Regenxbio Inc. Announces Positive Interim Data from Phase I/II Trial of RGX-202 for Duchenne Muscular Dystrophy

Reuters

2025/06/05

<a href="https://laohu8.com/S/RGNX">Regenxbio Inc</a>. Announces Positive Interim Data from Phase I/II Trial of RGX-202 for Duchenne Muscular Dystrophy

REGENXBIO Inc. has announced positive interim data from its Phase I/II AFFINITY DUCHENNE trial involving RGX-202, a potential gene therapy for Duchenne muscular dystrophy. The trial results indicate consistent functional, safety, and biomarker benefits, with participants in dose level 2 surpassing external natural history controls on key functional measures. Biomarker data showed robust microdystrophin expression, with one participant achieving 118.6% expression compared to controls. The trial, which aims to enroll around 30 patients in the U.S. and Canada by 2025, supports a potential Biologics License Application submission using the accelerated approval pathway in mid-2026. REGENXBIO plans to release top-line data in the first half of 2026. A webcast discussing these developments is scheduled for 8:00 a.m. EST, accessible via the company's website.

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. Regenxbio Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH03647) on June 05, 2025, and is solely responsible for the information contained therein.

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Announces Positive Interim Data from Phase I/II Trial of RGX-202 for Duchenne Muscular Dystrophy","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/RGNX\">Regenxbio Inc</a>. Announces Positive Interim Data from Phase I/II Trial of RGX-202 for Duchenne Muscular Dystrophy\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        REGENXBIO Inc. has announced positive interim data from its Phase I/II AFFINITY DUCHENNE trial involving RGX-202, a potential gene therapy for Duchenne muscular dystrophy. The trial results indicate consistent functional, safety, and biomarker benefits, with participants in dose level 2 surpassing external natural history controls on key functional measures. 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Announces Positive Interim Data from Phase I/II Trial of RGX-202 for Duchenne Muscular Dystrophy\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\">2025-06-05 19:05</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/RGNX\">Regenxbio Inc</a>. Announces Positive Interim Data from Phase I/II Trial of RGX-202 for Duchenne Muscular Dystrophy\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        REGENXBIO Inc. has announced positive interim data from its Phase I/II AFFINITY DUCHENNE trial involving RGX-202, a potential gene therapy for Duchenne muscular dystrophy. The trial results indicate consistent functional, safety, and biomarker benefits, with participants in dose level 2 surpassing external natural history controls on key functional measures. Biomarker data showed robust microdystrophin expression, with one participant achieving 118.6% expression compared to controls. The trial, which aims to enroll around 30 patients in the U.S. and Canada by 2025, supports a potential Biologics License Application submission using the accelerated approval pathway in mid-2026. REGENXBIO plans to release top-line data in the first half of 2026. 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ID: PH03647) on June 05, 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":"RGNX","symbol_name":"Regenxbio Inc","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250605:nNDL6QN7gJ:1","article_id":"2541022359","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2541022359","pubTimestamp":1749121521,"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":"REGENXBIO Inc. has announced positive interim data from its Phase I/II AFFINITY DUCHENNE trial involving RGX-202, a potential gene therapy for Duchenne muscular dystrophy. 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