Charles River Laboratories and Elly's Team Secure FDA Approval for Pioneering Gene Therapy Targeting Rare Neurodevelopmental Disorder

Reuters

2025/07/22

Charles River Laboratories and Elly's Team Secure FDA Approval for Pioneering Gene Therapy Targeting Rare Neurodevelopmental Disorder

Charles River Laboratories International Inc. has announced a significant milestone in the development of gene therapy for rare diseases, as part of a collaborative effort with Elly's Team, a parent-led foundation. The partnership has successfully navigated the Food and Drug Administration (FDA) approval process, receiving Investigational New Drug $(IND.AU)$ approval in March 2025. This approval enabled the first administration of IRF2BPL gene replacement therapy to a child named Elly on April 3, 2025. This achievement is a result of combined efforts and expertise from multiple organizations, including Charles River, which provided critical support in manufacturing and advisory services. The collaboration marks a pivotal moment for the IRF2BPL community, offering hope and a path to treatment for families facing similar diagnoses.

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. Charles River Laboratories International Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250722374711) on July 22, 2025, and is solely responsible for the information contained therein.

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The partnership has successfully navigated the Food and Drug Administration (FDA) approval process, receiving Investigational New Drug <a href=\"https://laohu8.com/S/IND.AU\">$(IND.AU)$</a> approval in March 2025. This approval enabled the first administration of IRF2BPL gene replacement therapy to a child named Elly on April 3, 2025. This achievement is a result of combined efforts and expertise from multiple organizations, including Charles River, which provided critical support in manufacturing and advisory services. The collaboration marks a pivotal moment for the IRF2BPL community, offering hope and a path to treatment for families facing similar diagnoses.\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. Charles River Laboratories International Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250722374711) on July 22, 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":"LU1815336091.USD","symbol_name":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AUP\" (USD) INC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250722:nNDLbfZPtR:1","article_id":"2553825311","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2553825311","pubTimestamp":1753185649,"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":"Charles River Laboratories and Elly's Team Secure FDA Approval for Pioneering Gene Therapy Targeting Rare Neurodevelopmental Disorder. 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