reports
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...
uniQure Announces Completion of Enrollment in the First Cohort and Fav...
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 ~ Independent Data Monitoring Committee recommends proceeding with dosing of second cohort after planned safety assessment ~ ~ Company expects to initiate enrollment of second dose cohort in the first quarter of 2025 ~ LEXINGTON, Mass. and AMSTERDAM, Feb. 03, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative th...
uniQure Announces Favorable Recommendation from Independent Data Monit...
uniQure Announces Favorable Recommendation from Independent Data Monitoring Committee for its Phase I/II EPISOD1 Clinical Trial of AMT-162 for the Treatment of SOD1-ALS ~ Independent Data Monitoring Committee Recommends Proceeding with Dose Escalation After Planned Safety Assessment of First Dose Cohort ~ ~ Company Expects to Initiate Enrollment of Second Dose Cohort in the First Quarter of 2025 ~ LEXINGTON, Mass. and AMSTERDAM, Jan. 30, 2025 (GLOBE NEWSWIRE) -- N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs...
uniQure Announces Pricing of its Public Offering
uniQure Announces Pricing of its Public Offering 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. The aggregate gross proceeds to uniQure from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by uniQure, are expected to be approximately $75...
uniQure Announces Proposed Public Offering
uniQure Announces Proposed Public Offering 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 shares. All securities to be sold in the offering will be offered by uniQure. In addition, uniQure intends to grant the underwriters a 30-day option to purchase up to 15% additional ordinary shares at the publ...
uniQure Announces Alignment with FDA on Key Elements of Accelerated Ap...
uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease ~ 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 ~ ~ FDA agrees that the composite Unified Huntington’s Disease Rating Scale (cUHDRS) may serve as an intermediate clinical endpoint for Accelerated Approval ~ ~ Conference call today at 8:30 a.m. ET ~ LEXINGTON, Mass. and AMSTERD...
uniQure Announces Dosing of First Patient in GenTLE Phase I/IIa Clinic...
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 LEXINGTON, Mass. and AMSTERDAM, Nov. 21, 2024 (GLOBE NEWSWIRE) -- 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 temporal lobe epilepsy (). “The dosing of the first patient in our Phase I/II trial in temporal lobe ep...
uniQure Announces Third Quarter 2024 Financial Results and Highlights ...
uniQure Announces Third Quarter 2024 Financial Results and Highlights Recent Company Progress ~ 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 ~ ~ Presented positive interim data from Phase I/II trial of AMT-130 demonstrating slowing of Huntington’s disease progression and reductions in key biomarker of neurodegeneration ~ ~ Initiated patient dosing in new Phase I/II studies of AMT-162 in SOD1-ALS and AMT-191 in Fabry disease; First patient enrolled...
uniQure Announces Dosing of First Patient in Phase I/II Clinical Trial...
uniQure Announces Dosing of First Patient in Phase I/II Clinical Trial of AMT-162 for the Treatment SOD1-ALS LEXINGTON, Mass. and AMSTERDAM, Oct. 15, 2024 (GLOBE NEWSWIRE) -- 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 sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1), a rare, inherited and progressive motor neuron disease. EPISOD1 is a Phase I/II mul...
uniQure Announces Orphan Drug Designation Granted to AMT-191 for the T...
uniQure Announces Orphan Drug Designation Granted to AMT-191 for the Treatment of Fabry Disease LEXINGTON, Mass. and AMSTERDAM, Sept. 23, 2024 (GLOBE NEWSWIRE) -- 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 therapy for the treatment of Fabry disease, a rare, inherited genetic disease. In August 2024, uniQure announced the dosing of the first patient in its U.S., mu...
uniQure Announces Dosing of First Patient in Phase I/IIa Clinical Tria...
uniQure Announces Dosing of First Patient in Phase I/IIa Clinical Trial of AMT-191 for the Treatment of Fabry Disease LEXINGTON, Mass. and AMSTERDAM, Aug. 15, 2024 (GLOBE NEWSWIRE) -- 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, inherited genetic disease. The Phase I/IIa study is a multi-center, open-label trial being conducted in the United States with two dose-escala...
uniQure Announces Second Quarter 2024 Financial Results and Provides C...
uniQure Announces Second Quarter 2024 Financial Results and Provides Company Update ~ 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 ~ ~ Initiated patient screening for three additional Phase I/II studies in mesial temporal lobe epilepsy, SOD1 ALS, and Fabry disease ~ ~ Today, announced an organizational restructuring intended...
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