Sage Therapeutics Announces Topline Results from the Phase 2 DIMENSION Study of Dalzanemdor (SAGE-718) in the Treatment of Cognitive Impairment Associated with Huntington’s Disease

Business Wire11-20 19:30

The Phase 2 DIMENSION Study did not meet its primary endpoint Dalzanemdor was generally well-tolerated; no new safety signals were observed Based on these data, the Company does not plan further ...

Source Link

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/2484944331?lang=en_US&edition=fundamental","thumbnail":"https://s.yimg.com/uu/api/res/1.2/jlqGxr4P6ViRdaWAih_NWg--~B/aD0xMzg3O3c9NDQwMDthcHBpZD15dGFjaHlvbg--/https://media.zenfs.com/en/business-wire.com/8cccd96bb5295af2aa0755b54379f770","is_english":true,"pubTime":"2024-11-20 19:30","share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","id":"2484944331","market":"us","top_or_hot":-1,"title":"Sage Therapeutics Announces Topline Results from the Phase 2 DIMENSION Study of Dalzanemdor (SAGE-718) in the Treatment of Cognitive Impairment Associated with Huntington’s Disease","media":"Business Wire","content":"<div>\n<p>The Phase 2 DIMENSION Study did not meet its primary endpoint\nDalzanemdor was generally well-tolerated; no new safety signals were observed\nBased on these data, the Company does not plan further ...</p>\n\n<a href=\"https://finance.yahoo.com/news/sage-therapeutics-announces-topline-results-113000535.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>Sage Therapeutics Announces Topline Results from the Phase 2 DIMENSION Study of Dalzanemdor (SAGE-718) in the Treatment of Cognitive Impairment Associated with Huntington’s Disease</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\">\nSage Therapeutics Announces Topline Results from the Phase 2 DIMENSION Study of Dalzanemdor (SAGE-718) in the Treatment of Cognitive Impairment Associated with Huntington’s Disease\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-20 19:30 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/sage-therapeutics-announces-topline-results-113000535.html><strong>Business Wire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>The Phase 2 DIMENSION Study did not meet its primary endpoint\nDalzanemdor was generally well-tolerated; no new safety signals were observed\nBased on these data, the Company does not plan further ...</p>\n\n<a href=\"https://finance.yahoo.com/news/sage-therapeutics-announces-topline-results-113000535.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":"LU1261432733.SGD","symbol_name":"Fidelity World A-ACC-SGD","start_time":0,"source_url":"https://finance.yahoo.com/news/sage-therapeutics-announces-topline-results-113000535.html","article_id":"2484944331","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/jlqGxr4P6ViRdaWAih_NWg--~B/aD0xMzg3O3c9NDQwMDthcHBpZD15dGFjaHlvbg--/https://media.zenfs.com/en/business-wire.com/8cccd96bb5295af2aa0755b54379f770"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2484944331","pubTimestamp":1732102200,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"The Phase 2 DIMENSION Study did not meet its primary endpoint. Dalzanemdor was generally well-tolerated; no new safety signals were observed. Based on these data, the Company does not plan further development of dalzanemdor. CAMBRIDGE, Mass., November 20, 2024----Sage Therapeutics, Inc.  today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor  in participants with cognitive impairment  associated with Huntington’s Disease . In the study, dalzanemdor did not demonstrate a statistically significant difference versus placebo on the primary endpoint, the change from baseline on the Symbol Digit Modalities Test  at Day 84. Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences in participants treated with dalzanemdor compared to placebo. Based on these results, the Company does not plan further development of dalzanemdor.\"We are disappointed by the results of the DIMENSION Study, especially for the individua","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1261432733.SGD":"Fidelity World A-ACC-SGD","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU0820561909.HKD":"ALLIANZ INCOME AND GROWTH \"AM\" (HKD) INC","LU0820562030.AUD":"ALLIANZ INCOME AND GROWTH \"AMH2\" (AUDHDG) H2 INC","LU0320765646.SGD":"FTIF - Franklin Income A MDIS SGD-H1","SAGE":"Sage Therapeutics","LU0058720904.USD":"联博国际健康护理基金A","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","LU2756315664.SGD":"ALLIANZ INCOME AND GROWTH \"AMI\" (SGDHDG) INC","BK4567":"ESG概念","BK4534":"瑞士信贷持仓","BK4585":"ETF&股票定投概念","BK4139":"生物科技","IE00BWXC8680.SGD":"PINEBRIDGE US LARGE CAP RESEARCH ENHANCED \"A5\" (SGD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","HD":"家得宝","LU0689472784.USD":"安联收益及增长基金Cl AM AT Acc","BK4566":"资本集团","LU0868494708.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) INC","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","BK4196":"保健护理服务","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","CI":"信诺保险","LU1674673428.USD":"HSBC GIF GLOBAL LOWER CARBON EQUITY \"AC\" (USD) ACC","LU1496350171.SGD":"FRANKLIN DIVERSIFIED BALANCED \"A\" (SGDHDG) ACC","LU0823434583.USD":"BNP PARIBAS US GROWTH \"C\" (USD) ACC","LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","LU1778281490.HKD":"HSBC GIF GLOBAL LOWER CARBON EQUITY \"AD\" (HKD) INC","LU0823434740.USD":"BNP PARIBAS US GROWTH \"C\" (USD) INC","LU0354030511.USD":"ALLSPRING  U.S. LARGE CAP GROWTH \"I\" (USD) ACC","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","BK4550":"红杉资本持仓","LU0354030438.USD":"富国美国大盘成长基金Cl A Acc","LU1551013425.SGD":"Allianz Income and Growth Cl AMg2 DIS H2-SGD","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU1035775433.USD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (USD) INC","LU2756315318.SGD":"ALLIANZ INCOME AND GROWTH \"AMG\" (SGDHDG) INC A","LU1496350502.SGD":"FRANKLIN DIVERSIFIED DYNAMIC \"A\" (SGDHDG) ACC","BK4083":"家庭装潢零售","LU1929549753.HKD":"FRANKLIN INCOME \"A\" (HKD) INC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","BK4504":"桥水持仓","LU0942090050.