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| CIK | 1590560 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to uniQure N.V.
SEC Filings (Chronological Order)
Halaman ini menyediakan daftar lengkap dan kronologis dari Pengajuan SEC, tidak termasuk pengajuan kepemilikan yang kami sediakan di tempat lain.
| July 29, 2025 |
Exhibit 107 Calculation of Filing Fee Tables 424(b)(5) (Form Type) uniQure N.V. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered (1) Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Fees to Be Paid Equity |
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| July 29, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 29, 2025 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| July 29, 2025 |
Sales Agreement, dated July 29, 2025, by and between uniQure N.V. and Leerink Partners LLC. Exhibit 1.1 uniQure N.V. Up to $200,000,000 of Ordinary Shares (nominal value €0.05 per share) SALES AGREEMENT July 29, 2025 Leerink Partners LLC 1301 Avenue of the Americas, 5th Floor New York, New York 10019 Ladies and Gentlemen: uniQure N.V., a Dutch public company with limited liability (naamloze vennootschap) (the “Company”), confirms its agreement (this “Agreement”) with Leerink Partners LLC |
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| July 29, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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, 2025 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 |
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| July 29, 2025 |
Exhibit 99.1 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 |
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| July 29, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 29, 2025 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| July 29, 2025 |
Up to $200,000,000 Ordinary Shares TABLE OF CONTENTS Filed pursuant to Rule 424(b)(5) Registration No. 333-284168 PROSPECTUS SUPPLEMENT (To Prospectus dated January 7, 2025) Up to $200,000,000 Ordinary Shares We have entered into a sales agreement, or the Sales Agreement, with Leerink Partners LLC, or Leerink Partners, dated July 29, 2025, relating to the sale of our ordinary shares, nominal value €0.05 per share, offered by this |
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| June 30, 2025 |
As filed with the Securities and Exchange Commission on June 30, 2025 As filed with the Securities and Exchange Commission on June 30, 2025 Registration No. |
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| June 30, 2025 |
Exhibit 107 CALCULATION OF REGISTRATION FEE Form S-8 (Form Type) uniQure N.V. (Exact Name of Registrant as Specified in its Charter) Table 1—Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee(3) Equity Ordinary Shares, par value €0.0 |
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| June 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 11, 2025 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| June 13, 2025 |
Exhibit 10.1 uniQure N.V. 2014 Share Incentive Plan (Amended and Restated Effective as of June 11, 2025) 1.Purpose The purpose of this 2014 Share Incentive Plan, as herein amended and restated (the “Plan”) of uniQure N.V., a public limited company incorporated under the laws of the Netherlands (the “Company”), is to advance the interests of the Company’s shareholders by enhancing the Company’s abi |
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| June 2, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 2, 2025 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| June 2, 2025 |
Exhibit 99.1 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, MA and Amsterdam, the Netherlands, June 2, 2025 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative th |
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| May 9, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 9, 2025 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 9, 2025 |
Exhibit 10.1 AMENDED AND RESTATED EMPLOYMENT AGREEMENT This Amended and Restated Employment Agreement (“Agreement”) is entered into and effective as of April 15, 2025 (the “Effective Date”), by and between uniQure, Inc., 113 Hartwell Avenue, Lexington, MA 02421, on behalf of itself and any and all of its affiliates (together, the “Company”), and Matthew Craig Kapusta, [**] (“Executive” and togethe |
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| May 9, 2025 |
Amended and Restated uniQure N.V. Employee Stock Purchase Plan, effective as of April 15, 2025. Exhibit 10.2 AMENDED AND RESTATED UNIQURE N.V. EMPLOYEE STOCK PURCHASE PLAN The following constitute the provisions of the Amended and Restated uniQure N.V. Employee Stock Purchase Plan (as amended from time to time, the “Plan”). The Plan was originally effective and approved by the Company’s shareholders as of June 13, 2018 (the “Effective Date”), and was amended and restated effective as of Apri |
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| May 9, 2025 |
Exhibit 99.1 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 20 |
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| May 9, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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, 2025 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: 00 |
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| April 28, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permi |
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| April 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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| April 16, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 15, 2025 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| April 16, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permi |
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| February 27, 2025 |
Employment Agreement dated June 26, 2023 between Corlieve Therapeutics AG and Walid Abi-Saab. Exhibit 10.16 Employment Agreement by and between Corlieve Therapeutics AG c/o Switzerland Innovation Park Basel Area AG Hegenheimermattweg 167A 4123 Allschwil Switzerland and Walid Abi-Saab, M.D. Bannhollenweg 13 4143 Dornach Switzerland (the Employee) (the Company and the Employee are also referred to as Party or Parties) 1. Condition Precedent This employment agreement (the Employment Agreement |
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| February 27, 2025 |
Exhibit 4.1 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description sets forth certain material terms and provisions of uniQure N.V.’s (“uniQure N.V.”, “we,” “us,” and “our”) securities that are registered under Section 12 of the Securities Exchange Act of 1934, as amended. The description below of our ordinary s |
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| February 27, 2025 |
Exhibit 19.1 UNIQURE N.V. Insider Trading Policy (As of February 26, 2025) 1. BACKGROUND AND PURPOSE The prevention of insider trading is necessary to comply with securities laws and to preserve the reputation and integrity of uniQure N.V. (together with its subsidiaries, “uniQure” or the “Company”) as well as that of all persons affiliated with the Company. U.S. federal securities laws prohibit t |
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| February 27, 2025 |
Exhibit 21.1 February 27, 2025 SUBSIDIARIES OF UNIQURE N.V. Name of Subsidiary Jurisdiction of Organization uniQure biopharma B.V. The Netherlands uniQure IP B.V. The Netherlands uniQure Inc. Delaware uniQure France SAS France Corlieve Therapeutics AG Switzerland |
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| February 27, 2025 |
Exhibit 99.1 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 P |
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| February 27, 2025 |
Exhibit 14.1 UNIQURE N.V. Code Of Conduct (Amended as of February 27, 2024) 1. Introduction The Board of Directors (the “Board”) of uniQure N.V. and its subsidiaries (collectively, the “Company”) has adopted this code of conduct (as amended or modified from time to time by the Board, this “Code”), which sets forth legal and ethical standards of conduct for employees, directors and senior managers |
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| February 27, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-K 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, 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: 001-362 |
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| February 27, 2025 |
Exhibit 10.24 Peter Stalder Real Estate Real Estate Services and Construction Management Lease Agreement for Office Space Landlord uniQure (Corlieve Therapeutics AG) Swiss Innovation Park Hegenheimermattweg 167c CH-4123 Allschwil Rental Object Peter Merian-Weg 4, 4052 Basel Office and gallery space on the 5th floor, 685.01 m² 1 Lease Agreement Translation (English) Table of Contents 1. Parties 3 2 |
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| February 27, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 27, 2025 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| January 8, 2025 |
Exhibit 1.1 Execution Version uniQure N.V. 4,411,764 Ordinary Shares Underwriting Agreement January 7, 2025 Leerink Partners LLC 53 State Street, 40th Floor Boston, Massachusetts 02109 As representative (the “Representative”) of the several Underwriters named in Schedule I hereto Ladies and Gentlemen: uniQure N.V., a Dutch public company with limited liability (naamloze vennootschap) (the “Company |
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| January 8, 2025 |
