May 29, 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 17, 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 acknowledge your response to our comment. Please confirm that you will revise your disclosure in your applicable future filing to clearly state that the serious adverse events you list relate to treatment with UGN-101. In addition, please also confirm that you will disclose the frequency in which these serious adverse events occurred. |
Response: The Company hereby confirms that it will revise its disclosure in all applicable future filings with the Commission to clearly state the serious adverse events that relate to treatment with UGN-101. Further, the Company confirms that it will disclose the frequency in which these serious adverse events occurred.
499 Park Avenue, Suite 1200, New York, NY 10022 | 646-768-9780
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 |
499 Park Avenue, Suite 1200, New York, NY 10022 | 646-768-9780