Rezolute reports FDA meeting outcomes for its Phase 3 sunRIZE trial of ersodetug in congenital hyperinsulinism

Reuters03-24 19:02

Rezolute reports FDA meeting outcomes for its Phase 3 sunRIZE trial of ersodetug in congenital hyperinsulinism

Rezolute reported outcomes from an in-person FDA Type B meeting about sunRIZE, a Phase 3 multicenter, double-blind, randomized, placebo-controlled trial of ersodetug for congenital hyperinsulinism.
SunRIZE previously showed reductions from baseline in hypoglycemia events, but did not meet its primary endpoint because reductions were not statistically significant versus placebo.
CGM results showed consistent improvements versus placebo over the full pivotal treatment period, while nominal statistical significance was not achieved for time in hypoglycemia at Week 24.
Rezolute plans to present pivotal sunRIZE outcomes at an upcoming scientific conference, and FDA encouraged submission of study reports and analysis datasets for independent review.
The company said it expects to provide a program update in the second half of 2026.

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. Rezolute Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603240700PRIMZONEFULLFEED9677350) on March 24, 2026, and is solely responsible for the information contained therein.

At the request of the copyright holder, you need to log in to view this content

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/2621662280?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-03-24 19:02","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2621662280","market":"us","top_or_hot":-1,"title":"Rezolute reports FDA meeting outcomes for its Phase 3 sunRIZE trial of ersodetug in congenital hyperinsulinism","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      Rezolute reports FDA meeting outcomes for its Phase 3 sunRIZE trial of ersodetug in congenital hyperinsulinism\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<ul>\n<li>\n          Rezolute reported outcomes from an in-person FDA Type B meeting about sunRIZE, a Phase 3 multicenter, double-blind, randomized, placebo-controlled trial of ersodetug for congenital hyperinsulinism.\n        </li>\n<li>\n          SunRIZE previously showed reductions from baseline in hypoglycemia events, but did not meet its primary endpoint because reductions were not statistically significant versus placebo.\n        </li>\n<li>\n          CGM results showed consistent improvements versus placebo over the full pivotal treatment period, while nominal statistical significance was not achieved for time in hypoglycemia at Week 24.\n        </li>\n<li>\n          Rezolute plans to present pivotal sunRIZE outcomes at an upcoming scientific conference, and FDA encouraged submission of study reports and analysis datasets for independent review.\n        </li>\n<li>\n          The company said it expects to provide a program update in the second half of 2026.\n        </li>\n</ul>\n<br/>\n<br/>\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. Rezolute Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603240700PRIMZONEFULLFEED9677350) on March 24, 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>Rezolute reports FDA meeting outcomes for its Phase 3 sunRIZE trial of ersodetug in congenital hyperinsulinism</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 reports FDA meeting outcomes for its Phase 3 sunRIZE trial of ersodetug in congenital hyperinsulinism\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\">2026-03-24 19:02</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      Rezolute reports FDA meeting outcomes for its Phase 3 sunRIZE trial of ersodetug in congenital hyperinsulinism\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<ul>\n<li>\n          Rezolute reported outcomes from an in-person FDA Type B meeting about sunRIZE, a Phase 3 multicenter, double-blind, randomized, placebo-controlled trial of ersodetug for congenital hyperinsulinism.\n        </li>\n<li>\n          SunRIZE previously showed reductions from baseline in hypoglycemia events, but did not meet its primary endpoint because reductions were not statistically significant versus placebo.\n        </li>\n<li>\n          CGM results showed consistent improvements versus placebo over the full pivotal treatment period, while nominal statistical significance was not achieved for time in hypoglycemia at Week 24.\n        </li>\n<li>\n          Rezolute plans to present pivotal sunRIZE outcomes at an upcoming scientific conference, and FDA encouraged submission of study reports and analysis datasets for independent review.\n        </li>\n<li>\n          The company said it expects to provide a program update in the second half of 2026.\n        </li>\n</ul>\n<br/>\n<br/>\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. Rezolute Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603240700PRIMZONEFULLFEED9677350) on March 24, 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":"IE00BGHQF748.EUR","symbol_name":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260324:nNDL42s7hy:1","article_id":"2621662280","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2621662280","pubTimestamp":1774350155,"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":"Rezolute reported outcomes from an in-person FDA Type B meeting about sunRIZE, a Phase 3 multicenter, double-blind, randomized, placebo-controlled trial of ersodetug for congenital hyperinsulinism.SunRIZE previously showed reductions from baseline in hypoglycemia events, but did not meet its primary endpoint because reductions were not statistically significant versus placebo.CGM results showed consistent improvements versus placebo over the full pivotal treatment period, while nominal statistical significance was not achieved for time in hypoglycemia at Week 24.Rezolute plans to present pivotal sunRIZE outcomes at an upcoming scientific conference, and FDA encouraged submission of study reports and analysis datasets for independent review.The company said it expects to provide a program update in the second half of 2026.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","IE00BN0W2W23.USD":"GUINNESS SUSTAINABLE GLOBAL EQUITY \"C\" (USD) ACC","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","IE00BN0W2V16.EUR":"GUINNESS SUSTAINABLE GLOBAL EQUITY \"C\" (EUR) ACC","BK4585":"ETF&股票定投概念","BK4139":"生物科技","IE00BN0W2T93.GBP":"GUINNESS SUSTAINABLE GLOBAL EQUITY \"C\" (GBP) ACC","RZLT":"Rezolute, Inc.","NDAQ":"纳斯达克OMX交易所","BK4588":"碎股","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","SG9999014039.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) INC","BK4112":"金融交易所和数据","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","SG9999014021.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","SG9999014005.SGD":"United Global Durable Equities Fund Acc SGD","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","SG9999014013.SGD":"United Global Durable Equities Fund Dis SGD","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H"},"translate_title":"Rezolute报告其ersodetug治疗先天性高胰岛素血症的3期sunRIZE试验的FDA会议结果","themeId":"ab6e84fb0542480d9cf75cb6a9fe5601","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"RZLT":0.9,"NDAQ":0.9},"content_text":"Rezolute reports FDA meeting outcomes for its Phase 3 sunRIZE trial of ersodetug in congenital hyperinsulinism\n    \n\n\n          Rezolute reported outcomes from an in-person FDA Type B meeting about sunRIZE, a Phase 3 multicenter, double-blind, randomized, placebo-controlled trial of ersodetug for congenital hyperinsulinism.\n        \n\n          SunRIZE previously showed reductions from baseline in hypoglycemia events, but did not meet its primary endpoint because reductions were not statistically significant versus placebo.\n        \n\n          CGM results showed consistent improvements versus placebo over the full pivotal treatment period, while nominal statistical significance was not achieved for time in hypoglycemia at Week 24.\n        \n\n          Rezolute plans to present pivotal sunRIZE outcomes at an upcoming scientific conference, and FDA encouraged submission of study reports and analysis datasets for independent review.\n        \n\n          The company said it expects to provide a program update in the second half of 2026.\n        \n\n\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. Rezolute Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603240700PRIMZONEFULLFEED9677350) on March 24, 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":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"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,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.38.0","shortVersion":"4.38.0","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/2621662280","isCrawlerRequest":true}