uniQure Announces Pricing of its Public Offering Exhibit 99.1 uniQure Announces Pricing of its Public Offering Lexington, MA and Amsterdam, the Netherlands, January 8, 2025 — 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 pe |
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| January 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 7, 2025 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) ( |
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| January 8, 2025 |
TABLE OF CONTENTS Filed pursuant to Rule 424(b)(5) Registration No. 333-284168 Prospectus supplement (To prospectus dated January 7, 2025) 4,411,764 Ordinary Shares We are offering 4,411,764 ordinary shares pursuant to this prospectus supplement and the accompanying prospectus. Our ordinary shares are listed on The Nasdaq Global Select Market, or Nasdaq, under the symbol “QURE.” On January 7, 20 |
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| January 8, 2025 |
Exhibit 107 Calculation of Filing Fee Tables 424(b)(5) (Form Type) uniQure N.V. (Exact Name of Registrant as Specified in its Charter) Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Newly Registered S |
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| January 7, 2025 |
Form of subordinated indenture, with respect to the subordinated debt securities of uniQure N.V. Exhibit 4.2 UNIQURE N.V. and [ ] as Trustee INDENTURE Dated as of , 20 Subordinated Debt Securities TABLE OF CONTENTS Page ARTICLE I DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 Section 1.01 Definitions 1 Section 1.02 Compliance Certificates and Opinions 8 Section 1.03 Form of Documents Delivered to Trustee 8 Section 1.04 Acts of Holders; Record Dates 9 Section 1.05 Notices, Etc., to |
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| January 7, 2025 |
Subject to completion, dated January 7, 2025 TABLE OF CONTENTS The information in this preliminary prospectus supplement is not complete and may be changed. |
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| January 7, 2025 |
Form of convertible indenture, with respect to the convertible debt securities of uniQure N.V. Exhibit 4.3 UNIQURE N.V. and [ ] as Trustee INDENTURE Dated as of , 20 Convertible Debt Securities TABLE OF CONTENTS Page ARTICLE I DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 Section 1.01 Definitions 1 Section 1.02 Compliance Certificates and Opinions 8 Section 1.03 Form of Documents Delivered to Trustee 8 Section 1.04 Acts of Holders; Record Dates 9 Section 1.05 Noti |
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| January 7, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) uniQure N.V. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee |
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| January 7, 2025 |
As filed with the Securities and Exchange Commission on January 7, 2025 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 7, 2025 Registration No. |
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| January 7, 2025 |
Form of senior indenture, with respect to the senior debt securities of uniQure N.V. Exhibit 4.1 UNIQURE N.V. and [ ] as Trustee INDENTURE Dated as of , 20 Senior Debt Securities TABLE OF CONTENTS Page ARTICLE I DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 Section 1.01 Definitions 1 Section 1.02 Compliance Certificates and Opinions 7 Section 1.03 Form of Documents Delivered to Trustee 8 Section 1.04 Acts of Holders; Record Dates 8 Section 1.05 Notices, Etc., to Truste |
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| December 17, 2024 |
AGREEMENT REGARDING JOINT FILING OF STATEMENT ON SCHEDULE 13D OR 13G EXHIBIT 99.1 AGREEMENT REGARDING JOINT FILING OF STATEMENT ON SCHEDULE 13D OR 13G The undersigned agree to file jointly with the Securities and Exchange Commission (the “SEC”) any and all statements on Schedule 13D or Schedule 13G or Forms 3, 4 or 5(and any amendments or supplements thereto) required under section 13(d) and 16(a) of the Securities Exchange Act of 1934, as amended, in connection wi |
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| December 10, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 10, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| December 10, 2024 |
Exhibit 99.1 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 compos |
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| November 21, 2024 |
Exhibit 99.1 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, MA and Amsterdam, the Netherlands, November 21, 2024 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the first pat |
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| November 21, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 21, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| November 14, 2024 |
QURE / uniQure N.V. / Vestal Point Capital, LP Passive Investment SC 13G/A 1 p24-3218sc13ga.htm SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* uniQure N.V. (Name of Issuer) Ordinary shares, par value €0.05 per share (Title of Class of Securities) N90064101 (CUSIP Number) September 30, 2024 (Date of event which requires filing of this statement) Check the appropriate box to des |
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| November 13, 2024 |
QURE / uniQure N.V. / BRISTOL MYERS SQUIBB CO - SC 13G/A Passive Investment SC 13G/A 1 ef20038542sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* uniQure N.V. (Name of Issuer) Ordinary Shares (Title of Class of Securities) N90064101 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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| November 5, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 5, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| November 5, 2024 |
Exhibit 99.1 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 Huntingt |
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| November 5, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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 September 30, 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 |
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| October 25, 2024 |
QURE / uniQure N.V. / Boxer Capital Management, LLC Passive Investment SC 13G/A 1 ff403168113ga1-uniqure.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* uniQure, N.V. (Name of Issuer) Ordinary Shares, par value €0.05 per share (Title of Class of Securities) N90064101 (CUSIP Number) October 10, 2024 (Date of Event which Requires Filing of this Statement) Check the app |
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| October 25, 2024 |
JOINT FILING AGREEMENT PURSUANT TO RULE 13d-1(k) EX-2 2 ff4031681ex2-uniqure.htm JOINT FILING AGREEMENT PURSUANT TO RULE 13d-1(k) The undersigned acknowledge and agree that the foregoing statement on Schedule 13G in respect of the Ordinary Shares of uniQure, N.V. is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf of each of the undersigned without the necessit |
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| October 18, 2024 |
QURE / uniQure N.V. / STATE STREET CORP Passive Investment SC 13G/A 1 uniQureNV.htm SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* UNIQURE NV (Name of Issuer) COMMON STOCK (Title of Class of Securities) N90064101 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant to which this S |
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| October 15, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 15, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| October 15, 2024 |
Exhibit 99.1 uniQure Announces Dosing of First Patient in Phase I/II Clinical Trial of AMT-162 for the Treatment SOD1-ALS Lexington, MA and Amsterdam, the Netherlands, October 15, 2024 — 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 clinic |
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| September 23, 2024 |
uniQure Announces Orphan Drug Designation Granted to AMT-191 for the Treatment of Fabry Disease Exhibit 99.1 uniQure Announces Orphan Drug Designation Granted to AMT-191 for the Treatment of Fabry Disease Lexington, MA and Amsterdam, the Netherlands, September, 23, 2024 — 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 |
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| September 23, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 23, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number |
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| August 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 15, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) ( |
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| August 15, 2024 |
Exhibit 99.1 uniQure Announces Dosing of First Patient in Phase I/IIa Clinical Trial of AMT-191 for the Treatment of Fabry Disease Lexington, MA and Amsterdam, the Netherlands, August, 15, 2024 — 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/II |
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| August 1, 2024 |
As filed with the Securities and Exchange Commission on August 1, 2024 As filed with the Securities and Exchange Commission on August 1, 2024 Registration No. |
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| August 1, 2024 |
Termination Agreement, dated July 22, 2024, by and between uniQure biopharma B.V. and Pierre Caloz. Exhibit 10.5 TERMINATION AGREEMENT dated JULY 22, 2024 by UNIQURE BIOPHARMA B.V. Employer and PIERRE CALOZ Employee Termination Agreement This Agreement is dated July 22, 2024 Between uniQure biopharma B.V., Paasheuvelweg 25a, 1105 BP Amsterdam, The Netherlands (hereinafter the “Employer”); and Pierre Caloz, [***] (hereinafter the “Employee”). Recitals A. WHEREAS the Employee is currently employed |
