0001193125-19-146553.txt : 20190627 0001193125-19-146553.hdr.sgml : 20190627 20190514161555 ACCESSION NUMBER: 0001193125-19-146553 CONFORMED SUBMISSION TYPE: CORRESP PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20190514 FILER: 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: CORRESP 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 CORRESP 1 filename1.htm CORRESP

LOGO

May 14, 2019

VIA FEDEX AND EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Mail Stop 4546

Washington, D.C. 20549

Attention:

Keira Nakada

  

Jim Rosenberg

 

RE:

UroGen Pharma Ltd.

  

Form 10-K for the Fiscal Year Ended December 31, 2018

  

Filed February 28, 2019

  

File No. 001-38079

Dear Ms. Nakada and Mr. Rosenberg:

We are writing in response to a comment received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated May 7, 2019 (the “Comment Letter”) with respect to the Annual Report on Form 10-K for the fiscal year ended December 31, 2018, filed with the Commission on February 28, 2019 (the “Form 10-K”), of UroGen Pharma Ltd. (the “Company”). For your convenience, we have incorporated the text of the comment contained in the Comment Letter into this response letter.

Staff Comments and Company Responses

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.

Response: The Company hereby confirms that the Company’s disclosure regarding the serious adverse events described on page 12 of the Form 10-K describes all serious adverse events related to treatment with UGN-101 that are known at this time. Further, the Company confirms that it will continue to disclose all treatment-related serious adverse events in all applicable future filings with the Commission.

LOGO

 

The Company respectfully requests the Staff’s assistance in completing the review of the Company’s response as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response letter to the Company’s Chief Financial Officer, Peter Pfreundschuh, by mail at 499 Park Avenue, Suite 1200, New York, NY 10022 or by phone at +1-646-768-9531.

Sincerely,

 

UroGen Pharma Ltd.
/s/ Elizabeth Barrett
Elizabeth Barrett
Chief Executive Officer

 

cc:

Peter P. Pfreundschuh, CPA, MBA, Chief Financial Officer

  

Charles J. Bair, Esq., Cooley LLP

  

Asa M. Henin, Esq., Cooley LLP

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