0000000000-19-008192.txt : 20190627 0000000000-19-008192.hdr.sgml : 20190627 20190508113323 ACCESSION NUMBER: 0000000000-19-008192 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20190508 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: UroGen Pharma Ltd. CENTRAL INDEX KEY: 0001668243 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 9 HA'TA'ASIYA ST CITY: RA'ANANA STATE: L3 ZIP: 4365007 BUSINESS PHONE: 972 9 770 7601 MAIL ADDRESS: STREET 1: 9 HA'TA'ASIYA ST CITY: RA'ANANA STATE: L3 ZIP: 4365007 PUBLIC REFERENCE ACCESSION NUMBER: 0001564590-19-005323 LETTER 1 filename1.pdf begin 644 filename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Form 10-K for the Fiscal Year Ended December 31, 2018 Filed February 28, 2019 File No. 001-38079 Dear Ms. Barrett: We have reviewed your filing and have the following comment. In our comment, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this comment 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 comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this comment, we may have additional comments. Form 10-K for the year ended December 31, 2018 Item 1. Business Initial Clinical Results of UGN-101, page 11 1. We note the serious adverse events described on page 12. It is not clear from your disclosure whether you have described all serious adverse events related to treatment with UGN-101. Please confirm that you will disclose all treatment-related serious adverse events in all applicable future filings. 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. Elizabeth Barrett UroGen Pharma Ltd. May 7, 2019 Page 2 You may contact Keira Nakada at 202-551-3659 or Jim Rosenberg at 202-551-5679 with any questions. FirstName LastNameElizabeth Barrett Sincerely, Comapany NameUroGen Pharma Ltd. Division of Corporation Finance May 7, 2019 Page 2 Office of Healthcare & Insurance FirstName LastName