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| August 1, 2024 |
Exhibit 10.1 Execution Version [**] CERTAIN INFORMATION HAS BEEN EXCLUDED PURSUANT TO REGULATION S-K, ITEM 601(B)(10)(IV) FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL ASSET PURCHASE AGREEMENT by and among UNIQURE INC., UNIQURE BIOPHARMA B.V., GENEZEN MA, INC. and GENEZEN HOLDINGS INC. Dated as of June 29, 2024 TABLE OF CON |
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| August 1, 2024 |
Exhibit 107 CALCULATION OF REGISTRATION FEE Form S-8 (Form Type) uniQure N.V. (Exact Name of Registrant as Specified in its Charter) Table 1—Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee(3) Equity Ordinary Shares, par value €0.0 |
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| August 1, 2024 |
Exhibit 99.1 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 |
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| August 1, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 1, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| August 1, 2024 |
Exhibit 10.3 LANDLORD CONSENT TO ASSIGNMENT AND ASSUMPTION OF LEASE AND THIRD AMENDMENT TO LEASE This Landlord Consent to Assignment and Assumption of Lease and Third Amendment to Lease (this “Agreement”) is made as of this 28th day of June, 2024 (the “Execution Date”), by and among HARTWELL INNOVATION CAMPUS, LLC, a Delaware limited liability company (“Landlord”), UNIQURE, INC., a Delaware corpor |
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| August 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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, 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 |
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| August 1, 2024 |
Exhibit 10.4 ASSIGNMENT AND ASSUMPTION OF LEASE This ASSIGNMENT AND ASSUMPTION OF LEASE (this “Assignment”) is made as of July 22, 2024 (“Execution Date”) by and between uniQure, Inc., a Delaware corporation (“Assignor”), and Genezen MA, Inc., a Delaware corporation (“Assignee”). WITNESSETH A.WHEREAS, Assignor and Assignee are parties to that certain Asset Purchase Agreement dated as of June 29, 2 |
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| August 1, 2024 |
Exhibit 10.2 Execution Version [***] CERTAIN INFORMATION HAS BEEN EXCLUDED PURSUANT TO REGULATION S-K, ITEM 601(B)(10)(IV) FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL CONSENT AND AMENDMENT NO. 2 TO THIRD AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT This CONSENT AND AMENDMENT NO. 2 TO THIRD AMENDED AND RESTATED LOAN AN |
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| July 23, 2024 |
Exhibit 99.1 uniQure Announces Closing of Sale of Manufacturing Facility to Genezen ~ uniQure maintains preferential access to industry-leading manufacturing capabilities to support its pipeline of gene therapy candidates ~ ~ Immediate reduction in cash burn, projected to save $40 million annually ~ Lexington, MA and Amsterdam, the Netherlands, July 23, 2024 — uniQure N.V. (NASDAQ: QURE), a leadin |
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| July 23, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 22, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| July 18, 2024 |
QURE / uniQure N.V. / Boxer Capital, LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 uniQure N.V. (Name of Issuer) Ordinary Shares, par value €0.05 per share (Title of Class of Securities) N90064101 (CUSIP Number) July 10, 2024 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which this Sch |
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| July 18, 2024 |
JOINT FILING AGREEMENT PURSUANT TO RULE 13d-1(k) EX-99 2 ex99113g-uniqure.htm Exhibit 99.1 JOINT FILING AGREEMENT PURSUANT TO RULE 13d-1(k) The undersigned acknowledge and agree that the foregoing statement on Schedule 13G in respect of the Common Stock of uniQure N.V. is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf of each of the undersigned without the ne |
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| July 9, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 9, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| July 9, 2024 |
Exhibit 99.1 uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase I/II Trials of AMT-130 for Huntington’s Disease ~ 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 Rati |
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| July 1, 2024 |
Exhibit 99.1 uniQure Announces Sale of Commercial Manufacturing Facility to Genezen ~ Proposed divestiture streamlines uniQure’s focus and represents an important milestone in its ongoing effort to significantly reduce operating expenses ~ ~ Genezen to manufacture global commercial supply of HEMGENIX® and support uniQure’s pipeline programs as a preferred customer ~ ~ uniQure to reduce cash burn b |
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| July 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 29, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| June 20, 2024 |
Exhibit 10.1 uniQure N.V. 2014 Share Incentive Plan (Amended and Restated effective as of November 15, 2023, as amended by the First Amendment effective as of November 15, 2023, as further amended by the Second Amendment effective as of June 18, 2024) 1. Purpose The purpose of this 2014 Share Incentive Plan, as herein amended and restated (the “Plan”) of uniQure N.V., a public limited company inco |
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| June 20, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 18, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| June 3, 2024 |
Exhibit 99.1 uniQure Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Investigational Gene Therapy AMT-130 in Huntington’s Disease ~ Designation based on 24-month interim Phase I/II clinical data for AMT-130 announced in December 2023 ~ ~ AMT-130 is the first therapeutic candidate to receive RMAT Designation for Huntington’s disease ~ ~ Receiving RMAT designation enables |
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| June 3, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 3, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 7, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 7, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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: 00 |
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| May 7, 2024 |
Exhibit 99.1 uniQure Announces First Quarter 2024 Financial Results and Highlights Recent Company Progress ~ 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 epil |
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| April 24, 2024 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permi |
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| April 24, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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| April 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 9, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| April 12, 2024 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permi |
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| February 28, 2024 |
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 clearan |
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| February 28, 2024 |
Exhibit 4.1 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description sets forth certain material terms and provisions of uniQure N.V.’s (“uniQure N.V.”, “we,” “us,” and “our”) securities that are registered under Section 12 of the Securities Exchange Act of 1934, as amended. The description below of our ordinary s |
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| February 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-K 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: 001-362 |
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| February 28, 2024 |
Exhibit 97.1 uniQure N.V. COMPENSATION CLAWBACK POLICY The Board of Directors (the “Board”) of uniQure N.V., a public company with limited liability (naamloze vennootschap) incorporated under the laws of the Netherlands (the “Company”), has adopted a Compensation Clawback Policy (this “Policy”) as described below. This Policy was originally effective on December 8, 2021 (“Effective Date”) and has |
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| February 28, 2024 |
As filed with the Securities and Exchange Commission on February 28, 2024 As filed with the Securities and Exchange Commission on February 28, 2024 Registration No. |
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| February 28, 2024 |
Exhibit 14.1 UNIQURE N.V. Code Of Conduct (Amended as of February 27, 2024) 1. Introduction The Board of Directors (the “Board”) of uniQure N.V. and its subsidiaries (collectively, the “Company”) has adopted this code of conduct (as amended or modified from time to time by the Board, this “Code”), which sets forth legal and ethical standards of conduct for employees, directors and senior managers |
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| February 28, 2024 |
Exhibit 107 CALCULATION OF REGISTRATION FEE Form S-8 (Form Type) uniQure N.V. (Exact Name of Registrant as Specified in its Charter) Table 1—Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee(3) Equity Ordinary Shares, par value €0.0 |
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| February 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 28, 2024 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| February 28, 2024 |
