Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected

Benzinga01-08

On Monday, Denali Therapeutics Inc. (NASDAQ:DNLI) revealed topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for amyotrophic lateral sclerosis....

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(NASDAQ:DNLI) revealed topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for amyotrophic lateral sclerosis....</p>\n\n<a href=\"https://finance.yahoo.com/news/denali-therapeutics-amyotrophic-lateral-sclerosis-174832467.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","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>Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected</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\">\nDenali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-01-08 01:48 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/denali-therapeutics-amyotrophic-lateral-sclerosis-174832467.html><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>On Monday, Denali Therapeutics Inc. (NASDAQ:DNLI) revealed topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for amyotrophic lateral sclerosis....</p>\n\n<a href=\"https://finance.yahoo.com/news/denali-therapeutics-amyotrophic-lateral-sclerosis-174832467.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":null,"symbol_name":null,"start_time":0,"source_url":"https://finance.yahoo.com/news/denali-therapeutics-amyotrophic-lateral-sclerosis-174832467.html","article_id":"2501733775","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2501733775","pubTimestamp":1736272112,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"On Monday, Denali Therapeutics Inc. revealed topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for amyotrophic lateral sclerosis.Compared to placebo, the study did not meet the primary endpoint of efficacy in slowing disease progression.The primary endpoint was evaluated as a change in disease severity over time as measured by the ALS Functional Rating Scale-Revised  and survival through week 24.Also Read: Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic. Key secondary endpoints, measuring muscle strength and respiratory function, were also not statistically different between the active and placebo groups at week 24.Overall, DNL343 was found to be safe and well-tolerated. Further analyses are anticipated later in 2025, including neurofilament light  and other fluid biomarkers, data from pre-specified subgroups, and extended findings from the active treatment extension period.William Blair noted tha","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{},"translate_title":"Denali Therapeutics的肌萎缩侧索硬化症错过了关键试验，但分析师表示这在意料之中","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BIIB":1,"LENZ":1,"IONS":1,"DNLI":0.9,".IXIC":0.72,"USJW.SI":0.6,"NVIW.SI":0.6,"PSQ":0.6,"QID":0.6,"QLD":0.6,"SQQQ":0.6,"TQQQ":0.6,"TSYW.SI":0.6,"USAW.SI":0.6,"MNQmain":0.6,"NQmain":0.6},"content_text":"On Monday, Denali Therapeutics Inc. (NASDAQ:DNLI) revealed topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for amyotrophic lateral sclerosis.\nCompared to placebo, the study did not meet the primary endpoint of efficacy in slowing disease progression.\nThe primary endpoint was evaluated as a change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) and survival through week 24.\nAlso Read: Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic\nKey secondary endpoints, measuring muscle strength and respiratory function, were also not statistically different between the active and placebo groups at week 24.\nFor the primary analysis, 186 participants who were randomized to receive DNL343 treatment were compared to 139 participants randomized to receive placebo in this regimen (n=63) or shared from a concurrently enrolling regimen (n=76).\nOverall, DNL343 was found to be safe and well-tolerated. Further analyses are anticipated later in 2025, including neurofilament light (NfL) and other fluid biomarkers, data from pre-specified subgroups, and extended findings from the active treatment extension period.\nWilliam Blair noted that while the update is disappointing for patients and investors, it isn’t entirely unexpected. This is due to the short treatment period and the complexity of the disease, which has a history of clinical trial challenges.\nBiogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) faced a similar situation with Qalsody, which failed to show significant improvement in ALSFRS-R scores over six months. However, it eventually received accelerated approval based on reduced NfL levels and indications of benefit with early treatment over 52 weeks.\nAnalyst Sarah Schram believes it’s too soon to abandon the program and is awaiting a more detailed analysis, expected in late 2025.\nPrice Action: DNLI stock is up 7.29% at $21.27 at the last check on Tuesday.\nRead Next:\n\nUniFirst Shares Skyrocket As Cintas Reveals $275 Per Share Acquisition Offer\n\nLatest Ratings for DNLI\n\n\n\nDate\nFirm\nAction\nFrom\nTo\n\n\n\n\nJan 2022\nMorgan Stanley\nMaintains\n\nOverweight\n\n\nSep 2021\nOppenheimer\nInitiates Coverage On\n\nOutperform\n\n\nAug 2021\nMorgan Stanley\nMaintains\n\nOverweight\n\n\n\n View More Analyst Ratings for DNLI \n View the Latest Analyst Ratings \nUNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets.\nGet the latest stock analysis from Benzinga?\n\nThis article Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected originally appeared on Benzinga.com\n© 2025 Benzinga.com. Benzinga does not provide investment advice. 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