May 14, 2019
VIA FEDEXAND 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. |
Form10-K for the Fiscal Year Ended December 31, 2018 |
Filed February 28, 2019 |
FileNo. 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 Form10-K for the fiscal year ended December 31, 2018, filed with the Commission on February 28, 2019 (the “Form10-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 ofUGN-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 withUGN-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 Form10-K describes all serious adverse events related to treatment withUGN-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 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 |