Employment Agreement dated June 13, 2023 between uniQure, Inc. and Jeannette Potts. Exhibit 10.77 Confidential EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (this “Agreement”) is made and entered into as of May 22, 2023 (the “Effective Date”), by and between uniQure, Inc., 113 Hartwell Avenue, Lexington, MA 02421 (the “Company”) and Jeannette Potts, Ph.D., J.D., an individual residing at [***] (the “Executive”). WITNESSETH: WHEREAS, the Company wishes to employ Executive as its |
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| February 28, 2024 |
Employment Agreement dated July 30, 2021 between Corlieve Therapeutics AG and Richard Porter. Exhibit 10.74 Employment Agreement dated 30 July 2021 (the Effective Date) by and between Corlieve Therapeutics AG, (the Company) Switzerland Innovation Park Basel Area AG Gewerbestrasse 24 4123 Allschwil, Switzerland and Richard Porter (the Employee) A British citizen born [***] in [***], England, and currently residing at [***] (The Company and the Employee are also referred to as Party or Parti |
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| February 28, 2024 |
Letter Agreement dated October 5, 2023, by and between Richard Porter and Corlieve Therapeutics AG. Exhibit 10.76 CONFIDENTIAL October 5, 2023 Richard Porter, Ph.D. uniQure Switzerland Innovation Park, Main Campus Hegenheimermattweg 167A 4123 Allschwil, Switzerland Dear Richard, We refer to the first amended employment agreement dated April 1, 2022, between Corlieve Therapeutics AG. (together with all of its affiliates, the “Company”) (the “Employment Agreement”). The Compensation Committee of t |
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| February 28, 2024 |
Exhibit 21.1 February 28, 2024 SUBSIDIARIES OF UNIQURE N.V. Name of Subsidiary Jurisdiction of Organization uniQure biopharma B.V. The Netherlands uniQure IP B.V. The Netherlands uniQure Inc. Delaware uniQure France SAS France Corlieve Therapeutics AG Switzerland |
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| February 28, 2024 |
Exhibit 10.75 First Amended Employment Agreement dated 1 April 2022 (the Effective Date) by and between Corlieve Therapeutics AG, (the Company) Switzerland Innovation Park Basel Area AG Gewerbestrasse 24 4123 Allschwil, Switzerland and Richard Porter (the Employee) A British citizen born [***] in [***], England, and currently residing at [***] (The Company and the Employee are also referred to as |
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| February 14, 2024 |
QURE / uniQure N.V. / Nantahala Capital Management, LLC - SC 13G/A Passive Investment SC 13G/A 1 tm243309d13sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 6)* uniQure N.V. (Name of Issuer) Ordinary Shares, par value €0.05 (Title of Class of Securities) N90064101 (CUSIP Number) December 31, 2023 (Date of Event which Requires Filing of this Statement) Check the appropria |
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| February 13, 2024 |
JOINT ACQUISITION STATEMENT PURSUANT TO RULE 13d-1(k) EX-99.1 2 exhibit99.htm JOINT ACQUISITION STATEMENT EXHIBIT 99.1 JOINT ACQUISITION STATEMENT PURSUANT TO RULE 13d-1(k) The undersigned acknowledge and agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G shall be filed on behalf of each of the undersigned without the necessity of filing |
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| February 13, 2024 |
QURE / uniQure N.V. / Vestal Point Capital, LP - UNIQURE N.V. Passive Investment SC 13G 1 p24-0810sc13g.htm UNIQURE N.V. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* uniQure N.V. (Name of Issuer) Ordinary shares, par value €0.05 per share (Title of Class of Securities) N90064101 (CUSIP Number) December 31, 2023 (Date of event which requires filing of this statement) Check the appropriate box |
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| December 19, 2023 |
Exhibit 99.1 uniQure Announces Update on Phase I/II Clinical Trials of AMT-130 Gene Therapy for the Treatment of Huntington’s Disease ~ Patients treated with AMT-130 continue to show evidence of preserved neurological function with potential dose-dependent clinical benefits relative to an inclusion criteria-matched natural history of the disease ~ ~ Mean CSF NfL continue to demonstrate favorable t |
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| December 19, 2023 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 19, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| December 8, 2023 |
As filed with the Securities and Exchange Commission on December 8, 2023 As filed with the Securities and Exchange Commission on December 8, 2023 Registration No. |
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| December 8, 2023 |
Exhibit 107 CALCULATION OF REGISTRATION FEE Form S-8 (Form Type) uniQure N.V. (Exact Name of Registrant as Specified in its Charter) Table 1—Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(2) Maximum Aggregate Offering Price(2) Fee Rate Amount of Registration Fee(2) Equity Ordinary Shares, par value € |
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| November 17, 2023 |
Exhibit 10.1 uniQure N.V. 2014 Share Incentive Plan (Amended and Restated effective as of November 15, 2023, as amended by the First Amendment effective as of November 15, 2023) 1. Purpose The purpose of this 2014 Share Incentive Plan, as herein amended and restated (the “Plan”) of uniQure N.V., a public limited company incorporated under the laws of the Netherlands (the “Company”), is to advance |
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| November 17, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 15, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| November 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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 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 |
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| November 7, 2023 |
Exhibit 10.1 October 4, 2023 Dear Ricardo, The purpose of this letter agreement (“Letter Agreement”) is to address the termination of your Employment Agreement for Good Reason and our mutual agreement to forego the Good Reason Process set forth in Section 19(f) thereof. Capitalized terms used but not defined in this Letter Agreement shall have the meaning set forth in the employment agreement betw |
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| November 7, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 7, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| November 7, 2023 |
Exhibit 99.1 uniQure Announces Third Quarter 2023 Financial Results and Highlights Recent Company Progress ~ Announced FDA clearance of Investigational New Drug (IND) application for AMT-260 in refractory mesial temporal lobe epilepsy ~ ~ On track to provide clinical update from U.S. and European Phase I/II trials of AMT-130 in Huntington’s disease later in the fourth quarter of 2023 ~ ~ uniQure a |
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| October 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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| October 6, 2023 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permi |
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| October 5, 2023 |
Exhibit 99.1 uniQure Announces Strategic Reorganization to Reduce Operating Expenses and Support Advancement of Multiple Clinical-Stage Programs ~ Reduction of 28% of workforce not related to HEMGENIX® manufacturing obligations; Total cost savings of $180 million to extend cash runway into second quarter of 2027 ~ ~ Discontinuing investments in more than half of research and technology projects, c |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 5, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) ( |
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| August 1, 2023 |
Exhibit 10.2 ROYALTY PURCHASE AGREEMENT1 dated as of May 12, 2023 between UNIQURE BIOPHARMA BV and HEMB SPV, L.P. 1 CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED (INDICATED BY: [***]) FROM THE EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE OR CONFIDENTIAL. TABLE OF CONTENTS Page ARTICLE 1 DEFINED TERMS |
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| August 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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 |
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| August 1, 2023 |
Exhibit 99.1 uniQure Announces Second Quarter 2023 Financial Results and Highlights Recent Company Progress ~ Announced encouraging interim analysis data from ongoing Phase I/II clinical trial of AMT-130 in Huntington’s disease showing preservation of function compared to baseline and clinical benefits relative to natural history; both dose cohorts of AMT-130 continue to be generally well-tolerate |
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| August 1, 2023 |
Exhibit 10.1 *Portions of this exhibit have been omitted for confidential treatment pursuant to Item 601(b)(10)(iv) of Regulation S-K* AMENDMENT NO. 1 TO THIRD AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT This AMENDMENT NO. 1 TO THIRD AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT (this “Amendment”), is dated as of May 12, 2023 and is entered into by and among (a) (i) UNIQURE BIOPHARMA B.V., |
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| August 1, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 1, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| June 22, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 20, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| June 22, 2023 |
