uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
December 10, 2024 07:05 ET
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uniQure Inc.
~ U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a Biologics License...
uniQure Announces Dosing of First Patient in GenTLE Phase I/IIa Clinical Trial of AMT-260 for the Treatment of Refractory Mesial Temporal Lobe Epilepsy
November 21, 2024 07:05 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, Nov. 21, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
uniQure Announces Third Quarter 2024 Financial Results and Highlights Recent Company Progress
November 05, 2024 07:05 ET
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uniQure Inc.
~ Type B meeting scheduled with the FDA in the fourth quarter of 2024 to initiate discussions regarding a potential expedited clinical development pathway for AMT-130 in Huntington’s disease ~ ~...
uniQure Announces Dosing of First Patient in Phase I/II Clinical Trial of AMT-162 for the Treatment of SOD1-ALS
October 15, 2024 07:05 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, Oct. 15, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
uniQure Announces Dosing of First Patient in Phase I/IIa Clinical Trial of AMT-191 for the Treatment of Fabry Disease
August 15, 2024 07:05 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, Aug. 15, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
uniQure Announces Second Quarter 2024 Financial Results and Provides Company Update
August 01, 2024 07:05 ET
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uniQure Inc.
~ Announced RMAT designation for AMT-130 in Huntington’s disease and positive interim Phase I/II data demonstrating the slowing of disease progression and reductions in a key biomarker of...
uniQure Announces Closing of Sale of Manufacturing Facility to Genezen
July 23, 2024 07:05 ET
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uniQure Inc.
~ uniQure maintains preferential access to industry-leading manufacturing capabilities to support its pipeline of gene therapy candidates ~ ~ Immediate reduction in cash burn, projected to save $40...
uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase I/II Trials of AMT-130 for Huntington’s Disease
July 09, 2024 07:05 ET
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uniQure Inc.
~ Achieved statistically significant, dose-dependent, and durable evidence of potential therapeutic benefit; Patients receiving high-dose AMT-130 showed 80% slowing of disease progression in the...
uniQure Announces Sale of Commercial Manufacturing Facility to Genezen
July 01, 2024 07:05 ET
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uniQure Inc.
~ Proposed divestiture streamlines uniQure’s focus and represents an important milestone in its ongoing effort to significantly reduce operating expenses ~ ~ Genezen to manufacture global...
uniQure Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Investigational Gene Therapy AMT-130 in Huntington’s Disease
June 03, 2024 07:05 ET
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uniQure Inc.
~ Designation based on 24-month interim Phase I/II clinical data for AMT-130 announced in December 2023 ~ ~ AMT-130 is the first therapeutic candidate to receive RMAT Designation for Huntington’s...