QURE UNIQURE NV

uniQure Announces Enrollment of Next Two Patients in Phase I/II Clinical Trial of AMT-130 for the Treatment of Huntington’s Disease

uniQure Announces Enrollment of Next Two Patients in Phase I/II Clinical Trial of AMT-130 for the Treatment of Huntington’s Disease
EN
13/10/2020

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Reports on UNIQURE NV

 PRESS RELEASE

uniQure Announces 2025 Financial Results and Provides Recent Company U...

uniQure Announces 2025 Financial Results and Provides Recent Company Updates ~ Held Type A meeting with FDA to discuss AMT-130 for Huntington’s disease; Company evaluating Phase III development considerations and plans to request follow-up Type B meeting in the second quarter of 2026 ~ ~ Completed enrollment of the first cohort in the Phase I/IIa study of AMT-260 in refractory mesial temporal lobe epilepsy, with additional clinical data expected in the first half of 2026 ~ ~ Presented updated Phase I/II data from AMT-191 in Fabry disease showing durable, dose-dependent increases in α-Gal ...

 PRESS RELEASE

uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease

uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease LEXINGTON, Mass. and AMSTERDAM, March 02, 2026 (GLOBE NEWSWIRE) -- 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’s disease (HD).   The FDA stated that it cannot agree that data from the Phase I/II studies, com...

 PRESS RELEASE

uniQure to Announce 2025 Financial Results

uniQure to Announce 2025 Financial Results ~ uniQure to host earnings call on Monday, March 2, 2026 at 8:00 a.m. ET ~ LEXINGTON, Mass. and AMSTERDAM, Feb. 23, 2026 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs will report fourth quarter and full year of 2025 financial results before market open on Monday, March 2, 2026. Management will then host a conference call at 8:00 a.m. ET. The event will be webcast under the Events & Presentations section of uniQure’s website at , and following t...

 PRESS RELEASE

uniQure Announces Updated Preliminary AMT-191 Phase I/IIa Data Showing...

uniQure Announces Updated Preliminary AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry Disease ~ Supraphysiological expression of α-Gal A activity maintained for over a year in longest treated patient as of data cutoff date ~ ~ Stable Lyso-Gb3 levels maintained post-dosing, regardless of enzyme replacement therapy status across all cohorts ~ ~ Six of 11 patients have discontinued enzyme replacement therapy as of data cutoff date ~ LEXINGTON, Mass. and AMSTERDAM, Feb. 06, 2026 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene ...

 PRESS RELEASE

uniQure Announces Type A Meeting Scheduled with FDA

uniQure Announces Type A Meeting Scheduled with FDA LEXINGTON, Mass. and AMSTERDAM, Jan. 09, 2026 (GLOBE NEWSWIRE) -- 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’s investigational gene therapy for the treatment of Huntington’s disease. “We look forward to a constructive discussion with th...

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