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© Globe Newswire
04.12.2025
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uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
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LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License...
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© BusinessWire
12.11.2025
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uniQURE N.V. Investigation: Investors Encouraged to Contact Kirby McInerney LLP
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The law firm of Kirby McInerney LLP reminds investors its investigation on behalf of uniQURE N.V. (“uniQURE” or the “Company”) (NASDAQ:QURE) investors concerning the Company’s and/or members of its senior management’s possible violation of the federal securities laws or other unlawful business practices.
[LEARN MORE ABOUT THE INVESTIGATION]
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© Globe Newswire
10.11.2025
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uniQure Announces Third Quarter 2025 Financial Results and Provides Corporate Update
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~ Announced pivotal topline data from Phase I/II study of AMT-130 in Huntington’s disease met its primary and key secondary endpoints, demonstrating statistically significant slowing of disease progression at 36 months and supportive trends across key clinical and biomarker endpoints ~...
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20.10.2025
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© Globe Newswire
06.11.2025
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uniQure to Announce Third Quarter 2025 Financial Results
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~ uniQure to host earnings call on Monday, November 10, 2025 at 8:30 a.m. ET ~ ~ uniQure to host earnings call on Monday, November 10, 2025 at 8:30 a.m. ET ~...
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20.10.2025
© BusinessWire
04.11.2025
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NASDAQ: QURE Investigation Alert: Kessler Topaz Meltzer & Check, LLP Encourages uniQure N.V. (NASDAQ: QURE) Investors with Significant Losses to Contact the Firm
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The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) is currently investigating potential violations of the federal securities laws on behalf of investors of uniQure N.V. (NASDAQ: QURE) (“uniQure”).
On November 3, 2025, uniQure issued a press release revealing that the FDA notified the company that data for its AMT-130, an invest...
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© BusinessWire
03.11.2025
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QURE Investors Have Opportunity to Join uniQure N.V. Fraud Investigation with the Schall Law Firm
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The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of uniQure N.V. (“uniQure” or “the Company”) (NASDAQ: QURE) for violations of the securities laws.
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclos...
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© BusinessWire
03.11.2025
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uniQure N.V. Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights – QURE
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The DJS Law Group announces that it is investigating claims on behalf of investors of uniQure N.V. (“uniQure” or “the Company”) (NASDAQ: QURE) for violations of the securities laws.
INVESTIGATION DETAILS: The investigation focuses on whether the Company issued misleading statements and/or failed to disclose information pertinent to investors. On...
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© Globe Newswire
03.11.2025
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uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
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LEXINGTON, Mass. and AMSTERDAM, Nov. 03, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it received feedback from the U.S. Food and Drug Administration (FDA) during a recent pre-Biologics License Application (BLA)...
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© Globe Newswire
29.09.2025
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uniQure Announces Closing of Upsized Public Offering and Full Exercise by Underwriters of Option to Purchase Additional Shares
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LEXINGTON, Mass. and AMSTERDAM, Sept. 29, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the closing of its previously announced underwritten public offering of 6,736,841 ordinary shares at a public offering price of $4...
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© Globe Newswire
26.09.2025
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uniQure Announces Pricing of Upsized $300 Million Public Offering
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LEXINGTON, Mass. and AMSTERDAM, Sept. 25, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the pricing of its previously announced underwritten public offering of 5,789,473 ordinary shares at a public offering price of $4...
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© Globe Newswire
24.09.2025
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uniQure Announces $200 Million Proposed Public Offering
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LEXINGTON, Mass. and AMSTERDAM, Sept. 24, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it has commenced a $200 million underwritten public offering of its ordinary shares and, in lieu of ordinary shares to certai...
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© Globe Newswire
24.09.2025
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uniQure Announces Refinancing of Existing $50 Million Debt and Securing Up to an Additional $125 Million in Non-Dilutive Funding
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~ Term of current $50 million debt outstanding extended from January 2027 to October 2030 ~...
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20.10.2025
© Globe Newswire
24.09.2025
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uniQure Announces Positive Topline Results from Pivotal Phase I/II Study of AMT-130 in Patients with Huntington’s Disease
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~ Pivotal study met primary endpoint; high-dose AMT-130 demonstrated statistically significant 75% disease slowing at 36 months as measured by cUHDRS compared to a propensity score-matched external control ~...
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© Globe Newswire
05.09.2025
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uniQure Announces Initial AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry Disease
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~ All patients in the first cohort achieved between 27- to 208-fold increases in α-Gal A activity relative to mean normal level ~...
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© Globe Newswire
29.07.2025
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uniQure Announces Second Quarter 2025 Financial Results and Highlights of Recent Company Progress
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~ Achieved alignment with the FDA on the AMT-130 statistical analysis plan and CMC requirements to support a planned BLA submission in the first quarter of 2026;...
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© Globe Newswire
22.07.2025
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uniQure to Announce Second Quarter 2025 Financial Results
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uniQure to host earnings call on Tuesday, July 29, 2025 at 8:30 a.m. ET uniQure to host earnings call on Tuesday, July 29, 2025 at 8:30 a.m. ET...
