0000000000-19-015303.txt : 20191226 0000000000-19-015303.hdr.sgml : 20191226 20191107141416 ACCESSION NUMBER: 0000000000-19-015303 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20191107 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: uniQure N.V. CENTRAL INDEX KEY: 0001590560 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: PAASHEUVELWEG 25A CITY: AMSTERDAM STATE: P7 ZIP: 1105 BP BUSINESS PHONE: 1-339-970-7000 MAIL ADDRESS: STREET 1: PAASHEUVELWEG 25A CITY: AMSTERDAM STATE: P7 ZIP: 1105 BP FORMER COMPANY: FORMER CONFORMED NAME: uniQure B.V. DATE OF NAME CHANGE: 20131030 PUBLIC REFERENCE ACCESSION NUMBER: 0001558370-19-001305 LETTER 1 filename1.pdf begin 644 filename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Paasheuvelweg 25a 1105 BP Amsterdam The Netherlands Re: uniQure N.V. Form 10-K for the Fiscal Year Ended December 31, 2018 Filed February 28, 2019 File No. 001-36294 Dear Mr. Kapusta: We have reviewed your filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. Form 10-K for the Fiscal Year Ended December 31, 2018 Business, page 4 1. You make several assertions regarding the safety and efficacy of certain of your product candidates. For example, in your discussion on page 8 regarding an ongoing Phase I/II study of AMT-060, you disclose that "the data demonstrated that AMT-060 continues to be safe and well-tolerated, with no new serious adverse events and no development of inhibitors." In addition, in your discussion on page 11 of your preclinical SCA3 program, you disclose that these preclinical studies "demonstrate that AMT-150 appears to be safe due to a lack of off-target activity." Safety and efficacy determinations are solely within the authority of the FDA (or applicable foreign regulator). Please revise your future filings to remove statements/inferences that your product candidates are safe and/or effective. You may provide the objective results of the clinical trial in relation to the stated end points and indicate whether the candidates were well tolerated. Matthew Kapusta uniQure N.V. November 6, 2019 Page 2 Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Research and development expenses, page 70 2. Please revise your disclosure in future filings to quantify your research and development expenses by product candidate. To the extent that you do not track expenses by product candidate, please disclose as such. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. You may contact Lisa Vanjoske, Senior Staff Accountant at 202-551-3614 or Angela Connell, Accounting Branch Chief at 202-551-3426 if you have questions regarding the comments. FirstName LastNameMatthew Kapusta Sincerely, Comapany NameuniQure N.V. Division of Corporation Finance November 6, 2019 Page 2 Office of Life Sciences FirstName LastName