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 Companys 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.
The Company respectfully requests the Staffs assistance in completing the review of the Companys 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 Companys 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 |