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD)  INC","LU1162221912.USD":"FRANKLIN INCOME \"A\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0823411888.USD":"法巴消费创新基金 Cap","LU0079474960.USD":"联博美国增长基金A","LU1989772840.SGD":"CPR Invest - Climate Action A2 Acc SGD-H","IE00B1XK9C88.USD":"PINEBRIDGE US LARGE CAP RESEARCH ENHANCED \"A\" (USD) ACC","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD"},"translate_title":"Sage Therapeutics宣布Dalzanemdor(SAGE-718)治疗亨廷顿舞蹈症相关认知障碍的2期DIMENSION研究的顶线结果","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SAGE":1,"CI":1,"HD":1},"content_text":"The Phase 2 DIMENSION Study did not meet its primary endpoint\nDalzanemdor was generally well-tolerated; no new safety signals were observed\nBased on these data, the Company does not plan further development of dalzanemdor\nCAMBRIDGE, Mass., November 20, 2024--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive impairment (CI) associated with Huntington’s Disease (HD). In the study, dalzanemdor did not demonstrate a statistically significant difference versus placebo on the primary endpoint, the change from baseline on the Symbol Digit Modalities Test (SDMT) at Day 84. Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences in participants treated with dalzanemdor compared to placebo. Based on these results, the Company does not plan further development of dalzanemdor.\n\"We are disappointed by the results of the DIMENSION Study, especially for the individuals and families affected by Huntington’s Disease who have long awaited new treatment options,\" said Barry Greene, Chief Executive Officer, Sage Therapeutics. \"Innovation is desperately needed, and we are immensely grateful to the participants, investigators, and the entire Huntington’s Disease community whose unwavering commitment to advancing research helped make this study possible.\"\nDIMENSION Study Results\nThe DIMENSION Study was a 12-week, double-blind, placebo-controlled Phase 2 study to evaluate the effects of dalzanemdor in participants with CI associated with HD. A total of 189 participants were randomized.\n\nThe DIMENSION Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the SDMT, a measure of cognitive function, at Day 84, the primary endpoint.\nDalzanemdor was generally well-tolerated and no new safety signals were observed. The majority of treatment emergent adverse events were mild to moderate in severity.\nAnalyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences between the dalzanemdor and placebo treatment groups.\n\nGiven these findings, the Company also will close the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with HD.\nAbout Sage TherapeuticsSage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a pipeline to target unmet needs in brain health. Sage was founded in 2010 and is headquartered in Cambridge, Mass. Find out more at www.sagerx.com or engage with us on Facebook, LinkedIn, Instagram, and X.\nForward Looking Statements\nVarious statements in this release concern future expectations, plans and prospects, including without limitation statements regarding: our plan not to further develop dalzanemdor and to close the PURVIEW Study; our belief in the unmet need for new treatment options for brain health; and the mission, goals, opportunity and potential for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: the results of ongoing, planned or future clinical trials or nonclinical work with respect to any of our product candidates may be negative like the results we announced today from the DIMENSION Study; decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, or progress of ongoing or future clinical trials or the regulatory pathway for any of our product candidates or our ability to proceed with further development; we may encounter adverse results or adverse events at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; we may at any time encounter unexpected hurdles in the development and manufacture of our product candidates; and all of these factors and other developments related to our science or business could cause us not to achieve our mission or the goals for our business; as well as those risks more fully discussed in the section entitled \"Risk Factors\" in our most recent Quarterly Report on Form 10-Q, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. Sage explicitly disclaims any obligation to update any forward-looking statements.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241119012801/en/\nContacts\nMedia: Francesca DellelciFrancesca.Dellelci@sagerx.com\nInvestor: Katie PlanteKatie.Plante@sagerx.com","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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":"4.29.2","shortVersion":"4.29.2","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/2484944331"}