Exhibit 99.1 uniQure announces achievement of $100 million milestone related to hemophilia B gene therapy ~ Milestone payment triggered by first commercial sale of HEMGENIX® in U.S. by CSL Behring ~ Lexington, MA and Amsterdam, the Netherlands, June 20, 2023 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, anno |
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| June 22, 2023 |
Exhibit 99.2 uniQure Announces Update on U.S. Phase I/II Clinical Trial of AMT-130 Gene Therapy for the Treatment of Huntington’s Disease ~ AMT-130 continues to be generally well-tolerated across both dose cohorts ~ ~ Patients treated with AMT-130 show preserved function compared to baseline and clinical benefits relative to natural history of the disease ~ ~ Neurofilament Light Chain (NfL) in cer |
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| June 16, 2023 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 13, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| May 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 12, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 16, 2023 |
Exhibit 99.1 uniQure Announces Sale of Royalty Interest in HEMGENIX® for Up To $400 Million ~ uniQure to receive $375 million upfront cash payment ~ ~ Under the existing agreement with CSL Behring, uniQure retains the rights to future milestones totaling up to $1.5 billion and maintains an interest in HEMGENIX® royalties ~ ~ Capped royalty financing provides uniQure non-equity-dilutive capital to |
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| May 9, 2023 |
† Consulting Agreement, effective March 31, 2023, by and between uniQure, Inc., and Alex Kuta Exhibit 10.1 CONSULTING AGREEMENT THIS CONSULTING AGREEMENT (the “Agreement”), made this March 31, 2023 (the “Effective Date”), is entered into by uniQure, Inc., a Delaware corporation with its principal place of business at 113 Hartwell Ave., Lexington, Massachusetts, 02421 (the “Company”), and Alex Kuta, an individual residing at [REDACTED] (the “Consultant” or the “Regulatory Consultant”). INTR |
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| May 9, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 9, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 9, 2023 |
EX-99.1 2 tm2315123d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 uniQure Announces First Quarter 2023 Financial Results and Highlights Recent Company Progress ~ Clinical update from U.S. Phase I/II trial in Huntington’s disease expected in second quarter 2023 ~ ~ Continued progress towards initiating two new Phase I/II clinical studies for AMT-260 in refractory temporal lobe epilepsy and AMT-162 in SOD1- |
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| May 9, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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, 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: 00 |
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| April 28, 2023 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permi |
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| April 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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| April 18, 2023 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permi |
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| April 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 31, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| February 27, 2023 |
Exhibit 21.1 February 27, 2023 SUBSIDIARIES OF UNIQURE N.V. Name of Subsidiary Jurisdiction of Organization uniQure biopharma B.V. The Netherlands uniQure IP B.V. The Netherlands uniQure Inc. Delaware Corlieve Therapeutics SAS France Corlieve Therapeutics AG Switzerland |
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| February 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 27, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| February 27, 2023 |
EX-4.1 2 qure-20221231xex4d1.htm EX-4.1 Exhibit 4.1 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description sets forth certain material terms and provisions of uniQure N.V.’s (“uniQure N.V.”, “we,” “us,” and “our”) securities that are registered under Section 12 of the Securities Exchange Act of 1934, as amended. |
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| February 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-K 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, 2022 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: 001-362 |
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| February 27, 2023 |
Exhibit 107 CALCULATION OF REGISTRATION FEE Form S-8 (Form Type) uniQure N.V. (Exact Name of Registrant as Specified in its Charter) Table 1—Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Ordinary Shares, par value €0.05 per |
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| February 27, 2023 |
As filed with the Securities and Exchange Commission on February 27, 2023 As filed with the Securities and Exchange Commission on February 27, 2023 Registration No. |
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| February 27, 2023 |
Exhibit 99.1 uniQure Announces 2022 Financial Results and Highlights Recent Company Progress ~ Achieved U.S. and European Commission marketing approvals of first and only gene therapy for adults with hemophilia B ~ ~ Advancing development of AMT-130 for patients with Huntington’s disease – clinical update from U.S. Phase I/II trial expected in second quarter 2023 ~ ~Hosted virtual investor event f |
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| February 21, 2023 |
Exhibit 99.1 uniQure announces the European Commission approval of the first gene therapy for adults with hemophilia B ~ Historic approval represents the first gene therapy in Europe to treat hemophilia B and provides a new treatment option for patients that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy, and generates elevated and sustained factor IX le |
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| February 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 21, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| February 14, 2023 |
QURE / uniQure N.V. / PFM Health Sciences, LP - SC 13G/A Passive Investment SC 13G/A 1 tm235475d12sc13g.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) Information Statement Pursuant to Rules 13d-1 and 13d-2 Under the Securities Exchange Act of 1934 (Amendment No. 1)* uniQure N.V. (Name of Issuer) Ordinary shares, par value €0.05 per share (Title of Class of Securities) N90064101 (CUSIP Number) December 31, |
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| February 14, 2023 |
QURE / uniQure N.V. / Nantahala Capital Management, LLC - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 5)* uniQure N.V. (Name of Issuer) Ordinary Shares, par value €0.05 (Title of Class of Securities) N90064101 (CUSIP Number) December 31, 2022 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to w |
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| February 14, 2023 |
SC 13G/A 1 pt7213ga.htm SCHEDULE 13G/A, AMENDMENT #1 240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* (Name of Issuer) uniQure N.V. (Title of Class of |
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| February 8, 2023 |
QURE / uniQure N.V. / Invesco Ltd. - SEC SCHEDULE 13G Passive Investment SC 13G/A 1 SEC13GFiling.htm SEC SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2 )* uniQure NV (Name of Issuer) Common Stock (Title of Class of Securities) N90064101 (CUSIP Number) December 30, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designat |
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| January 31, 2023 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 31, 2023 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| January 31, 2023 |
Exhibit 99.1 uniQure and Apic Bio enter into global licensing agreement for APB-102, a clinical stage gene therapy for patients with ALS caused by mutations in SOD1 ~ License of APB-102 further strengthens uniQure’s pipeline of innovative gene therapies to treat neurological disorders and miRNA-based gene silencing programs ~ ~APB-102 and uniQure’s c9orf72-ALS program have the potential to address |
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| December 16, 2022 |
Exhibit 99.1 uniQure announces positive CHMP opinion for etranacogene dezaparvovec ? gene therapy for adults with hemophilia B ~ If approved, etranacogene dezaparvovec would be the first licensed gene therapy in Europe for people living with hemophilia B ~ Lexington, MA and Amsterdam, the Netherlands, December 16, 2022 ? uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transfo |
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| December 16, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 16, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| November 28, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 21, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| November 23, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 22, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| November 23, 2022 |
Exhibit 99.1 uniQure announces FDA approval of first gene therapy for adults with hemophilia B ~ Historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy, and generates elevated and sustained factor IX levels ~ ~ uniQure conducted the multi-year clinical development program and will now leverage its leading ge |
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| November 2, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 2, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| November 2, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q 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 September 30, 2022 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 uniQur |
