Opus Genetics Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025

Reuters

Aug 18

<a href="https://laohu8.com/S/IRD">Opus Genetics</a> Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025

Opus Genetics Inc., a clinical-stage biopharmaceutical company specializing in gene therapies for inherited retinal diseases (IRDs), announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug $(IND.AU)$ application for OPGx-BEST1. This gene therapy candidate is designed to treat bestrophin-1 (BEST1)-related IRD, a rare inherited retinal condition leading to progressive vision loss. With this IND clearance, Opus Genetics plans to commence a Phase 1/2 clinical trial in the latter half of 2025. The trial will evaluate the safety, tolerability, and preliminary efficacy of a single subretinal injection of OPGx-BEST1, marking a significant advancement for patients with no currently approved treatments.

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. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9513657-en) on August 18, 2025, and is solely responsible for the information contained therein.

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.

Most Discussed

1
2
3
4
5
6
7
8
9
10

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www-web.itiger.com/news/2560902676"},"companyName":"Tiger Brokers"},"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:\"2560902676\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2560902676?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-08-18 20:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2560902676","market":"us","top_or_hot":-1,"title":"Opus Genetics Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025","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      <a href=\"https://laohu8.com/S/IRD\">Opus Genetics</a> Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025\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        Opus Genetics Inc., a clinical-stage biopharmaceutical company specializing in gene therapies for inherited retinal diseases (IRDs), announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug <a href=\"https://laohu8.com/S/IND.AU\">$(IND.AU)$</a> application for OPGx-BEST1. This gene therapy candidate is designed to treat bestrophin-1 (BEST1)-related IRD, a rare inherited retinal condition leading to progressive vision loss. With this IND clearance, Opus Genetics plans to commence a Phase 1/2 clinical trial in the latter half of 2025. The trial will evaluate the safety, tolerability, and preliminary efficacy of a single subretinal injection of OPGx-BEST1, marking a significant advancement for patients with no currently approved treatments.\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. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9513657-en) on August 18, 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>Opus Genetics Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025</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\">\nOpus Genetics Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\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\">2025-08-18 20:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\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      <a href=\"https://laohu8.com/S/IRD\">Opus Genetics</a> Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025\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        Opus Genetics Inc., a clinical-stage biopharmaceutical company specializing in gene therapies for inherited retinal diseases (IRDs), announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug <a href=\"https://laohu8.com/S/IND.AU\">$(IND.AU)$</a> application for OPGx-BEST1. This gene therapy candidate is designed to treat bestrophin-1 (BEST1)-related IRD, a rare inherited retinal condition leading to progressive vision loss. With this IND clearance, Opus Genetics plans to commence a Phase 1/2 clinical trial in the latter half of 2025. The trial will evaluate the safety, tolerability, and preliminary efficacy of a single subretinal injection of OPGx-BEST1, marking a significant advancement for patients with no currently approved treatments.\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. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9513657-en) on August 18, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00B3QW5Z07.USD","symbol_name":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250818:nNDL3v6W38:1","article_id":"2560902676","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2560902676","pubTimestamp":1755518427,"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":"Opus Genetics Inc., a clinical-stage biopharmaceutical company specializing in gene therapies for inherited retinal diseases , announced that the U.S. Food and Drug Administration  has granted clearance for its Investigational New Drug  application for OPGx-BEST1. This gene therapy candidate is designed to treat bestrophin-1 -related IRD, a rare inherited retinal condition leading to progressive vision loss. With this IND clearance, Opus Genetics plans to commence a Phase 1/2 clinical trial in the latter half of 2025. The trial will evaluate the safety, tolerability, and preliminary efficacy of a single subretinal injection of OPGx-BEST1, marking a significant advancement for patients with no currently approved treatments.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 finan","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","BK4588":"碎股","NDAQ":"纳斯达克OMX交易所","IRD":"OPUS GENETICS INC","BK4112":"金融交易所和数据","BK4585":"ETF&股票定投概念","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","BK4139":"生物科技","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","BK4007":"制药","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD"},"translate_title":"Opus Genetics获得OPGx-BEST1基因疗法FDA IND许可，为2025年启动1/2期试验铺平道路","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IRD":0.9,"NDAQ":0.9},"content_text":"Opus Genetics Secures FDA IND Clearance for OPGx-BEST1 Gene Therapy, Paving the Way for Phase 1/2 Trial Launch in 2025\n    \n\n        Opus Genetics Inc., a clinical-stage biopharmaceutical company specializing in gene therapies for inherited retinal diseases (IRDs), announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug $(IND.AU)$ application for OPGx-BEST1. This gene therapy candidate is designed to treat bestrophin-1 (BEST1)-related IRD, a rare inherited retinal condition leading to progressive vision loss. With this IND clearance, Opus Genetics plans to commence a Phase 1/2 clinical trial in the latter half of 2025. The trial will evaluate the safety, tolerability, and preliminary efficacy of a single subretinal injection of OPGx-BEST1, marking a significant advancement for patients with no currently approved treatments.\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. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9513657-en) on August 18, 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":false,"code":"91000000","status":"200"}}}