{"id":940993,"date":"2026-03-02T07:59:59","date_gmt":"2026-03-02T12:59:59","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-3\/"},"modified":"2026-03-02T07:59:59","modified_gmt":"2026-03-02T12:59:59","slug":"uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-3","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/uniqure-provides-regulatory-update-on-amt-130-for-huntingtons-disease-3\/","title":{"rendered":"uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease"},"content":{"rendered":"
\n

LEXINGTON, Mass. and AMSTERDAM, March 02, 2026 (GLOBE NEWSWIRE) — 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 Type A meeting held on January 30, 2026 to discuss AMT-130, an investigational gene therapy for Huntington\u2019s disease (HD). \u00a0<\/p>\n

The FDA stated that it cannot agree that data from the Phase I\/II studies, compared to an external control, are sufficient to provide the primary evidence of effectiveness required to support a marketing application for AMT-130. The FDA strongly recommended uniQure conduct a prospective, randomized, double-blind, sham surgery-controlled study. uniQure intends to continue engaging with the FDA regarding Phase III development considerations and plans to request a Type B meeting in the second quarter of 2026 to further discuss potential study design approaches.<\/p>\n

\u201cWhile we did not reach alignment on a submission pathway based on the Phase I\/II data, we believe the totality and durability of our data warrant continued substantive dialogue regarding how the FDA\u2019s stated commitment to regulatory flexibility may be appropriately applied in this setting,\u201d said Matt Kapusta, chief executive officer at uniQure<\/a>. \u201cWe remain committed to engaging with the FDA to determine a clear, scientifically grounded, and efficient path forward for AMT-130. We are deeply grateful for the resilience and support of the Huntington\u2019s disease community and remain committed to standing with patients and their families as we advance this potentially transformative therapy for a community in need.\u201d<\/p>\n

\n About uniQure <\/strong>\n <\/p>\n

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 pipeline<\/a> of proprietary gene therapies for the treatment of patients with Huntington’s disease, refractory temporal lobe epilepsy, ALS, Fabry disease, and other severe diseases.\u00a0www.uniQure.com<\/a><\/p>\n

\n uniQure Forward-Looking Statements<\/strong>\n <\/p>\n

\n 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 “anticipate,” “believe,” “could,” \u201cestablish,\u201d “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” \u201cseek,\u201d “should,” “will,” “would” and similar expressions and the negatives of those terms. Forward-looking statements are based on management’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: plans to continue engaging with the FDA regarding Phase III development considerations for AMT-130; <\/em>
\n plans <\/em>
\n to request a Type B meeting with the FDA to take place in the second quarter of 2026<\/em>
\n ;<\/em>
\n and the potential benefit of AMT-130. 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>
\n 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; the risk that we will be unable to align with the FDA or other regulatory authorities on an approval pathway for our gene therapy candidates, including AMT-130; 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; 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 “Risk Factors” in the Company\u2019s periodic\u00a0filings with the U.S. Securities & Exchange Commission (SEC), including its Annual Reports on Form 10-K , its Quarterly Reports on Form 10-Q 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

\n uniQure Contacts:<\/strong>\n <\/p>\n\n\n
\n FOR INVESTORS:\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/strong><\/p>\n

Chiara Russo<\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
Direct: 781-491-4371\u00a0\u00a0\u00a0\u00a0
Mobile: 617-306-9137\u00a0\u00a0\u00a0
c.russo@uniQure.com<\/a>\u00a0\u00a0 <\/td>\n

\n FOR MEDIA:<\/strong><\/p>\n

Tom Malone<\/strong>
\n
Direct: 339-970-7558
Mobile:339-223-8541\u00a0\u00a0\u00a0\u00a0
t.malone@uniQure.com<\/a><\/td>\n<\/tr>\n<\/table>\n

\n
\n
\n <\/strong>\n <\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

LEXINGTON, Mass. and AMSTERDAM, March 02, 2026 (GLOBE NEWSWIRE) — 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 Type A meeting held on January 30, 2026 to discuss AMT-130, an investigational gene therapy for Huntington\u2019s disease (HD). \u00a0 The FDA stated that it cannot agree that data from the Phase I\/II studies, compared to an external control, are sufficient to provide the primary evidence of effectiveness required to support a marketing application for AMT-130. The FDA strongly recommended uniQure conduct a prospective, randomized, double-blind, sham surgery-controlled study. uniQure intends to continue … <\/p>\n

Continue reading “uniQure Provides Regulatory Update on AMT-130 for Huntington\u2019s Disease”<\/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-940993","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nuniQure 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-3\/\" \/>\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, March 02, 2026 (GLOBE NEWSWIRE) — uniQure N.V. 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