{"id":916156,"date":"2025-12-04T07:08:08","date_gmt":"2025-12-04T12:08:08","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/"},"modified":"2025-12-04T07:08:08","modified_gmt":"2025-12-04T12:08:08","slug":"uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/","title":{"rendered":"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">LEXINGTON, Mass. and AMSTERDAM, Dec.  04, 2025  (GLOBE NEWSWIRE) &#8212; <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bcldnQDA4YY4f1EpXOH83UbTY6GHmwRT32OWYDdYnRjvdwn6KYV0QyDnMdkyZ3qMtoRUmStCqakVqyhfNL-_GQ==\" rel=\"nofollow\" target=\"_blank\">uniQure<\/a> N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntington\u2019s disease (HD). \u00a0<\/p>\n<p align=\"justify\">In the final meeting minutes, and consistent with uniQure\u2019s November 3, 2025 press release, the FDA conveyed that data submitted from the Phase I\/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission. uniQure is carefully evaluating the feedback and plans to urgently request a follow-up meeting with the FDA to take place in the first quarter of 2026.<\/p>\n<p align=\"justify\">\u201cWe are committed to collaborating with the FDA to advance AMT-130 to patients and their families as rapidly as possible,\u201d said <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=AsG0YhSXWPNZa3uaWCRwqdQ-qDIKWqo2EW2PRZk3zQc5kRFPF2gv329uACIIyF8s2y_kUFQSvdSMq4Sa3SxUuGjhktxtHT5bcdzDAKpAlB8USNcPF0fjqCJ-4n4cTt17OZIAAsSr2AH_bJDwR6RW_B_qnPld4YX-0u2OVhviTAw=\" rel=\"nofollow\" target=\"_blank\">Matt Kapusta, chief executive officer at uniQure<\/a>. \u201cThe support we have seen these last weeks from the Huntington\u2019s disease community, including patients, families, caregivers, clinicians and advocates reinforces the urgency of the unmet need in Huntington\u2019s disease.\u201d<\/p>\n<p align=\"justify\">\n        <strong>About uniQure <\/strong>\n      <\/p>\n<p align=\"justify\">uniQure is delivering on the promise of gene therapy \u2013 single treatments with potentially curative results. The approvals of uniQure\u2019s gene therapy for hemophilia B \u2013 an historic achievement based on more than a decade of research and clinical development \u2013 represent a major milestone in the field of genomic medicine and ushers in a new treatment approach for patients living with hemophilia. uniQure is now advancing a <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=MWtWcAlQ5sjXC-UhFIXmDc-bWruWIYrClYJJSvhKA_9XKeNW3ukAjJkyjQs0zGLcUnHYnPZDEQLPuiDssso7OccAhU9HowrYMqJ8Y7eqDDvj-ttQp2hQPapNOY4SkI4m\" rel=\"nofollow\" target=\"_blank\">pipeline<\/a> of proprietary gene therapies for the treatment of patients with Huntington&#8217;s disease, refractory temporal lobe epilepsy, ALS, Fabry disease, and other severe diseases.\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=RHWt8rJR5bwenLmOHl_pYYXautjHSvmMkH8txsm_R6akoehdmAm2-yMxoRBXa9PmByAI6T29tkwfLamI4ZPf7Q==\" rel=\"nofollow\" target=\"_blank\">www.uniQure.com<\/a><\/p>\n<p align=\"justify\">\n        <strong>uniQure Forward-Looking Statements<\/strong>\n      <\/p>\n<p align=\"justify\">\n        <em>This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;could,&#8221; \u201cestablish,\u201d &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;goal,&#8221; &#8220;intend,&#8221; &#8220;look forward to&#8221;, &#8220;may,&#8221; &#8220;plan,&#8221; &#8220;potential,&#8221; &#8220;predict,&#8221; &#8220;project,&#8221; \u201cseek,\u201d &#8220;should,&#8221; &#8220;will,&#8221; &#8220;would&#8221; and similar expressions and the negatives of those terms. Forward-looking statements are based on management&#8217;s beliefs and assumptions and on information available to management as of the date of this press release. Examples of these forward-looking statements include, but are not limited to, statements concerning: the Company\u2019s <\/em><br \/>\n        <em>plans <\/em><br \/>\n        <em>to request a follow-up meeting with the FDA to take place in the first quarter of 2026 and to <\/em><br \/>\n        <em>collaborate with the FDA to advance AMT-130 to patients and families,<\/em><br \/>\n        <em> and the timing and outcome of regulatory interactions with respect to the AMT-130 program. The Company\u2019s actual results could differ materially from those anticipated in these forward-looking statements for many reasons.\u00a0These risks and uncertainties include, among others: risks related to the Company\u2019s Phase I\/ll clinical trials of AMT-130, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval;<\/em><br \/>\n        <em>the risk that the FDA ultimately concludes that such trials are not adequate and well-controlled to provide the primary evidence to support a BLA;<\/em><br \/>\n        <em>the risk that more patient data become available that results in a different interpretation then the one derived from the topline data; risks related to the Company\u2019s interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval; whether the measurements that the Company is evaluating are viewed as robust and sensitive measurements of disease progression; whether RMAT designation, Breakthrough Therapy designation, or any accelerated pathway, if granted, will lead to regulatory approval; the Company\u2019s ability to conduct and fund a Phase III or confirmatory study for AMT-130 if needed; the Company\u2019s ability to continue to build and maintain the infrastructure and personnel needed to achieve its goals; the