uniQure’s AMT-130 Regulatory Progress Sharpens Huntington’s Disease Investment Case

Qure (NasdaqGS:QURE) reports favorable regulatory feedback in the UK and US on its gene therapy AMT-130 for Huntington’s ...
HDBuzz

A Second Path: uniQure Plans Regulatory Filing for AMT-130 in the UK

On April 30, 2026, uniQure announced that it held a Pre-Submission Meeting with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and plans to file a formal application ...

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 ...
Nasdaq

uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-191 Gene Therapy for Fabry Disease

LEXINGTON, Mass. and AMSTERDAM, Nov. 29, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, ...

UniQure plans U.K. AMT-130 MAA submission in Q3 as it expects cash runway into H2 2029

"Revenue for the 3 months ended March 31, 2026, was $3.6 million" and "cash, cash equivalents and investment securities totaled $586.6 million"; uniQure "expect [s] that cash, cash equivalents and ...