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

Reuters

Dec 03, 2025

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.

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

LOGIN / SIGN UP

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

1
2
3
4
5
6
7
8
9
10

{"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-web.itiger.com/news/2588046052"},"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:\"2588046052\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"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":"nz","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":"BK4588","symbol_name":"碎股","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":{"BK4588":"碎股","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","BK4112":"金融交易所和数据","NDAQ":"纳斯达克OMX交易所","BK4585":"ETF&股票定投概念","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","BK4139":"生物科技","CLNN":"Clene Inc","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","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":{"NDAQ":0.9,"CLNN":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":true,"code":"91000000","status":"200"}}}