduction in mortality compared to placebo over 28 days.</p><p>The company's shares were up more than 10% in recent Friday premarket activity.</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>InflaRx Says Severe Covid Drug Gets EU Panel's Positive Opinion; Shares Rise Pre-Bell</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\">\nInflaRx Says Severe Covid Drug Gets EU Panel's Positive Opinion; Shares Rise Pre-Bell\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-15 21:42 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.mtnewswires.com/><strong>MT Newswires Live</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>InflaRx (IFRX) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization under exceptional circumstances for Gohibic, or ...</p>\n\n<a href=\"https://www.mtnewswires.com/\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4156","symbol_name":"煤与消费用燃料","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2483379660","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2483379660","pubTimestamp":1731678157,"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":"InflaRx  said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization under exceptional circumstances for Gohibic, or vilobelimab, to treat adults with Covid-induced acute respiratory distress syndrome.The proposed indication for the drug is for patients already receiving systemic corticosteroids and invasive mechanical ventilation, the company said.The company said it expects the European Commission to adopt the committee's positive opinion and issue a marketing authorization for the indication within 67 days.The positive opinion follows results of a phase 3 trial which showed a 23.9% reduction in mortality compared to placebo over 28 days.The company's shares were up more than 10% in recent Friday premarket activity.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4156":"煤与消费用燃料","BK4139":"生物科技","IFRX":"InflaRx N.V."},"translate_title":"InflaRx表示严重的Covid药物获得欧盟小组的积极意见；盘前股价上涨","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IFRX":0.9},"content_text":"InflaRx (IFRX) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization under exceptional circumstances for Gohibic, or vilobelimab, to treat adults with Covid-induced acute respiratory distress syndrome.The proposed indication for the drug is for patients already receiving systemic corticosteroids and invasive mechanical ventilation, the company said.The company said it expects the European Commission to adopt the committee's positive opinion and issue a marketing authorization for the indication within 67 days.The positive opinion follows results of a phase 3 trial which showed a 23.9% reduction in mortality compared to placebo over 28 days.The company's shares were up more than 10% in recent Friday premarket activity.","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":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2483379660"}