Business

uniQure Announces Successful UK MHRA Pre-Submission Meeting for AMT-130 in Huntington’s Disease

~ Submission of a UK Marketing Authorization Application for AMT-130 is expected in the third quarter of 2026 ~ ~ Type B Meeting with U.S. FDA granted in second quarter; expect to discuss potential Phase III design and analysis plan for AMT-130 four-year data ~ ~ uniQure actively pursuing additional ex-US regulatory pathways to support potential registration of AMT-130 in international markets ~ LEXINGTON, Mass. and AMSTERDAM, April 30, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a lea

articleUniqure N.v.April 30, 20263/company/uniqure-nv/news/uniqure-announces-successful-uk-mhra-pre-submission-meeting-for-amt-130-in-huntingtons-disease
uniQure Announces Successful UK MHRA Pre-Submission Meeting for AMT-130 in Huntington’s Disease

About this update from Uniqure N.v.

[{"type":"image","alt":"uniQure Inc.","displaySize":"","headline":null,"caption":"uniQure Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":96,"url":"https://media.zenfs.com/en/globenewswire.com/cb8da6eec71588a1000495a1c5d28a54"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/h5.5Z.Ho3JaFHspAcjq2vA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzNA--/https://media.zenfs.com/en/globenewswire.com/cb8da6eec71588a1000495a1c5d28a54","width":300,"height":96}},"lazy":false},{"type":"text","content":"~ Submission of a UK Marketing Authorization Application for AMT-130 is expected in the third quarter of 2026 ~","length":117,"tagName":"p"},{"type":"text","content":"~ Type B Meeting with U.S. FDA granted in second quarter; expect to discuss potential Phase III design and analysis plan for AMT-130 four-year data ~","length":149,"tagName":"p"},{"type":"text","content":"~ uniQure actively pursuing additional ex-US regulatory pathways to support potential registration of AMT-130 in international markets ~","length":137,"tagName":"p"},{"type":"text","content":"LEXINGTON, Mass. and AMSTERDAM, April 30, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the Company held a Pre-Submission Meeting with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and plans to submit a Marketing Authorization Application (MAA) for AMT-130 for the treatment of Huntington’s disease in the third quarter of 2026.","length":497,"tagName":"p"},{"type":"text","content":"“We are encouraged by the constructive feedback from the MHRA as we continue to work towards a regulatory submission for AMT-130 in Huntington’s disease, which we now expect to submit in the third quarter of this year,” said Matt Kapusta, chief executive officer of uniQure. “This is an important milestone for the Huntington’s disease community and we remain committed to working closely with regulators globally, with the goal of bringing this potentially transformative therapy to patients in the UK and internationally.”","length":524,"tagName":"p"},{"type":"text","content":"During the meeting, the Company and MHRA discussed the data package and manufacturing requirements to support a MAA submission for AMT-130. Following these discus...

More updates from Uniqure N.v.

Huntington’s diseaseMHRAThe CompanyuniQureMedicines and Healthcare products Regulatory Agencygene therapystatistical analysis planconstructive feedbackCompanyregulatory submission