Company\u2019s effectiveness in managing current and future clinical trials and regulatory processes; the Company\u2019s ability to demonstrate the therapeutic benefits of its gene therapy candidates in clinical trials; the continued development and acceptance of gene therapies; the Company\u2019s ability to obtain, maintain and protect its intellectual property; and the Company\u2019s ability to fund its operations and to raise additional capital as needed and on acceptable terms. These risks and uncertainties are more fully described under the heading &#8220;Risk Factors&#8221; in the Company\u2019s periodic filings with the U.S. Securities &amp; Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on February 27, 2025, its Quarterly Reports on Form 10-Q filed with the SEC on May 9, 2025, and July 29, 2025, and November 10, 2025 and in other filings that the Company makes with the SEC from time to time. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements and, except as required by law, the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.<\/em>\n      <\/p>\n<table style=\"border-collapse: collapse;width:100.011%;border-collapse:collapse\">\n<tr>\n<td style=\"width:49.9943%;text-align: justify;vertical-align: middle;vertical-align: top\">\n            <strong>uniQure Contacts:<\/strong>\n          <\/td>\n<td style=\"width:49.9943%;vertical-align: top\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"width:49.9943%\">\u00a0<\/td>\n<td style=\"width:49.9943%\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"width:49.9943%;vertical-align: top\">\n            <strong>FOR INVESTORS:<\/strong>\n          <\/td>\n<td style=\"width:49.9943%;text-align: justify;vertical-align: middle;vertical-align: top\">\n            <strong>FOR MEDIA:<\/strong>\n          <\/td>\n<\/tr>\n<tr>\n<td style=\"width:49.9943%\">\u00a0<\/td>\n<td style=\"width:49.9943%\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"width:49.9943%;vertical-align: top\">\n            <strong>Chiara Russo<\/strong><br \/>\n            <br \/>Direct: 781-491-4371<br \/>Mobile: 617-306-9137\u00a0<br \/><a href=\"mailto:c.russo@uniQure.com\" rel=\"nofollow\" target=\"_blank\">c.russo@uniQure.com<\/a><br \/>\u00a0<\/td>\n<td style=\"width:49.9943%;vertical-align: top\">\n            <strong>Tom Malone<br \/><\/strong>Direct: 339-970-7558<br \/>Mobile: 339-223-8541<br \/><a href=\"mailto:t.malone@uniQure.com\" rel=\"nofollow\" target=\"_blank\">t.malone@uniQure.com<\/a><strong><br \/><\/strong><\/td>\n<\/tr>\n<\/table>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU5NjcwMiM3MzA1NzA2IzIwODA0MDY=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/YTk5NTJlOTUtMGJmYi00MWNmLTkyZjItMDIyNTdlMzU2NjRjLTEwOTE5NzctMjAyNS0xMi0wNC1lbg==\/tiny\/uniQure-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) &#8212; uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntington\u2019s disease (HD). \u00a0 In the final meeting minutes, and consistent with uniQure\u2019s November 3, 2025 press release, the FDA conveyed that data submitted from the Phase I\/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission. uniQure is carefully evaluating the feedback and plans &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-916156","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) &#8212; uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntington\u2019s disease (HD). \u00a0 In the final meeting minutes, and consistent with uniQure\u2019s November 3, 2025 press release, the FDA conveyed that data submitted from the Phase I\/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission. uniQure is carefully evaluating the feedback and plans &hellip; Continue reading &quot;uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-04T12:08:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU5NjcwMiM3MzA1NzA2IzIwODA0MDY=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease\",\"datePublished\":\"2025-12-04T12:08:08+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\\\/\"},\"wordCount\":858,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTU5NjcwMiM3MzA1NzA2IzIwODA0MDY=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\\\/\",\"name\":\"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/","og_locale":"en_US","og_type":"article","og_title":"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease - Market Newsdesk","og_description":"LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) &#8212; uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntington\u2019s disease (HD). \u00a0 In the final meeting minutes, and consistent with uniQure\u2019s November 3, 2025 press release, the FDA conveyed that data submitted from the Phase I\/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission. uniQure is carefully evaluating the feedback and plans &hellip; Continue reading \"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/","og_site_name":"Market Newsdesk","article_published_time":"2025-12-04T12:08:08+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU5NjcwMiM3MzA1NzA2IzIwODA0MDY=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease","datePublished":"2025-12-04T12:08:08+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/"},"wordCount":858,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU5NjcwMiM3MzA1NzA2IzIwODA0MDY=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-2\/","name":"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease - 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