reports
uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) -- 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 Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntington’s disease (HD). In the final meeting minu...
Uniqure Nv: 1 director
A director at Uniqure Nv sold/sold after exercising options 31,434 shares at 27.260USD and the significance rating of the trade was 62/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over t...
uniQure Announces Third Quarter 2025 Financial Results and Provides Co...
uniQure Announces Third Quarter 2025 Financial Results and Provides Corporate Update ~ 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 ~ ~ Preliminary feedback from FDA at a recent pre-Biologics License Application (BLA) meeting for AMT-130 indicated a key shift from prior regulatory communications; uniQure plans to urgently interact with the FDA to define ne...
uniQure to Announce Third Quarter 2025 Financial Results
uniQure to Announce Third Quarter 2025 Financial Results ~ uniQure to host earnings call on Monday, November 10, 2025 at 8:30 a.m. ET ~ LEXINGTON, Mass. and AMSTERDAM, Nov. 06, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs will report third quarter 2025 financial results before market open on Monday, November 10, 2025. Management will then host a conference call at 8:30 a.m. ET. The event will be webcast under the Events & Presentations section of uniQure’s website at , and followi...
uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease LEXINGTON, Mass. and AMSTERDAM, Nov. 03, 2025 (GLOBE NEWSWIRE) -- 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) meeting regarding AMT-130, an investigational gene therapy for Huntington’s disease (HD). Though final meeting minutes have not yet been received, based on the discussions at the m...
uniQure Announces Closing of Upsized Public Offering and Full Exercise...
uniQure Announces Closing of Upsized Public Offering and Full Exercise by Underwriters of Option to Purchase Additional Shares 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 $47.50 per share, which includes 947,368 ordinary shares issued pursuant to the exercise in full by the underwriters of th...
uniQure Announces Pricing of Upsized $300 Million Public Offering
uniQure Announces Pricing of Upsized $300 Million Public Offering 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 $47.50 per share, and, in lieu of ordinary shares to certain investors, pre-funded warrants to purchase 526,316 of its ordinary shares at the public offering price per share less the ...
uniQure Announces $200 Million Proposed Public Offering
uniQure Announces $200 Million Proposed Public Offering 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 certain investors, pre-funded warrants to purchase its ordinary shares. All securities to be sold in the offering will be offered by uniQure. In addition, uniQure intends to grant the underwriters ...
uniQure Announces Refinancing of Existing $50 Million Debt and Securin...
uniQure Announces Refinancing of Existing $50 Million Debt and Securing Up to an Additional $125 Million in Non-Dilutive Funding ~ Term of current $50 million debt outstanding extended from January 2027 to October 2030 ~ ~ Additional $100 million available subject to regulatory and financial milestones ~ ~ Additional $25 million available subject to Hercules’ approval ~ ~ Transaction provides financial flexibility and improves cost of capital ~ LEXINGTON, Mass. and AMSTERDAM, Sept. 24, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing trans...
uniQure Announces Positive Topline Results from Pivotal Phase I/II Stu...
uniQure Announces Positive Topline Results from Pivotal Phase I/II Study of AMT-130 in Patients with Huntington’s Disease ~ 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 ~ ~ High-dose AMT-130 also demonstrated statistically significant slowing of disease progression as measured by TFC, a key secondary endpoint, and favorable trends across additional clinical measures ~ ~ Mean cerebrospinal fluid NfL levels were below baseline at 36 m...
uniQure Announces Initial AMT-191 Phase I/IIa Data Showing Sustained I...
uniQure Announces Initial AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry Disease ~ All patients in the first cohort achieved between 27- to 208-fold increases in α-Gal A activity relative to mean normal level ~ ~ All patients in first cohort discontinued enzyme replacement therapy ~ ~ Preliminary data show AMT-191 has a manageable safety profile at the highest dose ~ ~ Updated clinical results expected in the first half of 2026 ~ LEXINGTON, Mass. and AMSTERDAM, Sept. 05, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading ge...
uniQure Announces Second Quarter 2025 Financial Results and Highlights...
uniQure Announces Second Quarter 2025 Financial Results and Highlights of Recent Company Progress ~ 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; ~ Company expects to present AMT-130 topline three-year data in September 2025 ~ ~ Presented case study from first participant treated with AMT-260 for refractory mesial temporal lobe epilepsy showing 92% seizure reduction with no serious adverse events through first five months of follow u...
