Phase I/II study can serve as the primary basis of a Biologics License Application for accelerated approval with FDA ...
Announced alignment with the U.S. FDA on key elements of the Accelerated Approval pathway for AMT-130 in Huntington’s disease, moving closer to the potential approval of a disease-modifying treatment.
"Key milestones include our Type B FDA meeting later in the second quarter, clinical update for AMT-260 in the second quarter, 4-year AMT-130 data analysis in the third quarter and the planned MAA ...
uniQure recently divested from its Lexington facility to Genezen and freed $25 million while significantly reducing its operating costs. At the same time, AMT-130 has received the FDA’s Breakthrough ...
LEXINGTON, Mass. and AMSTERDAM, Nov. 03, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, ...
Management reiterated the expectation for top line pivotal data from AMT-130 and initial Fabry data in September, with a planned BLA submission for AMT-130 in the first quarter of 2026. The team ...
UniQure NV (NASDAQ:QURE) is one of the 10 Stocks Making Investors Richer. UniQure skyrocketed by 78.44 percent on Wednesday to finish at $48.16 apiece as investors gobbled up shares after the Food and ...
Qure is back in focus after modelled fair value estimates shifted from about US$39.05 to roughly US$52.56, a change that has fed directly into higher price targets across some recent research.
Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. uniQure (NasdaqGS:QURE) reports favorable regulatory ...
Shares of uniQure QURE soared 78.4% on June 17, after the company announced a major regulatory milestone for AMT-130, its investigational gene therapy for Huntington's disease. The stock, however, ...
~ Pivotal study met primary endpoint; high-dose AMT-130 demonstrated statistically significant 75% disease slowing at 36 months as measured by cUHDRS compared to a propensity score-matched external ...
LEXINGTON, Mass. and AMSTERDAM, June 02, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, ...