{"id":69802,"date":"2026-08-24T18:41:18","date_gmt":"2026-08-24T18:41:18","guid":{"rendered":"https:\/\/www.europesays.com\/news\/69802\/"},"modified":"2026-08-24T18:41:18","modified_gmt":"2026-08-24T18:41:18","slug":"fda-pauses-regenxbio-hunter-syndrome-gene-therapy-trial","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/news\/69802\/","title":{"rendered":"FDA pauses Regenxbio Hunter syndrome gene therapy trial"},"content":{"rendered":"<p class=\"wp-block-paragraph\">The Food and Drug Administration has again paused trials for Regenxbio\u2019s gene therapy for a rare childhood brain disorder, after small masses were found on the spines of five patients, the company said Monday.<\/p>\n<p class=\"wp-block-paragraph\">Regenxbio said the patients, who have mucopolysaccharidosis (MPS) type II or Hunter syndrome, did not have any symptoms related to the masses.<\/p>\n<p class=\"wp-block-paragraph\">The announcement comes seven months after Regenxbio announced that one boy who received a very similar therapy the company developed for MPS type I developed a brain tumor. It was the first tumor to be conclusively <a href=\"https:\/\/www.statnews.com\/2026\/05\/13\/gene-therapy-cancer-risks-mps-hurler-syndrome\/\" rel=\"nofollow noopener\" target=\"_blank\">linked<\/a> to AAV gene therapy, the form of gene therapy most commonly used over the past 20 years.<\/p>\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.europesays.com\/news\/wp-content\/uploads\/2026\/03\/stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" rel=\"nofollow noopener\" target=\"_blank\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 plus daily coverage and analysis of the biotech sector \u2014 by subscribing to STAT+.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" rel=\"nofollow noopener\" target=\"_blank\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" rel=\"nofollow noopener\" target=\"_blank\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The Food and Drug Administration has again paused trials for Regenxbio\u2019s gene therapy for a rare childhood brain&hellip;\n","protected":false},"author":2,"featured_media":43834,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[4],"tags":[1433,2112,8,9,24949,2400,7],"class_list":["post-69802","post","type-post","status-publish","format-standard","has-post-thumbnail","category-top-stories","tag-biotechnology","tag-drug-development","tag-headlines","tag-news","tag-rare-disease","tag-stat","tag-top-stories"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@news\/117151956017434647","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts\/69802","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/comments?post=69802"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts\/69802\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/media\/43834"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/media?parent=69802"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/categories?post=69802"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/tags?post=69802"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}