uniQure to Announce Second Quarter 2025 Financial Results
uniQure to Announce Second Quarter 2025 Financial Results uniQure to host earnings call on Tuesday, July 29, 2025 at 8:30 a.m. ET LEXINGTON, Mass. and AMSTERDAM, July 22, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs will report second quarter 2025 financial results before market open on Tuesday, July 29, 2025. Management will then host a conference call at 8:30 a.m. ET. The event will be webcast under the Events & Presentations section of uniQure’s website at , and following th...
uniQure Announces Appointment of Kylie O’Keefe as Chief Customer and ...
uniQure Announces Appointment of Kylie O’Keefe as Chief Customer and Strategy Officer ~ Proven biotech executive to lead commercialization of AMT-130 in Huntington’s disease ~ LEXINGTON, Mass. and AMSTERDAM, June 11, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the appointment of Kylie O’Keefe as Chief Customer and Strategy Officer, effective June 6, 2025. In this role, Ms. O’Keefe will lead the development and execution of uniQure’s global commercialization strate...
uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease ~ Alignment with FDA continues to support Accelerated Approval pathway ~ ~ BLA submission planned for first quarter of 2026 ~ ~ Conference call today at 8:30 a.m. ET ~ LEXINGTON, Mass. and AMSTERDAM, June 02, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today provided a regulatory update on AMT-130, its investigational gene therapy for the treatment of Huntington’s disease. Following recent Type B meetings and...
uniQure Presents Clinical Case Study of First Patient Dosed with AMT-2...
uniQure Presents Clinical Case Study of First Patient Dosed with AMT-260 in Refractory Mesial Temporal Lobe Epilepsy (MTLE) ~ No serious adverse events and 92% reduction in seizure frequency observed in the first trial participant through first five months of follow up ~ ~ Data to be presented today at Epilepsy Therapies & Diagnostics Development Symposium (ETDD) ~ LEXINGTON, Mass. and AMSTERDAM, May 29, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the presenta...
uniQure Announces First Quarter 2025 Financial Results and Highlights ...
uniQure Announces First Quarter 2025 Financial Results and Highlights of Recent Company Progress ~ AMT-130 granted Breakthrough Therapy designation by FDA ~ ~ Initial safety data from third cohort of Phase I/II study show AMT-130 continues to be generally well-tolerated, with no treatment-related serious adverse events ~ ~ Held Type B FDA meetings in the first and second quarters of 2025 to advance BLA preparations for AMT-130; regulatory update expected in the second quarter of 2025 ~ ~ AMT-260 clinical data from first patient to be presented at Epilepsy Therapies & Diagnostics De...
uniQure to Announce First Quarter 2025 Financial Results
uniQure to Announce First Quarter 2025 Financial Results ~ uniQure to host inaugural earnings call on Friday, May 9, 2025 at 8:30 a.m. ET ~ LEXINGTON, Mass. and AMSTERDAM, the Netherlands, May 05, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs will report first quarter 2025 financial results before market open on Friday, May 9, 2025. Management will then host a conference call at 8:30 a.m. ET. As the Company advances its pipeline and AMT-130 toward a BLA submission and potential comm...
uniQure Announces FDA Breakthrough Therapy Designation Granted to AMT-...
uniQure Announces FDA Breakthrough Therapy Designation Granted to AMT-130 for the Treatment of Huntington’s Disease ~ Breakthrough Therapy designation based on clinical evidence from Phase I/II trials showing meaningful slowing of disease progression ~ ~ Additional regulatory update and guidance on the Biologics License Application submission expected in the second quarter of 2025 ~ LEXINGTON, Mass. and AMSTERDAM, April 17, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today ann...
uniQure Announces 2024 Financial Results and Highlights Recent Compan...
uniQure Announces 2024 Financial Results and Highlights Recent Company Progress ~ 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 ~ ~ Completed patient enrollment in the third cohort of the Phase I/II study of AMT-130 ~ ~ Initiated dosing of the Phase I/II study of AMT-260 in mesial temporal lobe epilepsy (mTLE); Implementing protocol changes to expand study inclusion...
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