QURE

#1659
uniQure N.V. - Ordinary Shares
46.2 3 USD
-0.03%
Market Price
Sektor: Gesundheitswesen
Basis: USD
Gewinnwährung: USD
Tagesspanne
46.23
46.23
Jahresspanne
8.73
71.50
Tagesänderung
-3.41%
Monatliche Änderung
+4.57%
6 month change
+409.14%
Jahresänderung
+165.38%
Vorheriger Schlusskurs
47.8 6
Open
46.2 3
Tief
46.2 3
Hoch
46.2 3
Volumen
94
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Financials

Übersicht Finanzbericht Statistik Documents

2026

Current report, Q3 FY2026
Uniqure N.V. current report, Q3 FY2026
8-K
Quarterly report, Q2 FY2026
Uniqure N.V. quarterly report, Q2 FY2026
10-Q
Current report, Q2 FY2026
Uniqure N.V. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Uniqure N.V. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Uniqure N.V. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Uniqure N.V. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Uniqure N.V. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Uniqure N.V. current report, Q2 FY2026
8-K
Quarterly report, Q1 FY2026
Uniqure N.V. quarterly report, Q1 FY2026
10-Q
Current report, Q1 FY2026
Uniqure N.V. current report, Q1 FY2026
8-K

Uniqure N.V. current report, Q2 FY2025

Full document

Business Context and Reporting Period

Company: uniQure N.V.
Filing Type: Form 8-K (Current Report)
Date of Report: June 2, 2025
Reporting Period: Single event date (June 2, 2025)
Business Context: The filing discloses a significant regulatory milestone regarding the Company's investigational gene therapy, AMT-130, intended for the treatment of Huntington's disease.

Key Financial Metrics

This Form 8-K is a current report regarding a specific corporate event and does not contain financial statements. Consequently, the filing text does not provide clear values for revenue, profit, cash flow, margins, debt, or liquidity metrics.

Material Changes

The primary material change reported is a regulatory alignment with the U.S. Food and Drug Administration (FDA). Specifically, the Company reached agreement on several key components of the statistical analysis plan and Chemistry, Manufacturing and Controls (CMC) information. This alignment is intended to support a future Biologics License Application (BLA) submission for AMT-130.

Guidance, Outlook, and Management Commentary

  • Regulatory Outlook: The alignment with the FDA represents a critical step toward the potential BLA submission for AMT-130.
  • Management Commentary: The Company announced an investor call and webcast held on June 2, 2025, at 8:30 a.m. Eastern Time to discuss these updates. The event was available for replay for 90 days.
  • Risks and Contingencies: The filing does not explicitly detail new risks or contingencies beyond the inherent uncertainties of the regulatory approval process implied by the BLA preparation.

Important Facts for Investor Verification

  • Confirmation of the specific components of the statistical analysis plan and CMC information agreed upon with the FDA.
  • The timeline and specific requirements for the upcoming Biologics License Application (BLA) submission for AMT-130.
  • Details provided during the June 2, 2025 investor call regarding the path to commercialization.
  • Any subsequent updates on the status of the BLA submission following this alignment.

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