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UNIQURE N.V. (QURE)

(10% Negative) UNIQURE N.V. (QURE) Announces Delay in Application Development Timeline Due to Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Sept. 2, 2026, 11:06 a.m.

    📋 UNIQURE N.V. (QURE) - Clinical Trial Update

    Filing Date: 2026-09-02

    Accepted: 2026-09-02 07:06:12

    Event Type: Clinical Trial Update

    Event Details:

    UNIQURE N.V. (QURE) Announces Clinical Trial Update UNIQURE N.V. (QURE) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: Application, milestone
    • Clinical Stage: Phase I
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Regulatory Process, Regulatory Timeline
    • Collaboration: a Biologics License Application
      • anticipated in these forward-looking statements for many reasons. These risks and uncertainties include, among others: risks related to the Company’s Phase I/II clinical trials of ifezuntirgene inilparvovec, including the risk that such trials will be unable to continue to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that regulatory authorities, including the FDA and MHRA, ultimately conclude that the Phase I/II trial data are not sufficient to support regulatory approval, including accelerated approval with respect to a BLA; the risk that additional patient data leads to a different 1 Yohrling G, et al. Neurology 2020

    🔬 Clinical Development Pipeline (UNIQURE N.V.):

    Product Type Development Stage Therapeutic Area Source
    AAV9-hSyn1-miGRIK2 Other Phase PHASE1 Mesial Temporal Lobe Epilepsy ClinicalTrials.gov
    rAAV2/5-PBGD vector dosage 4 Other Phase PHASE1 Acute Intermittent Porphyria ClinicalTrials.gov
    rAAV2/5-PBGD vector dosage 3 Other Phase PHASE1 Acute Intermittent Porphyria ClinicalTrials.gov
    rAAV2/5-PBGD vector dosage 2 Other Phase PHASE1 Acute Intermittent Porphyria ClinicalTrials.gov
    rAAV2/5-PBGD vector dosage 1 Other Phase PHASE1 Acute Intermittent Porphyria ClinicalTrials.gov
    Mycophenolate mofetil Other Phase PHASE2 LPL Deficiency ClinicalTrials.gov
    Cyclosporins Other Phase PHASE2 LPL Deficiency ClinicalTrials.gov
    Prednisolone Other Phase PHASE2 LPL Deficiency ClinicalTrials.gov
    alipogene tiparvovec Other Phase PHASE2 LPL Deficiency ClinicalTrials.gov
    rAAV2/5-hNAGLU Other Phase PHASE1 Sanfilippo Syndrome B ClinicalTrials.gov
    Qualitative interview Other Preclinical Hemophilia ClinicalTrials.gov
    Observational study Other Preclinical Lipoprotein Lipase Deficiency ClinicalTrials.gov
    intra-striatal rAAV5-miHTT Other Phase PHASE1 Huntington Disease ClinicalTrials.gov
    Imitation (sham) surgery Procedure Phase PHASE1 Huntington's Disease ClinicalTrials.gov
    AMT-162 Other Phase PHASE1 Amyotrophic Lateral Sclerosis ClinicalTrials.gov
    AMT-191 Other Phase PHASE1 Fabry Disease ClinicalTrials.gov

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: UNIQURE N.V.
    • Ticker Symbol: QURE

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