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Mental health, illness ,brain development ,medical treatment concept, messy lines of thinks in human head , vector illustration

UniQure Clears Path to Accelerated Approval for Huntington’s Gene Therapy

In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified Huntington’s Disease Rating Scale, and neurofilament light chain levels to support the accelerated approval of its gene therapy AMT-130.

December 10, 2024

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2 min read

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Tristan Manalac

Press Releases

uniQure Announces Proposed Public Offering

January 8, 2025

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4 min read

Press Releases

uniQure Announces Pricing of its Public Offering

January 9, 2025

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4 min read

uniQure Announces Sale of Commercial Manufacturing Facility to Genezen

uniQure N.V. announced that it has entered into an agreement for the sale of its global manufacturing facility in Lexington, Massachusetts to Genezen, a leading contract development and manufacturing organization specializing in the supply of retroviral vectors, lentiviral vectors, and adeno-associated virus technologies.

July 1, 2024

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7 min read

Genezen to Acquire uniQure’s Commercial Gene Therapy Manufacturing Operations in Lexington, MA

Genezen, a best-in-class gene therapy CDMO, announced an agreement to acquire uniQure’s commercial gene therapy operations in Lexington, MA, bringing a strategic manufacturing facility and a world-class team of employees to the company.

July 1, 2024

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3 min read

Pictured: uniQure headquarters in Amsterdam

Huntington’s Disease

UniQure Wins First FDA RMAT in Huntington’s Disease After Strong Phase I/II Data

Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease.

July 9, 2024

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2 min read

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Tristan Manalac

Press Releases

uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease

December 11, 2024

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9 min read

Press Releases

uniQure Announces Favorable Recommendation from Independent Data Monitoring Committee for its Phase I/II EPISOD1 Clinical Trial of AMT-162 for the Treatment of SOD1-ALS