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uniQure Announces Sale of Commercial Manufacturing Facility to Genezen
GlobeNewswire News Room· 2024-07-01 11:05
~ Genezen to manufacture global commercial supply of HEMGENIX® and support uniQure's pipeline programs as a preferred customer ~ Genezen agreed to acquire uniQure's commercial-scale gene-therapy manufacturing facility for total consideration of $25 million, comprised of $12.5 million of newly issued Series C Preferred Stock and a $12.5 million convertible note. In addition, Matt Kapusta, chief executive officer of uniQure, will join the Board of Genezen upon the closing of the transaction, which is expected ...
uniQure Announces Sale of Commercial Manufacturing Facility to Genezen
Newsfilter· 2024-07-01 11:05
~ Genezen to manufacture global commercial supply of HEMGENIX® and support uniQure's pipeline programs as a preferred customer ~ ~ uniQure's comprehensive review of operations and options to reduce expenses is ongoing and expected to be complete in the third quarter of 2024 ~ Under the proposed transaction, Genezen will be responsible for manufacturing global commercial supply of HEMGENIX® for CSL and providing development and manufacturing services to support uniQure's investigational gene therapies. uniQu ...
uniQure Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Investigational Gene Therapy AMT-130 in Huntington's Disease
Newsfilter· 2024-06-03 11:05
~ Designation based on 24-month interim Phase I/II clinical data for AMT-130 announced in December 2023 ~ LEXINGTON, Mass. and AMSTERDAM, June 03, 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 Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational gene therapy AMT-130 for the treatment of Hunti ...
uniQure(QURE) - 2024 Q1 - Quarterly Results
2024-05-07 12:03
uniQure Announces First Quarter 2024 Financial Results and Highlights Recent Company Progress Exhibit 99.1 ~ On track to initiate FDA interaction regarding AMT-130 in second quarter of 2024 and provide a clinical update from the Phase I/II trials in mid-2024 ~ ~ Clinical trial initiation for Fabry disease on track to begin in second quarter of 2024, followed by refractory mesial temporal lobe epilepsy and SOD1-ALS in third quarter of 2024 ~ ~ Comprehensive review of operations and options to reduce expenses ...
uniQure(QURE) - 2024 Q1 - Quarterly Report
2024-05-07 11:57
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) The Netherlands (Sta ...
uniQure(QURE) - 2023 Q4 - Annual Results
2024-02-28 13:00
Exhibit 99.1 uniQure Announces 2023 Financial Results and Highlights Recent Company Progress ~ Presented promising clinical update from U.S. and European Phase I/II trials of AMT-130 in Huntington's disease; Up to three years of follow-up data to be presented in mid-2024; Regulatory interactions and clarity on potential strategies for clinical development expected in 2024 ~ ~ Announced FDA clearance of two Investigational New Drug (IND) applications; Initiation of Phase I/II clinical trials in mesial tempor ...
uniQure(QURE) - 2023 Q4 - Annual Report
2024-02-28 12:51
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) The Netherlands (Jurisdiction of incorpor ...
uniQure(QURE) - 2023 Q3 - Quarterly Report
2023-11-07 12:52
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 The Netherlands FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) ...
uniQure(QURE) - 2023 Q2 - Quarterly Report
2023-08-01 11:37
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) The Netherlands (Stat ...
uniQure(QURE) - 2023 Q1 - Quarterly Report
2023-05-09 11:20
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of Registrant as specified in its charter) Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 uniQure N.V. The Netherlands (Sta ...