Fractyl Health Inc. Submits First Clinical Trial Application Module in Europe for RJVA-001 Gene Therapy in Type 2 Diabetes

Reuters

2025/05/19

<a href="https://laohu8.com/S/GUTS">Fractyl Health</a> Inc. Submits First Clinical Trial Application Module in Europe for RJVA-001 Gene Therapy in Type 2 Diabetes

BURLINGTON, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS), a company specializing in metabolic therapeutics, has announced the submission of the first module of its Clinical Trial Application $(CTA.UK)$ in Europe for RJVA-001. This gene therapy candidate from Fractyl's Rejuva platform aims to address type 2 diabetes and obesity by expressing glucagon-like peptide-1 (GLP-1) locally in pancreatic beta cells. The therapy is designed to enable physiologic hormone secretion without the high circulating levels associated with current systemic GLP-1 drug therapies, potentially reducing side effects. Pending regulatory clearance, Fractyl plans to begin first-in-human dosing and report preliminary data in 2026. The study will assess the safety, tolerability, and early efficacy of this one-time, pancreas-targeted gene therapy in patients with inadequately controlled type 2 diabetes and obesity.

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. Fractyl Health Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9453194-en) on May 19, 2025, and is solely responsible for the information contained therein.

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Submits First Clinical Trial Application Module in Europe for RJVA-001 Gene Therapy in Type 2 Diabetes\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\">2025-05-19 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      <a href=\"https://laohu8.com/S/GUTS\">Fractyl Health</a> Inc. Submits First Clinical Trial Application Module in Europe for RJVA-001 Gene Therapy in Type 2 Diabetes\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        BURLINGTON, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS), a company specializing in metabolic therapeutics, has announced the submission of the first module of its Clinical Trial Application <a href=\"https://laohu8.com/S/CTA.UK\">$(CTA.UK)$</a> in Europe for RJVA-001. This gene therapy candidate from Fractyl's Rejuva platform aims to address type 2 diabetes and obesity by expressing glucagon-like peptide-1 (GLP-1) locally in pancreatic beta cells. The therapy is designed to enable physiologic hormone secretion without the high circulating levels associated with current systemic GLP-1 drug therapies, potentially reducing side effects. Pending regulatory clearance, Fractyl plans to begin first-in-human dosing and report preliminary data in 2026. The study will assess the safety, tolerability, and early efficacy of this one-time, pancreas-targeted gene therapy in patients with inadequately controlled type 2 diabetes and obesity.\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. Fractyl Health Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9453194-en) on May 19, 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:20250519:nNDL4q6hJN:1","article_id":"2536683047","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2536683047","pubTimestamp":1747652415,"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":"BURLINGTON, Mass., May 19, 2025  -- Fractyl Health, Inc. , a company specializing in metabolic therapeutics, has announced the submission of the first module of its Clinical Trial Application  in Europe for RJVA-001. This gene therapy candidate from Fractyl's Rejuva platform aims to address type 2 diabetes and obesity by expressing glucagon-like peptide-1  locally in pancreatic beta cells. The therapy is designed to enable physiologic hormone secretion without the high circulating levels associated with current systemic GLP-1 drug therapies, potentially reducing side effects. Pending regulatory clearance, Fractyl plans to begin first-in-human dosing and report preliminary data in 2026. The study will assess the safety, tolerability, and early efficacy of this one-time, pancreas-targeted gene therapy in patients with inadequately controlled type 2 diabetes and obesity.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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The study will assess the safety, tolerability, and early efficacy of this one-time, pancreas-targeted gene therapy in patients with inadequately controlled type 2 diabetes and obesity.\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. Fractyl Health Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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