{"id":925789,"date":"2026-01-09T07:58:00","date_gmt":"2026-01-09T12:58:00","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/"},"modified":"2026-01-09T07:58:00","modified_gmt":"2026-01-09T12:58:00","slug":"uniqure-announces-type-a-meeting-scheduled-with-fda","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/","title":{"rendered":"uniQure Announces Type A Meeting Scheduled with FDA"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">LEXINGTON, Mass. and AMSTERDAM, Jan.  09, 2026  (GLOBE NEWSWIRE) &#8212; <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Y1_Pla6yfxpmgIJ3lPQ177y_LJpPSWwPi-bMsJSehH4szLdSWdZgvScAhxAzNV8VQRgJsTzrbPaIrDBNtoM8Ng==\" 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 a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Biologics License Application (BLA) data package to support accelerated approval of AMT-130, the Company\u2019s investigational gene therapy for the treatment of Huntington\u2019s disease.<\/p>\n<p align=\"justify\">\u201cWe look forward to a constructive discussion with the FDA as we work toward a timely resolution regarding an accelerated approval pathway for AMT-130,\u201d said <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=b2OYp2AGjL0TyofFy20h1Ejwqp0ijBy7WHRn-sJdJqdZAjo1HgIp22QFlVRi-Qiq_cuph7MECeo0kfbq_9SRSRbexd2shh5nh-OtxzvkmJEJ1-jprMRmgbkSKaZcpfOXs-5Vl2zPNCu6oakU4ZF7-65J4NN8DL42xbxyq8-wBMM=\" rel=\"nofollow\" target=\"_blank\">Matt Kapusta, chief executive officer at uniQure<\/a>. \u201cThe Huntington\u2019s disease community, including patients and clinicians, has emphasized the profound unmet medical need and the importance of timely access to potentially disease-modifying therapies such as AMT-130. We remain deeply committed to patient access while continuing to collaborate closely with the FDA.\u201d<\/p>\n<p align=\"justify\">The Company expects to provide a regulatory update after the receipt of official meeting minutes.<\/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=lS7CqTvgRCoqXraIQsJx7LXinfQHcDPxTXdsZt-m3A_CjeX5Vz3bxsT24yrLRAmHpA1fceC7g385kdGblWiyI8-Cwd3Fp2kKuk-DQX_kNz7TwZFUfvuqNyphFEhLXhKY\" rel=\"nofollow\" target=\"_blank\">pipeline<\/a> of proprietary gene therapies for the treatment of patients with Huntington\u2019s disease, refractory temporal lobe epilepsy, ALS, Fabry disease, and other severe diseases.\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=OMIc2dINCuRv8D8PhbT6FVXIKNUMN2-08FqGeJJrhkvarfqrXBzOr3ACHmr06-RbXf6iOjD4mxGHL250yp1Ntw==\" 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 \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccould,\u201d \u201cestablish,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cgoal,\u201d \u201cintend,\u201d \u201clook forward to,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould\u201d and similar expressions and the negatives of those terms. Forward-looking statements are based on management\u2019s 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\u00a0<\/em><br \/>\n        <em>plans<\/em><br \/>\n        <em> to have a Type A meeting with the FDA and work toward a timely resolution regarding an accelerated approval pathway for AMT-130; AMT-130 as a potentially disease-modifying therapy; and the Company\u2019s plans to provide a regulatory update after receipt of official meeting minutes from the scheduled Type A meeting. 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 \u201cRisk Factors\u201d 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, 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%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:50%;width:50%;min-width:50%\">\n            <strong>uniQure Contacts:<\/p>\n<p><\/strong><br \/>\n            <strong>FOR INVESTORS:<\/strong><\/p>\n<p>            <strong>Chiara Russo<\/strong><br \/>\n            <br \/>Direct: 781-491-4371<br \/>Mobile: 617-306-9137<br \/><a href=\"mailto:c.russo@uniQure.com\" rel=\"nofollow\" target=\"_blank\">c.russo@uniQure.com<\/a><\/td>\n<td style=\"max-width:50%;width:50%;min-width:50%\">\n            <strong><\/p>\n<p>FOR MEDIA:<\/p>\n<p>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=OTYyMjUyNyM3MzUyMTMwIzIwODA0MDY=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/OWZlNzFlMmQtN2YxMC00YmI4LWE2MjItZjliOGQ3YzY2OGY3LTEwOTE5NzctMjAyNi0wMS0wOS1lbg==\/tiny\/uniQure-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>LEXINGTON, Mass. and AMSTERDAM, Jan. 09, 2026 (GLOBE NEWSWIRE) &#8212; uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Biologics License Application (BLA) data package to support accelerated approval of AMT-130, the Company\u2019s investigational gene therapy for