Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment

Reuters

2025/06/09

Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment

Avidity Biosciences Inc. has announced that the U.S. FDA has opened the accelerated approval regulatory pathway for their drug del-brax, targeting facioscapulohumeral muscular dystrophy (FSHD). This development paves the way for a planned accelerated approval Biologics License Application $(BLA.AU)$ submission in the second half of 2026, following topline data from the FORTITUDE™ biomarker cohort in the second quarter of 2026. Additionally, Avidity has initiated the global, confirmatory Phase 3 FORWARD™ study, involving approximately 200 participants across North America, Europe, and Japan. This study aims to evaluate the efficacy of del-brax in improving functional mobility and strength in individuals with FSHD. The initiation of this study marks a critical step in Avidity's strategy to secure global approval for del-brax.

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. Avidity Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA05504) on June 09, 2025, and is solely responsible for the information contained therein.

應版權方要求，你需要登入查看該內容

登入 / 註冊

免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。

熱議股票

1
2
3
4
5
6
7
8
9
10

{"basename":"/hant","ssrTDKData":{"titleTemplate":"%s - 老虎證券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎證券,老虎證券開戶,老虎券商,老虎證券官網,老虎證券app,tigertrade老虎證券,股票,炒股,新加坡股票交易平臺,投資,投資理財","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hant/news/2542386470"},"companyName":"老虎證券"},"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:\"2542386470\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2542386470?lang=zh_TW&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-06-09 19:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2542386470","market":"us","top_or_hot":-1,"title":"Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment","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      Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment\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        Avidity Biosciences Inc. has announced that the U.S. FDA has opened the accelerated approval regulatory pathway for their drug del-brax, targeting facioscapulohumeral muscular dystrophy (FSHD). This development paves the way for a planned accelerated approval Biologics License Application <a href=\"https://laohu8.com/S/BLA.AU\">$(BLA.AU)$</a> submission in the second half of 2026, following topline data from the FORTITUDE™ biomarker cohort in the second quarter of 2026. Additionally, Avidity has initiated the global, confirmatory Phase 3 FORWARD™ study, involving approximately 200 participants across North America, Europe, and Japan. This study aims to evaluate the efficacy of del-brax in improving functional mobility and strength in individuals with FSHD. The initiation of this study marks a critical step in Avidity's strategy to secure global approval for del-brax.\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. Avidity Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA05504) on June 09, 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>Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment</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: 12.5px; color: #7E829C; margin: 0;}\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\">\nAvidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\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 smaller\">2025-06-09 19:00</p>\n</div>\n</a>\n</h4>\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      Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment\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        Avidity Biosciences Inc. has announced that the U.S. FDA has opened the accelerated approval regulatory pathway for their drug del-brax, targeting facioscapulohumeral muscular dystrophy (FSHD). This development paves the way for a planned accelerated approval Biologics License Application <a href=\"https://laohu8.com/S/BLA.AU\">$(BLA.AU)$</a> submission in the second half of 2026, following topline data from the FORTITUDE™ biomarker cohort in the second quarter of 2026. Additionally, Avidity has initiated the global, confirmatory Phase 3 FORWARD™ study, involving approximately 200 participants across North America, Europe, and Japan. This study aims to evaluate the efficacy of del-brax in improving functional mobility and strength in individuals with FSHD. The initiation of this study marks a critical step in Avidity's strategy to secure global approval for del-brax.\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. Avidity Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA05504) on June 09, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\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:20250609:nNDL46Qzt5:1","article_id":"2542386470","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2542386470","pubTimestamp":1749466856,"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":"Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment. Disclaimer: This news brief was created by Public Technologies  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. Avidity Biosciences Inc. published the original content used to generate this news brief via PR Newswire  on June 09, 2025, and is solely responsible for the information contained therein.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4588":"碎股","BK4585":"ETF&股票定投概念","BK4505":"高瓴资本持仓","BK4139":"生物科技","RNA":"Atrium Therapeutics"},"translate_title":"Avidity Biosciences获得Del-Brax在美国的加速批准途径，并启动FSHD治疗的全球3期研究","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"RNA":0.9},"content_text":"Avidity Biosciences Secures Accelerated Approval Pathway for Del-Brax in the U.S. and Launches Global Phase 3 Study for FSHD Treatment\n    \n\n        Avidity Biosciences Inc. has announced that the U.S. FDA has opened the accelerated approval regulatory pathway for their drug del-brax, targeting facioscapulohumeral muscular dystrophy (FSHD). This development paves the way for a planned accelerated approval Biologics License Application $(BLA.AU)$ submission in the second half of 2026, following topline data from the FORTITUDE™ biomarker cohort in the second quarter of 2026. Additionally, Avidity has initiated the global, confirmatory Phase 3 FORWARD™ study, involving approximately 200 participants across North America, Europe, and Japan. This study aims to evaluate the efficacy of del-brax in improving functional mobility and strength in individuals with FSHD. The initiation of this study marks a critical step in Avidity's strategy to secure global approval for del-brax.\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. Avidity Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA05504) on June 09, 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":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}