Wave Life Sciences Reports 'Positive' Data for Prospective Duchenne Treatment; Shares Up Pre-Bell

MT Newswires Live03-26

Wave Life Sciences (WVE) shares were higher premarket Wednesday after the company reported "positive" 48-week data from a phase 2 trial of its WVE-N531 drug candidate in boys with Duchenne muscular dystrophy who are amenable to exon 53 skipping.

The biotechnology company said the boys received 10 milligrams of the exon skipping oligonucleotide every two weeks for each kilogram of their weight, with WVE-N531 meeting all trial goals, including sustained and industry-leading exon skipping, muscle concentrations and dystrophin restoration,

WVE-N531 also demonstrated a 61-day tissue half-life support in monthly dosing. It also continues to be safe and well-tolerated, the company said.

Wave also said it recently met with the US Food and Drug Administration to discuss its interim 24-week data and initial plans for a confirmatory phase 3 trial, with the agency confirming WVE-N531 remains on an accelerated approval pathway using dystrophin expression as a surrogate endpoint.

The company also expects to file a new drug application in 2026 for accelerated approval of WVE-N531 based on FDA feedback and the new 48-week data.

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/2522030806?lang=en_US&edition=full_marsco","thumbnail":"","is_english":true,"pubTime":"2025-03-26 21:20","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2522030806","market":"sh","top_or_hot":-1,"title":"Wave Life Sciences Reports 'Positive' Data for Prospective Duchenne Treatment; Shares Up Pre-Bell","media":"MT Newswires Live","content":"<html><body><p> Wave Life Sciences (WVE) shares were higher premarket Wednesday after the company reported \"positive\" 48-week data from a phase 2 trial of its WVE-N531 drug candidate in boys with Duchenne muscular dystrophy who are amenable to exon 53 skipping.</p><p>The biotechnology company said the boys received 10 milligrams of the exon skipping oligonucleotide every two weeks for each kilogram of their weight, with WVE-N531 meeting all trial goals, including sustained and industry-leading exon skipping, muscle concentrations and dystrophin restoration,</p><p>WVE-N531 also demonstrated a 61-day tissue half-life support in monthly dosing. It also continues to be safe and well-tolerated, the company said.</p><p>Wave also said it recently met with the US Food and Drug Administration to discuss its interim 24-week data and initial plans for a confirmatory phase 3 trial, with the agency confirming WVE-N531 remains on an accelerated approval pathway using dystrophin expression as a surrogate endpoint.</p><p>The company also expects to file a new drug application in 2026 for accelerated approval of WVE-N531 based on FDA feedback and the new 48-week data.</p></body></html>","source":"mtnewswires_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>Wave Life Sciences Reports 'Positive' Data for Prospective Duchenne Treatment; Shares Up Pre-Bell</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\">\nWave Life Sciences Reports 'Positive' Data for Prospective Duchenne Treatment; Shares Up Pre-Bell\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2025-03-26 21:20</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Wave Life Sciences (WVE) shares were higher premarket Wednesday after the company reported \"positive\" 48-week data from a phase 2 trial of its WVE-N531 drug candidate in boys with Duchenne muscular dystrophy who are amenable to exon 53 skipping.</p><p>The biotechnology company said the boys received 10 milligrams of the exon skipping oligonucleotide every two weeks for each kilogram of their weight, with WVE-N531 meeting all trial goals, including sustained and industry-leading exon skipping, muscle concentrations and dystrophin restoration,</p><p>WVE-N531 also demonstrated a 61-day tissue half-life support in monthly dosing. It also continues to be safe and well-tolerated, the company said.</p><p>Wave also said it recently met with the US Food and Drug Administration to discuss its interim 24-week data and initial plans for a confirmatory phase 3 trial, with the agency confirming WVE-N531 remains on an accelerated approval pathway using dystrophin expression as a surrogate endpoint.</p><p>The company also expects to file a new drug application in 2026 for accelerated approval of WVE-N531 based on FDA feedback and the new 48-week data.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"WVE","symbol_name":"Wave Life Sciences Pte. Ltd","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2522030806","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2522030806","pubTimestamp":1742995203,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Wave Life Sciences  shares were higher premarket Wednesday after the company reported \"positive\" 48-week data from a phase 2 trial of its WVE-N531 drug candidate in boys with Duchenne muscular dystrophy who are amenable to exon 53 skipping.The biotechnology company said the boys received 10 milligrams of the exon skipping oligonucleotide every two weeks for each kilogram of their weight, with WVE-N531 meeting all trial goals, including sustained and industry-leading exon skipping, muscle concentrations and dystrophin restoration,WVE-N531 also demonstrated a 61-day tissue half-life support in monthly dosing. It also continues to be safe and well-tolerated, the company said.Wave also said it recently met with the US Food and Drug Administration to discuss its interim 24-week data and initial plans for a confirmatory phase 3 trial, with the agency confirming WVE-N531 remains on an accelerated approval pathway using dystrophin expression as a surrogate endpoint.The company also expects to ","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"WVE":"Wave Life Sciences Pte. Ltd","BK4007":"制药"},"translate_title":"Wave Life Sciences报告了前瞻性杜氏治疗的“积极”数据；分享盘前","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"WVE":0.9},"content_text":"Wave Life Sciences (WVE) shares were higher premarket Wednesday after the company reported \"positive\" 48-week data from a phase 2 trial of its WVE-N531 drug candidate in boys with Duchenne muscular dystrophy who are amenable to exon 53 skipping.The biotechnology company said the boys received 10 milligrams of the exon skipping oligonucleotide every two weeks for each kilogram of their weight, with WVE-N531 meeting all trial goals, including sustained and industry-leading exon skipping, muscle concentrations and dystrophin restoration,WVE-N531 also demonstrated a 61-day tissue half-life support in monthly dosing. It also continues to be safe and well-tolerated, the company said.Wave also said it recently met with the US Food and Drug Administration to discuss its interim 24-week data and initial plans for a confirmatory phase 3 trial, with the agency confirming WVE-N531 remains on an accelerated approval pathway using dystrophin expression as a surrogate endpoint.The company also expects to file a new drug application in 2026 for accelerated approval of WVE-N531 based on FDA feedback and the new 48-week data.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"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":"4.33.2","shortVersion":"4.33.2","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/2522030806"}