the treatment of Huntington\u2019s disease. \u201cWe look forward to a constructive discussion with the FDA as we work toward a timely resolution regarding an accelerated approval pathway for AMT-130,\u201d said Matt Kapusta, chief executive officer at uniQure. \u201cThe Huntington\u2019s disease community, including patients and clinicians, has emphasized the profound unmet medical need and the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;uniQure Announces Type A Meeting Scheduled with FDA&#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-925789","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>uniQure Announces Type A Meeting Scheduled with FDA - 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-announces-type-a-meeting-scheduled-with-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"uniQure Announces Type A Meeting Scheduled with FDA - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"LEXINGTON, Mass. and AMSTERDAM, Jan. 09, 2026 (GLOBE NEWSWIRE) &#8212; uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Biologics License Application (BLA) data package to support accelerated approval of AMT-130, the Company\u2019s investigational gene therapy for the treatment of Huntington\u2019s disease. \u201cWe look forward to a constructive discussion with the FDA as we work toward a timely resolution regarding an accelerated approval pathway for AMT-130,\u201d said Matt Kapusta, chief executive officer at uniQure. \u201cThe Huntington\u2019s disease community, including patients and clinicians, has emphasized the profound unmet medical need and the &hellip; Continue reading &quot;uniQure Announces Type A Meeting Scheduled with FDA&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-01-09T12:58:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYyMjUyNyM3MzUyMTMwIzIwODA0MDY=\" \/>\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-announces-type-a-meeting-scheduled-with-fda\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-announces-type-a-meeting-scheduled-with-fda\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"uniQure Announces Type A Meeting Scheduled with FDA\",\"datePublished\":\"2026-01-09T12:58:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-announces-type-a-meeting-scheduled-with-fda\\\/\"},\"wordCount\":833,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-announces-type-a-meeting-scheduled-with-fda\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTYyMjUyNyM3MzUyMTMwIzIwODA0MDY=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-announces-type-a-meeting-scheduled-with-fda\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uniqure-announces-type-a-meeting-scheduled-with-fda\\\/\",\"name\":\"uniQure Announces Type A Meeting Scheduled with FDA - 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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-announces-type-a-meeting-scheduled-with-fda\/","og_locale":"en_US","og_type":"article","og_title":"uniQure Announces Type A Meeting Scheduled with FDA - Market Newsdesk","og_description":"LEXINGTON, Mass. and AMSTERDAM, Jan. 09, 2026 (GLOBE NEWSWIRE) &#8212; uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Biologics License Application (BLA) data package to support accelerated approval of AMT-130, the Company\u2019s investigational gene therapy for the treatment of Huntington\u2019s disease. \u201cWe look forward to a constructive discussion with the FDA as we work toward a timely resolution regarding an accelerated approval pathway for AMT-130,\u201d said Matt Kapusta, chief executive officer at uniQure. \u201cThe Huntington\u2019s disease community, including patients and clinicians, has emphasized the profound unmet medical need and the &hellip; Continue reading \"uniQure Announces Type A Meeting Scheduled with FDA\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/","og_site_name":"Market Newsdesk","article_published_time":"2026-01-09T12:58:00+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYyMjUyNyM3MzUyMTMwIzIwODA0MDY=","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-announces-type-a-meeting-scheduled-with-fda\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"uniQure Announces Type A Meeting Scheduled with FDA","datePublished":"2026-01-09T12:58:00+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/"},"wordCount":833,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYyMjUyNyM3MzUyMTMwIzIwODA0MDY=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-announces-type-a-meeting-scheduled-with-fda\/","name":"uniQure Announces Type A Meeting Scheduled with FDA - 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