Clene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway

Reuters12-03

Clene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway

Clene Inc. announced the completion of FDA-recommended biomarker analyses for its investigational therapy CNM-Au8® in people living with amyotrophic lateral sclerosis (ALS). The results, which have already been completed, demonstrate statistically significant reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) in participants treated with CNM-Au8. These biomarker improvements are reported to be strongly associated with longer survival. Clene plans to present the full dataset to the FDA in a Type C meeting anticipated for the first quarter of 2026, as part of its strategy to submit a New Drug Application (NDA) under the accelerated approval pathway. The planned Phase 3 RESTORE-ALS trial will serve as the post-approval confirmatory study. The company is hosting an investor webcast to provide an update on the CNM-Au8 program.

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. Clene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9595857-en) on December 03, 2025, 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/2588046052?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-12-03 21:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2588046052","market":"us","top_or_hot":-1,"title":"Clene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway","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      Clene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway\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        <a href=\"https://laohu8.com/S/CLNN\">Clene Inc</a>. announced the completion of FDA-recommended biomarker analyses for its investigational therapy CNM-Au8® in people living with amyotrophic lateral sclerosis (ALS). The results, which have already been completed, demonstrate statistically significant reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) in participants treated with CNM-Au8. These biomarker improvements are reported to be strongly associated with longer survival. Clene plans to present the full dataset to the FDA in a Type C meeting anticipated for the first quarter of 2026, as part of its strategy to submit a New Drug Application (NDA) under the accelerated approval pathway. The planned Phase 3 <a href=\"https://laohu8.com/S/RST.UK\">RESTORE</a>-ALS trial will serve as the post-approval confirmatory study. The company is hosting an investor webcast to provide an update on the CNM-Au8 program.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>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. Clene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9595857-en) on December 03, 2025, and is solely responsible for the information contained therein.</span></em>\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>Clene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway</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\">\nClene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway\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\">2025-12-03 21:00</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      Clene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway\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        <a href=\"https://laohu8.com/S/CLNN\">Clene Inc</a>. announced the completion of FDA-recommended biomarker analyses for its investigational therapy CNM-Au8® in people living with amyotrophic lateral sclerosis (ALS). The results, which have already been completed, demonstrate statistically significant reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) in participants treated with CNM-Au8. These biomarker improvements are reported to be strongly associated with longer survival. Clene plans to present the full dataset to the FDA in a Type C meeting anticipated for the first quarter of 2026, as part of its strategy to submit a New Drug Application (NDA) under the accelerated approval pathway. The planned Phase 3 <a href=\"https://laohu8.com/S/RST.UK\">RESTORE</a>-ALS trial will serve as the post-approval confirmatory study. The company is hosting an investor webcast to provide an update on the CNM-Au8 program.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>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. Clene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9595857-en) on December 03, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2210150020.SGD","symbol_name":"Natixis Thematics Subscription Economy R/A SGD","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251203:nNDL8d29g7:1","article_id":"2588046052","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2588046052","pubTimestamp":1764766819,"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":"Clene Inc. announced the completion of FDA-recommended biomarker analyses for its investigational therapy CNM-Au8 in people living with amyotrophic lateral sclerosis . The results, which have already been completed, demonstrate statistically significant reductions in neurofilament light  and glial fibrillary acidic protein  in participants treated with CNM-Au8. These biomarker improvements are reported to be strongly associated with longer survival. Clene plans to present the full dataset to the FDA in a Type C meeting anticipated for the first quarter of 2026, as part of its strategy to submit a New Drug Application  under the accelerated approval pathway. The planned Phase 3 RESTORE-ALS trial will serve as the post-approval confirmatory study. The company is hosting an investor webcast to provide an update on the CNM-Au8 program.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely i","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","BK4139":"生物科技","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","NDAQ":"纳斯达克OMX交易所","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","BK4585":"ETF&股票定投概念","CLNN":"Clene Inc","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","BK4588":"碎股","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","BK4112":"金融交易所和数据","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC"},"translate_title":"Clene报告CNM-Au8具有统计学意义的ALS生物标志物结果，支持FDA加速批准途径","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CLNN":0.9,"NDAQ":0.9},"content_text":"Clene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway\n    \n\nClene Inc. announced the completion of FDA-recommended biomarker analyses for its investigational therapy CNM-Au8® in people living with amyotrophic lateral sclerosis (ALS). The results, which have already been completed, demonstrate statistically significant reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) in participants treated with CNM-Au8. These biomarker improvements are reported to be strongly associated with longer survival. Clene plans to present the full dataset to the FDA in a Type C meeting anticipated for the first quarter of 2026, as part of its strategy to submit a New Drug Application (NDA) under the accelerated approval pathway. The planned Phase 3 RESTORE-ALS trial will serve as the post-approval confirmatory study. The company is hosting an investor webcast to provide an update on the CNM-Au8 program.\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. Clene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9595857-en) on December 03, 2025, 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":"policyRegulatory,dataReport,express","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,"deviceId":"web-server-community-laohu8-v3","version":"4.35.12","shortVersion":"4.35.12","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/2588046052","isCrawlerRequest":true}