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© Globe Newswire
11.06.2025
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uniQure Announces Appointment of Kylie O’Keefe as Chief Customer and Strategy Officer
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~ Proven biotech executive to lead commercialization of AMT-130 in Huntington’s disease ~...
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© Globe Newswire
02.06.2025
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uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
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~ Alignment with FDA continues to support Accelerated Approval pathway ~...
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© Globe Newswire
29.05.2025
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uniQure Presents Clinical Case Study of First Patient Dosed with AMT-260 in Refractory Mesial Temporal Lobe Epilepsy (MTLE)
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~ No serious adverse events and 92% reduction in seizure frequency observed in the first trial participant through first five months of follow up ~...
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© Globe Newswire
09.05.2025
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uniQure Announces First Quarter 2025 Financial Results and Highlights of Recent Company Progress
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~ AMT-130 granted Breakthrough Therapy designation by FDA ~...
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© Globe Newswire
17.04.2025
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uniQure Announces FDA Breakthrough Therapy Designation Granted to AMT-130 for the Treatment of Huntington’s Disease
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~ Breakthrough Therapy designation based on clinical evidence from Phase I/II trials showing meaningful slowing of disease progression ~...
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© Globe Newswire
27.02.2025
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uniQure Announces 2024 Financial Results and Highlights Recent Company Progress
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~ Announced alignment with the U.S. Food and Drug Administration (FDA) on key elements of the Accelerated Approval pathway for AMT-130 in Huntington’s disease; Initiated preparations for a potential Biologics License Application (BLA) submission ~...
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© Globe Newswire
03.02.2025
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uniQure Announces Completion of Enrollment in the First Cohort and Favorable Recommendation from the Independent Data Monitoring Committee for its Phase I/IIa Clinical Trial of AMT-191 for the Treatment of Fabry Disease
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~ Independent Data Monitoring Committee recommends proceeding with dosing of second cohort after planned safety assessment ~...
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© Globe Newswire
08.01.2025
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uniQure Announces Pricing of its Public Offering
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LEXINGTON, Mass. and AMSTERDAM, Jan. 08, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the pricing of its underwritten public offering of 4,411,764 of its ordinary shares at a public offering price of $17.00 per share....
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© Globe Newswire
07.01.2025
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uniQure Announces Proposed Public Offering
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LEXINGTON, Mass. and AMSTERDAM, Jan. 07, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it has commenced an underwritten public offering of its ordinary shares and pre-funded warrants to purchase its ordinary share...
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© Globe Newswire
10.12.2024
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uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
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~ 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 Application (BLA) for Accelerated Approval ~...
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© Globe Newswire
21.11.2024
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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
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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 needs, today announced that the first patient has been dosed in the GenTLE Phase I/IIa clinical trial of AMT-260 for the treatment of refractory mesial te...
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© Globe Newswire
05.11.2024
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uniQure Announces Third Quarter 2024 Financial Results and Highlights Recent Company Progress
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~ 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 ~...
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© Globe Newswire
15.10.2024
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uniQure Announces Dosing of First Patient in Phase I/II Clinical Trial of AMT-162 for the Treatment SOD1-ALS
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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 needs, today announced that the first patient has been dosed in the Phase I/II clinical trial of AMT-162 for the treatment of amyotrophic lateral sclerosi...
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© Globe Newswire
23.09.2024
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uniQure Announces Orphan Drug Designation Granted to AMT-191 for the Treatment of Fabry Disease
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LEXINGTON, Mass. and AMSTERDAM, Sept. 23, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AMT-191, uniQure’s investigational gene th...
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© Globe Newswire
15.08.2024
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uniQure Announces Dosing of First Patient in Phase I/IIa Clinical Trial of AMT-191 for the Treatment of Fabry Disease
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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 needs, today announced that the first patient has been dosed in a Phase I/IIa clinical trial of AMT-191 for the treatment of Fabry disease, a rare, inheri...
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© Globe Newswire
01.08.2024
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uniQure Announces Second Quarter 2024 Financial Results and Provides Company Update
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~ 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 neurodegeneration; Meeting with FDA expected in the second half of 2024 to discuss potential for expedited clinical development ~...
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© Globe Newswire
23.07.2024
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uniQure Announces Closing of Sale of Manufacturing Facility to Genezen
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~ uniQure maintains preferential access to industry-leading manufacturing capabilities to support its pipeline of gene therapy candidates ~...
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© Globe Newswire
09.07.2024
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uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase I/II Trials of AMT-130 for Huntington’s Disease
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~ 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 composite Unified Huntington’s Disease Rating Scale (cUHDRS) at 24 months compared to a propensity score-weighted external control ~...
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© Globe Newswire
01.07.2024
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uniQure Announces Sale of Commercial Manufacturing Facility to Genezen
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~ Proposed divestiture streamlines uniQure’s focus and represents an important milestone in its ongoing effort to significantly reduce operating expenses ~...
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© Globe Newswire
03.06.2024
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uniQure Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Investigational Gene Therapy AMT-130 in Huntington’s Disease
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~ Designation based on 24-month interim Phase I/II clinical data for AMT-130 announced in December 2023 ~...
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© Globe Newswire
07.05.2024
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uniQure Announces First Quarter 2024 Financial Results and Highlights Recent Company Progress
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uniQure announces first quarter 2024 results...
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