Rezolute Gets US FDA Breakthrough Therapy Designation for Hypoglycemia Treatment

MT Newswires Live

May 05, 2025

Rezolute (RZLT) said the US Food and Drug Administration granted breakthrough therapy designation for its investigational treatment for ersodetug, a treatment for hypoglycemia caused by tumor hyperinsulinism.

The designation was awarded based on clinical trial data across an overall development program that showed the treatment works in a way that directly targets the underlying cause of the tumor hyperinsulinism, the company said Monday in a statement.

Rezolute plans to start a registrational study of the drug in patients with tumor hyperinsulinism in the middle of this year with topline results expected in H2 2026.

The company is also evaluating ersodetug for the treatment of hypoglycemia caused by congenital hyperinsulinism in a Phase 3 trial.

Price: 4.01, Change: +0.01, Percent Change: +0.25

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/2533533713"},"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:\"2533533713\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2533533713?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-05-05 22:34","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2533533713","market":"nz","top_or_hot":-1,"title":"Rezolute Gets US FDA Breakthrough Therapy Designation for Hypoglycemia Treatment","media":"MT Newswires Live","content":"<html><body><p> Rezolute (RZLT) said the US Food and Drug Administration granted breakthrough therapy designation for its investigational treatment for ersodetug, a treatment for hypoglycemia caused by tumor hyperinsulinism.</p><p>The designation was awarded based on clinical trial data across an overall development program that showed the treatment works in a way that directly targets the underlying cause of the tumor hyperinsulinism, the company said Monday in a statement.</p><p>Rezolute plans to start a registrational study of the drug in patients with tumor hyperinsulinism in the middle of this year with topline results expected in H2 2026.</p><p>The company is also evaluating ersodetug for the treatment of hypoglycemia caused by congenital hyperinsulinism in a Phase 3 trial.</p><p>Price: 4.01, Change: +0.01, Percent Change: +0.25</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>Rezolute Gets US FDA Breakthrough Therapy Designation for Hypoglycemia Treatment</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\">\nRezolute Gets US FDA Breakthrough Therapy Designation for Hypoglycemia Treatment\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\">2025-05-05 22:34</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Rezolute (RZLT) said the US Food and Drug Administration granted breakthrough therapy designation for its investigational treatment for ersodetug, a treatment for hypoglycemia caused by tumor hyperinsulinism.</p><p>The designation was awarded based on clinical trial data across an overall development program that showed the treatment works in a way that directly targets the underlying cause of the tumor hyperinsulinism, the company said Monday in a statement.</p><p>Rezolute plans to start a registrational study of the drug in patients with tumor hyperinsulinism in the middle of this year with topline results expected in H2 2026.</p><p>The company is also evaluating ersodetug for the treatment of hypoglycemia caused by congenital hyperinsulinism in a Phase 3 trial.</p><p>Price: 4.01, Change: +0.01, Percent Change: +0.25</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":"2533533713","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2533533713","pubTimestamp":1746455669,"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":"Rezolute (RZLT) said the US Food and Drug Administration granted breakthrough therapy designation for its investigational treatment for ersodetug, a treatment for hypoglycemia caused by tumor hyperins","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","RZLT":"Rezolute, Inc."},"translate_title":"Rezolute获美国FDA突破性疗法认定，用于低血糖治疗","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"RZLT":0.9},"content_text":"Rezolute (RZLT) said the US Food and Drug Administration granted breakthrough therapy designation for its investigational treatment for ersodetug, a treatment for hypoglycemia caused by tumor hyperinsulinism.The designation was awarded based on clinical trial data across an overall development program that showed the treatment works in a way that directly targets the underlying cause of the tumor hyperinsulinism, the company said Monday in a statement.Rezolute plans to start a registrational study of the drug in patients with tumor hyperinsulinism in the middle of this year with topline results expected in H2 2026.The company is also evaluating ersodetug for the treatment of hypoglycemia caused by congenital hyperinsulinism in a Phase 3 trial.Price: 4.01, Change: +0.01, Percent Change: +0.25","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"}}}