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| November 2, 2022 |
Exhibit 99.1 uniQure Announces Third Quarter 2022 Financial Results and Highlights Recent Company Progress ~ Patient enrollment at the higher dose of AMT-130 to resume in European Phase Ib/II study following Data Safety Monitoring Board recommendation ~ ~U.S. and European pre-approval inspections of Company?s Lexington, MA manufacturing site completed with EMA issuing Good Manufacturing Certificat |
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| September 26, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* uniQure N.V. (Name of Issuer) Ordinary Shares, ?0.05 par value per share (Title of Class of Securities) N90064 101 (CUSIP Number) July 1, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuan |
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| August 8, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q ? 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, 2022 ? ? ? OR ? ? ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? ? ? For the transition period from to ? ? ? Commission |
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| August 8, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 8, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| August 8, 2022 |
Exhibit 99.1 uniQure Announces Second Quarter 2022 Financial Results and Highlights Recent Company Progress ~ Announced 12-month data on the lower-dose cohort of AMT-130 in Huntington’s disease showed the investigative gene therapy was generally well tolerated at this dose with a mean reduction of 53.8% of mutant Huntingtin protein (mHTT) observed in cerebral spinal fluid (CSF) ~ ~ Announced postp |
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| July 18, 2022 |
EXHIBIT 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on Schedule 13G filed herewith (and any amendments thereto), relating to the ordinary shares of uniQure N.V., a private company with limited liability under the laws of the Netherlands, is being filed jointly with the Securities and Exchange Commission pursuant to Rule 13d-1(c) under the Securities Exchange Act of |
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| July 18, 2022 |
QURE / uniQure N.V. / PFM Health Sciences, LP - UNIQURE N.V. Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) Information Statement Pursuant to Rules 13d-1 and 13d-2 Under the Securities Exchange Act of 1934 (Amendment No. )* uniQure N.V. (Name of Issuer) Ordinary shares, par value ?0.05 per share (Title of Class of Securities) N90064101 (CUSIP Number) July 7, 2022 (Date of Event Which Requires Filing of th |
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| June 15, 2022 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 14, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| May 24, 2022 |
Exhibit 99.1 uniQure Announces FDA Acceptance of Biologics License Application for Etranacogene Dezaparvovec under Priority Review ~ If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with hemophilia B ~ Lexington, MA and Amsterdam, the Netherlands, May 24, 2022 ? uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative thera |
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| May 24, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 24, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 2, 2022 |
Exhibit 99.1 uniQure Announces First Quarter 2022 Financial Results and Highlights Recent Company Progress ~ Partner CSL Behring submitted Marketing Authorization Application (MAA) in Europe for etranacogene dezaparvovec in hemophilia B; MAA validated by the European Medicines Agency (EMA) and granted accelerated assessment ~ ~ Received $55 million in milestone payments associated with global subm |
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| May 2, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 2, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 2, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q ? 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, 2022 ? ? ? OR ? ? ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? ? ? For the transition period from to ? ? ? Commission |
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| April 29, 2022 |
DEF 14A 1 tm223584d2def14a.htm DEF 14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Comm |
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| April 19, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant ? Check the appropriate box: x Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6 |
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| March 22, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 21, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| March 22, 2022 |
Exhibit 99.1 uniQure Announces Completion of Patient Enrollment in the First Two Cohorts of its Phase I/II Clinical Trial of AMT-130 for the Treatment of Huntington?s Disease Lexington, MA and Amsterdam, the Netherlands, March 21, 2022 ? uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the complet |
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| February 28, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 25, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| February 28, 2022 |
Exhibit 99.1 uniQure Announces 2021 Financial Results and Highlights Recent Company Progress ~ Data from largest gene therapy study in hemophilia B showed sustained therapeutic effect at 18-months and statistical superiority in reducing annualized bleeding rate compared to baseline FIX prophylactic therapy; Submissions of marketing applications on track for the first half of 2022 ~ ~ Data from fir |
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| February 25, 2022 |
? Exhibit 10.70 ? *Portions of this exhibit have been omitted for confidential treatment pursuant to Item 601(b)(10)(iv) of Regulation S-K. ? ? LEASE ? BY AND BETWEEN ? NRL 91 HARTWELL LLC (?Landlord?) ? and ? UNIQURE, INC. (?Tenant?) ? ? ? ? ? TABLE OF CONTENTS ? ? ? ? ? ? ? ? Page 1. TERMS ? 1 ? ? ? ? 2. THE PREMISES ? 4 ? ? ? ? 3. TERM ? 4 ? ? ? ? 4. CONDITION OF THE PREMISES ? 5 ? ? ? ? 5. MON |
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| February 25, 2022 |
Exhibit 10.68 ? EXECUTION VERSION ? ? *Portions of this exhibit have been omitted for confidential treatment pursuant to Item 601(b)(10)(iv) of Regulation S-K. ? UNIQURE ? THIRD AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT ? THIS THIRD AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT is made and dated as of December 15, 2021 and is entered into by and among (i) UNIQURE BIOPHARMA B.V., a privat |
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| February 25, 2022 |
Exhibit 10.67 ? *Portions of this exhibit have been omitted for confidential treatment pursuant to Item 601(b)(10)(iv) of Regulation S-K. ? uniQure N.V. ? Performance Share Unit Agreement Granted Under the 2014 Share Incentive Plan, Amended and Restated effective as of June 16, 2021 (the ?Plan?) ? EXHIBIT A General Terms and Conditions ? 1.Performance Share Unit Grant. ? (a)This Performance-Based |
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| February 25, 2022 |
Exhibit 10.69 ? EXECUTION COPY ? ? *Portions of this exhibit have been omitted for confidential treatment pursuant to Item 601(b)(10)(iv) of Regulation S-K. ? ? LEASE ? BETWEEN ? UNIQURE, INC., AS TENANT ? AND ? G&I IX/GP4 20 MAGUIRE LLC, AS LANDLORD ? 20 MAGUIRE ROAD, LEXINGTON, MASSACHUSETTS ? The submission of an unsigned copy of this document to Tenant for Tenant?s consideration does not const |
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| February 25, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-K Table of Contents ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D. |
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| February 25, 2022 |
Exhibit 10.66 ? uniQure N.V. Restricted Share Unit Agreement Granted Under 2014 Share Incentive Plan, Amended and Restated effective as of June 16, 2021 (the ?Amendment Date?) ? General Terms and Conditions ? 1.Restricted Share Unit Grant. This Restricted Share Unit Grant Agreement (this ?Agreement?) together with the Notice of Grant evidences the grant by the Company, on the Award Date to the Par |
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| February 25, 2022 |
Form of Share Option Agreement, effective December 8, 2021, under the 2014 Share Incentive Plan. Exhibit 10.65 uniQure N.V. Share Option Agreement Granted Under 2014 Share Incentive Plan, Amended and Restated effective as of June 16, 2021 (the ?Amendment Date?) ? 1.Grant of Option. This agreement together with the Notice of Grant evidences the grant by uniQure N.V., a public limited company incorporated under the laws of the Netherlands (the ?Company?), on the ?Award Date? to the ?Participant |
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| February 25, 2022 |
Exhibit 21.1 February 25, 2022 SUBSIDIARIES OF UNIQURE N.V. ? ? ? ? ? Name of Subsidiary Jurisdiction of Organization ? uniQure biopharma B.V. ? The Netherlands ? uniQure IP B.V. ? The Netherlands ? uniQure Inc. ? Delaware ? Corlieve Therapeutics SAS ? France ? Corlieve Therapeutics AG ? Switzerland ? ? |
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| February 25, 2022 |
