GSK, Spero Therapeutics Get FDA Approval for Utebzi in Complicated Urinary Tract Infections

MT Newswires Live06-18

GSK (GSK) and Spero Therapeutics (SPRO) said Wednesday that the US Food and Drug Administration has approved Utebzi as treatment for complicated urinary tract infections, including pyelonephritis, in adults.

Utebzi, or tebipenem pivoxil, is the first and only oral carbapenem antibiotic approved in the US and is expected to become available by the end of 2026, the companies said.

The approval was based on phase 3 trial data showing Utebzi's non-inferiority to intravenous imipenem-cilastatin, with tebipenem pivoxil achieving an overall success rate of 58.5% against 60.2% for imipenem-cilastatin, according to a statement. Tebipenem pivoxil's safety profile is also "generally similar" to that of imipenem-cilastatin, the companies said.

GSK shares were up about 1%, while Spero stock was down more than 14% in Wednesday trading.

Price: 52.72, Change: +0.50, Percent Change: +0.96

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/2644740373?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-06-18 00:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2644740373","market":"us","top_or_hot":-1,"title":"GSK, Spero Therapeutics Get FDA Approval for Utebzi in Complicated Urinary Tract Infections","media":"MT Newswires Live","content":"<html><body><p> GSK (GSK) and Spero <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (SPRO) said Wednesday that the US Food and Drug Administration has approved Utebzi as treatment for complicated urinary tract infections, including pyelonephritis, in adults.</p><p>Utebzi, or tebipenem pivoxil, is the first and only oral carbapenem antibiotic approved in the US and is expected to become available by the end of 2026, the companies said.</p><p>The approval was based on phase 3 trial data showing Utebzi's non-inferiority to intravenous imipenem-cilastatin, with tebipenem pivoxil achieving an overall success rate of 58.5% against 60.2% for imipenem-cilastatin, according to a statement. Tebipenem pivoxil's safety profile is also \"generally similar\" to that of imipenem-cilastatin, the companies said.</p><p>GSK shares were up about 1%, while Spero stock was down more than 14% in Wednesday trading.</p><p>Price: 52.72, Change: +0.50, Percent Change: +0.96</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>GSK, Spero Therapeutics Get FDA Approval for Utebzi in Complicated Urinary Tract Infections</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\">\nGSK, Spero Therapeutics Get FDA Approval for Utebzi in Complicated Urinary Tract Infections\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\">2026-06-18 00:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> GSK (GSK) and Spero <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (SPRO) said Wednesday that the US Food and Drug Administration has approved Utebzi as treatment for complicated urinary tract infections, including pyelonephritis, in adults.</p><p>Utebzi, or tebipenem pivoxil, is the first and only oral carbapenem antibiotic approved in the US and is expected to become available by the end of 2026, the companies said.</p><p>The approval was based on phase 3 trial data showing Utebzi's non-inferiority to intravenous imipenem-cilastatin, with tebipenem pivoxil achieving an overall success rate of 58.5% against 60.2% for imipenem-cilastatin, according to a statement. Tebipenem pivoxil's safety profile is also \"generally similar\" to that of imipenem-cilastatin, the companies said.</p><p>GSK shares were up about 1%, while Spero stock was down more than 14% in Wednesday trading.</p><p>Price: 52.72, Change: +0.50, Percent Change: +0.96</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SPRO","symbol_name":"Spero Therapeutics Inc.","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2644740373","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2644740373","pubTimestamp":1781712056,"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":"GSK  and Spero Therapeutics  said Wednesday that the US Food and Drug Administration has approved Utebzi as treatment for complicated urinary tract infections, including pyelonephritis, in adults.Utebzi, or tebipenem pivoxil, is the first and only oral carbapenem antibiotic approved in the US and is expected to become available by the end of 2026, the companies said.The approval was based on phase 3 trial data showing Utebzi's non-inferiority to intravenous imipenem-cilastatin, with tebipenem pivoxil achieving an overall success rate of 58.5% against 60.2% for imipenem-cilastatin, according to a statement. Tebipenem pivoxil's safety profile is also \"generally similar\" to that of imipenem-cilastatin, the companies said.GSK shares were up about 1%, while Spero stock was down more than 14% in Wednesday trading.Price: 52.72, Change: +0.50, Percent Change: +0.96","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"SPRO":"Spero Therapeutics Inc.","LENZ":"Therapeutics","BK4588":"碎股","BK4539":"次新股","BK4585":"ETF&股票定投概念","GSKH":"GSK plc ADRhedged","GSK":"葛兰素史克","LABU":"三倍做多标普生物-Direxion","GSK.UK":"葛兰素史克","BK4139":"生物科技","BK4532":"文艺复兴科技持仓","LU1829250122.USD":"高盛欧洲核心股票组合Acc","BK4007":"制药"},"translate_title":"GSK和Spero Therapeutics获得FDA批准Utebzi治疗复杂尿路感染","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SPRO":1,"GSK":1.5,"LABU":1.5,"LENZ":1.5,"GSKH":0.6,"GSK.UK":0.6},"content_text":"GSK (GSK) and Spero Therapeutics (SPRO) said Wednesday that the US Food and Drug Administration has approved Utebzi as treatment for complicated urinary tract infections, including pyelonephritis, in adults.Utebzi, or tebipenem pivoxil, is the first and only oral carbapenem antibiotic approved in the US and is expected to become available by the end of 2026, the companies said.The approval was based on phase 3 trial data showing Utebzi's non-inferiority to intravenous imipenem-cilastatin, with tebipenem pivoxil achieving an overall success rate of 58.5% against 60.2% for imipenem-cilastatin, according to a statement. Tebipenem pivoxil's safety profile is also \"generally similar\" to that of imipenem-cilastatin, the companies said.GSK shares were up about 1%, while Spero stock was down more than 14% in Wednesday trading.Price: 52.72, Change: +0.50, Percent Change: +0.96","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"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,"isLaohu8Offline":false,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.44.0","shortVersion":"4.44.0","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/2644740373","isCrawlerRequest":true}