Amylyx Halts Rare Brain Disorder Drug Program After Disappointing Trial

Benzinga

2025/08/28

Amylyx Pharmaceuticals, Inc. AMLX on Wednesday decided to discontinue the ORION program of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults ...

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AMLX on Wednesday decided to discontinue the ORION program of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults ...</p>\n\n<a href=\"https://www.benzinga.com/news/health-care/25/08/47364006/amylyx-halts-rare-brain-disorder-drug-program-after-disappointing-trial\">网页链接</a>\n\n</div>\n","source":"benzinga_hot_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>Amylyx Halts Rare Brain Disorder Drug Program After Disappointing Trial</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\">\nAmylyx Halts Rare Brain Disorder Drug Program After Disappointing Trial\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-08-28 00:25 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/health-care/25/08/47364006/amylyx-halts-rare-brain-disorder-drug-program-after-disappointing-trial><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Amylyx Pharmaceuticals, Inc. AMLX on Wednesday decided to discontinue the ORION program of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults ...</p>\n\n<a href=\"https://www.benzinga.com/news/health-care/25/08/47364006/amylyx-halts-rare-brain-disorder-drug-program-after-disappointing-trial\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"PSP","symbol_name":"全球私募股权ETFETF-PowerShares","start_time":0,"source_url":"https://www.benzinga.com/news/health-care/25/08/47364006/amylyx-halts-rare-brain-disorder-drug-program-after-disappointing-trial","article_id":"2562726538","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2025/08/27/Genetic-Research-And-Biotech-Science-Con.jpeg?optimize=medium&dpr=2&auto=webp&width=630"],"rights":{"source":"benzinga_hot_news","url":"https://www.benzinga.com/news/health-care/25/08/47364006/amylyx-halts-rare-brain-disorder-drug-program-after-disappointing-trial","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2562726538","pubTimestamp":1756311900,"columns":[],"sourceInfo":{"source_id":"benzinga_hot_news","name":"Benzinga"},"weMediaInfo":null,"summary":"Amylyx Pharmaceuticals, Inc. AMLX on Wednesday decided to discontinue the ORION program of AMX0035  in adults living with progressive supranuclear palsy .PSP is a rare, degenerative brain disorder causing issues with balance, movement, eye movements, speech, swallowing, mood, and cognition.AMX0035 did not show differences compared to placebo on primary or secondary outcomes at Week 24.Also Read: Amylyx Eyes $2B Opportunity In Post-Surgery Sugar Crash Market. Amylyx says its highest priority and focus remain on the pivotal Phase 3 LUCIDITY trial of avexitide, with enrollment expected to be completed in 2025 and topline data anticipated in the first half of 2026.In July, Amylyx Pharmaceuticals presented new exploratory analyses from its Phase 2 PREVENT and Phase 2b trials of avexitide, an investigational GLP-1 receptor antagonist, at the Endocrine Society’s annual meeting.In the Phase 2b trial, a 90 mg once-daily dose of avexitide, now being evaluated in the Phase 3 LUCIDITY trial, achie","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"PSP":"全球私募股权ETFETF-PowerShares"},"translate_title":"Amylyx在令人失望的试验后停止罕见脑部疾病药物项目","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PSP":1},"content_text":"Amylyx Pharmaceuticals, Inc. AMLX on Wednesday decided to discontinue the ORION program of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults living with progressive supranuclear palsy (PSP).\nPSP is a rare, degenerative brain disorder causing issues with balance, movement, eye movements, speech, swallowing, mood, and cognition.\nAMX0035 did not show differences compared to placebo on primary or secondary outcomes at Week 24.\nAlso Read: Amylyx Eyes $2B Opportunity In Post-Surgery Sugar Crash Market\nBased on these results, the company will discontinue the Phase 2b trial and open-label extension and will not initiate the Phase 3 portion of the program.\nSafety data were consistent with safety data from prior studies, and AMX0035 continued to be generally well-tolerated.\nAmylyx says its highest priority and focus remain on the pivotal Phase 3 LUCIDITY trial of avexitide, with enrollment expected to be completed in 2025 and topline data anticipated in the first half of 2026.\nThe company is also continuing development of AMX0035 in Wolfram syndrome and progressing AMX0114 in amyotrophic lateral sclerosis (ALS), with early cohort data from the Phase 1 LUMINA trial expected in 2025.\nIn July, Amylyx Pharmaceuticals presented new exploratory analyses from its Phase 2 PREVENT and Phase 2b trials of avexitide, an investigational GLP-1 receptor antagonist, at the Endocrine Society’s annual meeting.\nIn the Phase 2b trial, a 90 mg once-daily dose of avexitide, now being evaluated in the Phase 3 LUCIDITY trial, achieved a 64% reduction in the rate of moderate to severe hypoglycemic events. More than half of the participants experienced no such events during treatment.\nAmylyx expects its cash runway to extend through the end of 2026.\nIn March 2024, Amylyx shared topline results from the PHOENIX Phase 3 trial of AMX0035, also known as Relyvrio in the U.S. and Albrioza in Canada, for ALS.\nPHOENIX did not meet its primary endpoint of reaching statistical significance (p=0.667) as measured by change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score at Week 48, nor was there statistical significance seen in secondary endpoints. \nPrice Action: AMLX stock is trading lower by 0.66% to $9.10 at last check Wednesday.\nRead Next:\nImage via Shutterstock","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}