Exhibit 4.1 DESCRIPTION OF THE REGISTRANT?S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description sets forth certain material terms and provisions of uniQure N.V.?s (?uniQure N.V.?, ?we,? ?us,? and ?our?) securities that are registered under Section 12 of the Securities Exchange Act of 1934, as amended. The description below of our ordinary s |
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| February 14, 2022 |
QURE / uniQure N.V. / Nantahala Capital Management, LLC - SC 13G/A Passive Investment SC 13G/A 1 tm222623d40sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 4)* uniQure N.V. (Name of Issuer) Ordinary Shares, par value €0.05 (Title of Class of Securities) N90064101 (CUSIP Number) December 31, 2021 (Date of Event which Requires Filing of this Statement) Check the appropria |
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| February 11, 2022 |
QURE / uniQure N.V. / Point72 Asset Management, L.P. - SCHEDULE 13G Passive Investment SC 13G 1 pt7213ga.htm SCHEDULE 13G 240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.)* (Name of Issuer) uniQure N.V. (Title of Class of Securities) Ordinary |
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| February 11, 2022 |
QURE / uniQure N.V. / ForUniqure B.V. - SC 13G/A Passive Investment SC 13G/A 1 d294772dsc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 3)* uniQure N.V. (Name of Issuer) Common Stock, par value EUR 0.05 per share (Title of Class of Securities) N90064101 (CUSIP Number) 31 DECEMBER 2021 (Date of Event Which Requires Filing of this Statement) Check the app |
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| February 11, 2022 |
Exhibit 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned in accordance with the provisions of Rule 13d-1(k) under the Securities Exchange Act of 1934, as amended, and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf of each of the undersigned without the necessi |
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| February 10, 2022 |
QURE / uniQure N.V. / Invesco Ltd. - SEC SCHEDULE 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1 )* uniQure NV (Name of Issuer) Common Stock (Title of Class of Securities) N90064101 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which this Schedule is |
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| February 8, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 7, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| February 8, 2022 |
Exhibit 99.1 uniQure Announces Dosing of First Patients in European Open-Label Clinical Trial of AMT-130 Gene Therapy in Huntington?s Disease Lexington, MA and Amsterdam, the Netherlands, February 7, 2022 ? uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the dosing of the first two patients in it |
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| February 4, 2022 |
Entry into a Material Definitive Agreement UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 1, 2022 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| December 28, 2021 |
Entry into a Material Definitive Agreement UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 22, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| December 17, 2021 |
Exhibit 99.1 uniQure Announces Clinical Update on First Patients in Phase I/II Clinical Trial of AMT-130 Gene Therapy for the Treatment of Huntington?s Disease ~ Treatment was well tolerated with no significant safety issues related to AMT-130 in first two treated patients through one year of follow-up ~ ~ Neurofilament Light Chain (NfL) rose as expected immediately following surgery and returned |
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| December 17, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 15, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| December 13, 2021 |
Exhibit 99.1 uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B ~ Largest gene therapy study in hemophilia B achieved primary endpoint of non-inferiority in annualized bleeding rate after stable Factor IX (FIX) expression, assessed at 18 months following a single dose of etranacogene dezaparvove |
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| December 13, 2021 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 9, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| October 25, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 25, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| October 25, 2021 |
Exhibit 99.1 uniQure Announces Third Quarter 2021 Financial Results and Highlights Recent Company Progress ~ Completed 78-week follow-up for hemophilia B pivotal study, with top-line data expected by year-end 2021 ~ ~ Enrolled 14 patients to date in Phase 1/2 clinical trial of AMT-130 in Huntington?s Disease, with no significant safety concerns observed ~ ~ Preliminary data on first four patients |
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| October 25, 2021 |
Certain identified information has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. |
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| October 25, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q ? 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 September 30, 2021 ? ? ? OR ? ? ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? ? ? For the transition period from to ? ? ? Commis |
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| October 21, 2021 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 21, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) |
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| September 17, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.) Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confiden |
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| July 30, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 30, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| July 27, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 26, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| July 27, 2021 |
Exhibit 99.1 uniQure Announces Second Quarter 2021 Financial Results and Highlights Recent Company Progress ~ Expanded gene therapy pipeline with four new research programs and announced acquisition of Corlieve Therapeutics ~ ~ Presented positive 52-week data from HOPE-B pivotal study demonstrating sustained increases in Factor IX (FIX) levels with mean FIX activity of 41.5 percent of normal and s |
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| July 26, 2021 |
HOLDINGA MATTHIJSSEN KRAAK Exhibit 3.1 NOTE ABOUT TRANSLATION: This document is an English translation of a document prepared in Dutch. In preparing this document, an attempt has been made to translate as literally as possible without jeopardizing the overall continuity of the text. Inevitably, however, differences may occur in translation and if they do, the Dutch text will govern by law. In this |
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| July 26, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q ? 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, 2021 ? ? ? OR ? ? ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? ? ? For the transition period from to ? ? ? Commission |
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| July 26, 2021 |
Exhibit 10.3 ? EMPLOYMENT AGREEMENT PURSUANT TO SECTION 7:610 (et seq.) of the Dutch Civil Code (DCC) June 15, 2021 Employment agreement between (1) uniQure biopharma B.V., a company with limited liability (besloten vennootschap met beperkte aansprakelijkheid), with registered office at Amsterdam and principal place of business at Paasheuvelweg 25a, (1105 BP) Amsterdam (the Employer); and (2) Chri |
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| July 26, 2021 |
Exhibit 4.1 ? uniQure N.V. ? 2014 Share Incentive Plan ? (Amended and Restated effective as of June 16, 2021) ? 1. Purpose ? The purpose of this 2014 Share Incentive Plan, as herein amended and restated (the ?Plan?) of uniQure N.V., a public limited company incorporated under the laws of the Netherlands (the ?Company?), is to advance the interests of the Company?s shareholders by enhancing the Com |
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| July 26, 2021 |
Exhibit 10.2 ? ? ? Jamie Brady ? Chief Human Resources Officer ? ? ? May 17, 2021 ? Pierre Caloz ? RE: Side Letter Agreement re Equity Grants ? Dear Pierre, ? Subject to Board of Directors approval at the next regularly scheduled uniQure N.V. Board meeting after the execution of this Agreement and subject to the commencement of employment pursuant to your employment agreement with uniQure biopharm |
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| July 26, 2021 |
Exhibit 10.1 ? ? Employment Agreement dated 17 May 2021 by and between ? uniQure biopharma B.V., (the Company) Paasheuvelweg 25a 1105 BP Amsterdam The Netherlands ? and ? ? Pierre Caloz (the Employee) ? ? (The Company and the Employee are also referred to as Party or Parties) ? 1 of 31 Employment Agreement Table of Contents ? 1. Condition Precedent 5 ? ? ? 2. Commencement Date 5 ? ? ? 3. Function |
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| July 26, 2021 |
Exhibit 2.1 ? [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. SALE AND PURCHASE AGREEMENT ? by and among ? UNIQURE N.V. ? and ? EACH OF THE SHAREHOLDERS OF CORLIEVE THERAPEUTICS PARTY HERETO, ? and ? THE |
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| July 20, 2021 |
As filed with the Securities and Exchange Commission on July 20, 2021 As filed with the Securities and Exchange Commission on July 20, 2021 Registration No. |
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| June 23, 2021 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 21, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| June 23, 2021 |
