Uniqure NV 8-K filings

uniQure reports strong Q2 2026 results with key regulatory milestones for AMT-130, a strengthened financial position extending cash runway to 2030, and positive early data for AMT-260.

uniQure N.V. has priced an upsized public offering of 4,945,055 ordinary shares at $45.50 per share, with underwriters fully exercising their option for additional shares.

uniQure announced its plan to submit a Biologics License Application (BLA) for its Huntington's disease gene therapy, AMT-130, in the third quarter of 2026, following FDA agreement on using 3-year Phase I/II data for accelerated approval.

uniQure N.V. shareholders approved amendments to the 2014 Share Incentive Plan and changes to the company's articles of association, including an exclusive forum selection clause.

uniQure reports Q1 2026 financial results, highlighting progress in its gene therapy pipeline, particularly for Huntington's disease, while navigating regulatory feedback from the FDA.

uniQure N.V. announced a successful pre-submission meeting with the UK MHRA for its Huntington's disease gene therapy, AMT-130, targeting a Q3 2026 Marketing Authorization Application submission.

uniQure announced its 2025 financial results and pipeline updates, including a significant regulatory setback for its Huntington's disease gene therapy, AMT-130, with the FDA requiring a Phase III study.

uniQure N.V. updated its corporate presentation, highlighting positive 36-month data for its Huntington's disease gene therapy, AMT-130, and progress across its robust clinical pipeline.

uniQure N.V. announced a Type A meeting with the FDA to discuss the Biologics License Application data package for accelerated approval of AMT-130, its investigational gene therapy for Huntington's disease.

uniQure announced that the FDA deemed Phase I/II data for its Huntington's disease gene therapy, AMT-130, currently insufficient for a Biologics License Application submission.

uniQure reported Q3 2025 financial results, positive AMT-130 Huntington's data, but faces unexpected FDA feedback delaying BLA submission.

uniQure N.V. announced that the FDA no longer considers its Phase I/II data for AMT-130 sufficient for a BLA submission, making the timing of approval unclear.

uniQure N.V. announced the pricing of an upsized public offering of ordinary shares and pre-funded warrants, expecting to raise approximately $323.75 million in net proceeds.

uniQure N.V. amended its loan agreement with Hercules Capital, securing up to $175 million to refinance existing debt and fund general corporate purposes, contingent on key clinical and financing milestones.

uniQure N.V. announced positive topline data from its pivotal Phase I/II study of AMT-130 for Huntington's disease, meeting primary and key secondary endpoints.

uniQure N.V. has entered into a sales agreement with Leerink Partners LLC to establish an at-the-market equity offering program, allowing the company to sell up to $200 million of its ordinary shares.

uniQure N.V. announced its second quarter 2025 financial results and significant progress in its gene therapy pipeline, including FDA alignment for a planned BLA submission for AMT-130 in Huntington's disease.

uniQure N.V. announced that its shareholders approved all 11 proposals at the 2025 Annual General Meeting, including the adoption of 2024 financial accounts, re-election of directors, and an amendment to the 2014 Share Incentive Plan to increase shares reserved for issuance.

uniQure N.V. announced alignment with the U.S. Food and Drug Administration on critical statistical analysis and manufacturing plans for its investigational Huntington's disease gene therapy, AMT-130, targeting a Biologics License Application submission in the first quarter of 2026.

uniQure reports Q1 2025 financial results, highlighting FDA Breakthrough Therapy designation for AMT-130 and advancements in its gene therapy pipeline.

uniQure N.V. has amended and restated the employment agreement with its CEO, Matthew Kapusta, outlining his compensation and severance terms.

uniQure reports 2024 financial results, highlights progress in Huntington's disease and other gene therapy programs, and anticipates funding operations into the second half of 2027.

uniQure N.V. has announced the pricing of a public offering of 4,411,764 ordinary shares at $17.00 per share, expected to generate approximately $75 million in gross proceeds.

uniQure has reached an agreement with the FDA on key elements for an accelerated approval pathway for its AMT-130 gene therapy for Huntington's disease.

uniQure has dosed the first patient in its Phase I/IIa clinical trial of AMT-260, a gene therapy for refractory mesial temporal lobe epilepsy.

uniQure reported its third quarter 2024 financial results, highlighting positive clinical data for its Huntington's disease treatment, AMT-130, and a strategic restructuring to reduce operating expenses.

uniQure has announced the dosing of the first patient in its Phase I/II clinical trial of AMT-162, a gene therapy for amyotrophic lateral sclerosis (ALS) caused by SOD1 mutations.

uniQure's investigational gene therapy, AMT-191, has been granted Orphan Drug Designation by the FDA for the treatment of Fabry disease.

uniQure has announced the dosing of the first patient in its Phase I/IIa clinical trial of AMT-191, a gene therapy for Fabry disease.

uniQure reports positive clinical trial data for its Huntington's disease treatment, initiates new studies, and announces a major restructuring to reduce costs and extend its cash runway.