Altimmune Earns FDA Breakthrough Therapy Designation for Pemvidutide in MASH

Reuters01-05

Altimmune Earns FDA Breakthrough Therapy Designation for Pemvidutide in MASH

Altimmune Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The designation was based on 24-week data from the IMPACT Phase 2b trial, which demonstrated statistically significant MASH resolution without worsening of fibrosis, as well as early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation. In December 2025, Altimmune reported 48-week topline data showing continued statistically significant improvements versus placebo in key non-invasive tests, further weight loss, and a favorable tolerability profile. The company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period, incorporating biopsy-based endpoints and the use of AIM-MASH AI Assist, an FDA-qualified AI pathology tool.

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. Altimmune Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9619588) on January 05, 2026, and is solely responsible for the information contained therein.

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/2601898348?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-01-05 20:31","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2601898348","market":"nz","top_or_hot":-1,"title":"Altimmune Earns FDA Breakthrough Therapy Designation for Pemvidutide in MASH","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      Altimmune Earns FDA Breakthrough Therapy Designation for Pemvidutide in MASH\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Altimmune Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The designation was based on 24-week data from the IMPACT Phase 2b trial, which demonstrated statistically significant MASH resolution without worsening of fibrosis, as well as early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation. In December 2025, Altimmune reported 48-week topline data showing continued statistically significant improvements versus placebo in key non-invasive tests, further weight loss, and a favorable tolerability profile. The company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period, incorporating biopsy-based endpoints and the use of AIM-MASH AI Assist, an FDA-qualified AI pathology tool.\n      </p>\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. Altimmune Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9619588) on January 05, 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>Altimmune Earns FDA Breakthrough Therapy Designation for Pemvidutide in MASH</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\">\nAltimmune Earns FDA Breakthrough Therapy Designation for Pemvidutide in MASH\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\">2026-01-05 20:31</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      Altimmune Earns FDA Breakthrough Therapy Designation for Pemvidutide in MASH\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Altimmune Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The designation was based on 24-week data from the IMPACT Phase 2b trial, which demonstrated statistically significant MASH resolution without worsening of fibrosis, as well as early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation. In December 2025, Altimmune reported 48-week topline data showing continued statistically significant improvements versus placebo in key non-invasive tests, further weight loss, and a favorable tolerability profile. The company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period, incorporating biopsy-based endpoints and the use of AIM-MASH AI Assist, an FDA-qualified AI pathology tool.\n      </p>\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. Altimmune Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9619588) on January 05, 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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260105:nNDL2CVwZQ:1","article_id":"2601898348","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2601898348","pubTimestamp":1767616267,"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":"Altimmune Inc. has announced that the U.S. Food and Drug Administration  has granted Breakthrough Therapy Designation for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis . The designation was based on 24-week data from the IMPACT Phase 2b trial, which demonstrated statistically significant MASH resolution without worsening of fibrosis, as well as early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation. In December 2025, Altimmune reported 48-week topline data showing continued statistically significant improvements versus placebo in key non-invasive tests, further weight loss, and a favorable tolerability profile. The company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period, incorporating biopsy-based endpoints and the use of AIM-MASH AI Assist, an FDA-qualified AI pathology tool.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","SG9999014039.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) INC","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","SG9999014021.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","SG9999014013.SGD":"United Global Durable Equities Fund Dis SGD","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","BK4112":"金融交易所和数据","BK4588":"碎股","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","ALT":"Altimmune, Inc.","LU1878469433.USD":"THREADNEEDLE (LUX) - AMERICAN SMALLER COMPANIES \"A\" (USD) ACC","SG9999014005.SGD":"United Global Durable Equities Fund Acc SGD","BK4599":"减肥药","BK4585":"ETF&股票定投概念","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","NDAQ":"纳斯达克OMX交易所"},"translate_title":"Altimmune在MASH中的Pemvidutide获得FDA突破性疗法认定","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NDAQ":0.9,"ALT":0.9},"content_text":"Altimmune Earns FDA Breakthrough Therapy Designation for Pemvidutide in MASH\n    \n\n        Altimmune Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The designation was based on 24-week data from the IMPACT Phase 2b trial, which demonstrated statistically significant MASH resolution without worsening of fibrosis, as well as early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation. In December 2025, Altimmune reported 48-week topline data showing continued statistically significant improvements versus placebo in key non-invasive tests, further weight loss, and a favorable tolerability profile. The company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period, incorporating biopsy-based endpoints and the use of AIM-MASH AI Assist, an FDA-qualified AI pathology tool.\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. Altimmune Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9619588) on January 05, 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":"2","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":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,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.0","shortVersion":"4.36.0","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/2601898348","isCrawlerRequest":true}