Exhibit 99.2 uniQure Announces Positive 52-Week Clinical Data from HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B and Provides Regulatory Update ~ Sustained increases in Factor IX (FIX) levels with mean FIX activity of 41.5 percent of normal in full study population one year following a single administration of etranacogene dezaparvovec ~ ~ Held pre-BL |
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| June 23, 2021 |
Exhibit 99.1 uniQure to Acquire Corlieve Therapeutics and Advance its Gene Therapy Program to Treat Temporal Lobe Epilepsy (TLE) ~ Expands uniQure?s Pipeline of Innovative Gene Therapies to Treat Neurological Disorders ~ ~ Strengthens uniQure?s Global Leadership in the Development of Gene Therapies that Employ miRNA Silencing Technology ~ ~ Large Opportunity Targeting an Estimated 1.3 million TLE |
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| June 21, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 15, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| May 21, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 17, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 10, 2021 |
? 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, 2021 ? ? ? OR ? ? ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? ? ? For the transition period from to ? ? ? Commission |
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| May 10, 2021 |
EXECUTION COPY Exhibit 10.1 COOPERATION AGREEMENT between UNIQURE N.V. and FORUNIQURE B.V. and FORBION 1 MANAGEMENT B.V. and FORBION INTERNATIONAL MANAGEMENT B.V. and FORBION CAPITAL PARTNERS MANAGEMENT HOLDING B.V. 16 April 2021 ? ? Cooperation agreement 1 ? EXECUTION COPY This cooperation agreement (this ?Agreement?) is dated 16 April 2021 and entered into between: (1) uniQure N.V., a public com |
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| May 10, 2021 |
Exhibit 99.1 uniQure Announces First Quarter 2021 Financial Results and Highlights Recent Company Progress ~ 52-week follow-up data from HOPE-B pivotal study expected to be presented later this quarter ~ ~ Announced closing of the global commercialization and license agreement with CSL Behring for hemophilia B gene therapy ~ ~ Completed enrollment of first dose cohort of U.S. Phase I/II clinical t |
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| May 10, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 10, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| May 7, 2021 |
Exhibit 99.1 uniQure announces closing of commercialization and license agreement with CSL Behring ~Upfront payment of $450 million due to uniQure by May 13, 2021~ Lexington, MA and Amsterdam, the Netherlands, May 6, 2021 ? uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the waiting period u |
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| May 7, 2021 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 6, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS |
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| April 30, 2021 |
7,4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )* uniQure N.V. (Name of Issuer) Ordinary Shares, €0.05 par value per share (Title of Class of Securities) N90064 101 (CUSIP Number) April 21, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pu |
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| April 30, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant o Check the appropriate box: ? Preliminary Proxy Statement ? Confide |
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| April 26, 2021 |
uniQure Announces FDA Removes Clinical Hold on Hemophilia B Gene Therapy Program Exhibit 99.1 uniQure Announces FDA Removes Clinical Hold on Hemophilia B Gene Therapy Program Lexington, MA and Amsterdam, the Netherlands, April 26, 2021 ? uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Compan |
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| April 26, 2021 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 23, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| April 22, 2021 |
Entry into a Material Definitive Agreement, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 16, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| April 20, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14A-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant o Check the appropriate box: x Preliminary Proxy Statement ? Confide |
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| April 5, 2021 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 5, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| April 5, 2021 |
Exhibit 99.1 uniQure Announces Completion of Enrollment in First Cohort of Phase I/II Clinical Trial of AMT-130 for the Treatment of Huntington?s Disease ~ Enrollment of second dose cohort expected to begin in 3Q 2021 ~ ~ Company announces plans to initiate a second clinical study of AMT-130 in Europe in the second half of 2021 ~ Lexington, MA and Amsterdam, the Netherlands, April 5, 2021 ? uniQur |
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| April 1, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 29, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (I |
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| April 1, 2021 |
Exhibit 99.1 uniQure Announces Findings from Reported Case of Hepatocellular Carcinoma (HCC) in Hemophilia B Gene Therapy Program ~ Independent investigation shows that etranacogene dezaparvovec is highly unlikely to be the cause of HCC in HOPE-B pivotal trial ~ ~ Data from investigation submitted to U.S Food and Drug Administration (FDA) on March 26, 2021 ~ Lexington, MA and Amsterdam, the Nether |
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| March 2, 2021 |
Use these links to rapidly review the document Prospectus Supplement TABLE OF CONTENTS Table of Contents Filed pursuant to Rule 424(b)(5) Registration No. |
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| March 2, 2021 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 1, 2021 uniQure N.V. (Exact Name of Registrant as Specified in Charter) The Netherlands 001-36294 N/A (State or Other Jurisdiction of Incorporation) (Commission File Number) (IR |
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| March 2, 2021 |
Sales Agreement dated March 1, 2021 by and between uniQure N.V. and SVB Leerink LLC Exhibit 1.1 uniQure N.V. Up to $200,000,000 of Ordinary Shares (nominal value ?0.05 per share) SALES AGREEMENT March 1, 2021 SVB LEERINK LLC 1301 Avenue of the Americas, 12th Floor New York, New York 10019 Ladies and Gentlemen: uniQure N.V., a Dutch public company with limited liability (naamloze vennootschap) (the ?Company?), confirms its agreement (this ?Agreement?) with SVB Leerink LLC (? SVB L |
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| March 1, 2021 |
Exhibit 99.1 uniQure Announces 2020 Financial Results and Highlights Recent Company Progress ~ Six patient procedures now completed in Phase I/II for Huntington’s disease, including two procedures conducted in February 2021, with full enrollment of first cohort expected mid-2021 ~ ~ Last patient in HOPE-B pivotal study to complete 52-week follow-up visit before end of the first quarter of 2021, wi |
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| March 1, 2021 |
Table of Contents ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D. |
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| March 1, 2021 |
Exhibit 10.57 ? Confidential Execution Version ? *Portions of this exhibit have been omitted for confidential treatment pursuant to Item 601(b)(10)(iv) of Regulation S-K. ? AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT ? This AMENDMENT TO THE COLLABORATION AND LICENSE AGREEMENT (the ?Amendment?) is effective as of December 1, 2020 (the ?Amendment Effective Date?), by and between UNIQURE BIOPHAR |
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| March 1, 2021 |
Form of senior indenture, with respect to the senior debt securities of uniQure N.V. Exhibit 4.1 UNIQURE N.V. and [ ] as Trustee INDENTURE Dated as of , 20 Senior Debt Securities TABLE OF CONTENTS Page ARTICLE I DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 Section 1.01 Definitions 1 Section 1.02 Compliance Certificates and Opinions 7 Section 1.03 Form of Documents Delivered to Trustee 8 Section 1.04 Acts of Holders; Record Dates 8 Section 1.05 Notices, Etc., to Truste |
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| March 1, 2021 |
Exhibit 4.1 DESCRIPTION OF THE REGISTRANT?S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description sets forth certain material terms and provisions of uniQure N.V.?s (?uniQure N.V.?, ?we,? ?us,? and ?our?) securities that are registered under Section 12 of the Securities Exchange Act of 1934, as amended. The description below of our ordinary s |
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| March 1, 2021 |
Exhibit 21.1 March 1, 2021 SUBSIDIARIES OF UNIQURE N.V. ? ? ? ? ? Name of Subsidiary Jurisdiction of Organization ? uniQure biopharma B.V. ? The Netherlands ? uniQure IP B.V. ? The Netherlands ? uniQure Inc. ? Delaware ? ? |
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| March 1, 2021 |
Exhibit 10.58 ? EXECUTION VERSION ? *Portions of this exhibit have been omitted for confidential treatment pursuant to Item 601(b)(10)(iv) of Regulation S-K. AMENDMENT NO. 2 TO SECOND AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT ? This AMENDMENT NO. 2 TO SECOND AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT (this ?Amendment?), is dated as of January 29, 2021 and is entered into by and among |
