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UroGen Pharma Ltd. (URGN)
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Create: Alert |
All | News | Filings
| Date Filed | Type | Description |
| 11/13/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"FORM 6-K",
"Unaudited Condensed Consolidated Interim Balance Sheets as of September 30, 2018 and December 31, 2017, Unaudited Condensed Consolidated Interim Statements of Operations for the nine and three months ended September 30, 2018 and 2017, Unaudited Condensed Consolidated Interim Statements of Changes in Shareholders’ Equity and Statements of Cash Flows for the nine months ended September 30, 2018 and 2017 and Notes to the Condensed Consolidated Financial Statements",
"UROGEN PHARMA LTD. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS",
"UGN-102 Clinical Development: o UroGen is enrolling patients as part of its Phase 2b single-arm, open-label, multi-center trial designed to assess the efficacy and safety of UGN-102 for intravesical instillation as a potential first-line chemoablation agent in the treatment of patients with LG Non-Muscle Invasive Bladder Cancer at risk for recurrence. o Initial data from the trial is expected in 1H 2019. o Similar to LG UTUC, there are currently no drugs approved by the FDA as first-line treatment for NMIBC, and only three drugs have been approved by the FDA, all as adjuvant treatments, following TURBT . 1 o UGN-102 represents a very substantial opportunity in UroGen’s pipeline with the potential to initially address up to approximately 85,000 patients for whom TURBT is no longer effective..." |
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| 10/31/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 09/28/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 09/21/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 09/18/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 08/30/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 08/14/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"FORM 6-K",
"Unaudited Condensed Consolidated Interim Balance Sheets as of June 30, 2018 and December 31, 2017, Unaudited Condensed Consolidated Interim Statements of Operations for the six and three months ended June 30, 2018 and 2017, Unaudited Condensed Consolidated Interim Statements of Changes in Shareholders’ Equity and Statements of Cash Flows for the six months ended June 30, 2018 and 2017 and Notes to the Consolidated Financial Statements",
"Management’s Discussion and Analysis of Financial Condition and Results of Operations",
"UGN-101 Regulatory and Clinical Development: o Announced positive findings from an interim analysis of the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101, an investigational mitomycin formulation for the non-surgical treatment of LG UTUC in May 2018. ▪ Interim analysis showed a complete response rate of 59 percent who were evaluated for primary disease evaluation . ▪ 15 percent achieved a partial response. ▪ At the time of the interim analysis presentation, of the 20 patients who achieved a CR, 13 patients had reached three-month follow-up, and all remained in CR. Four of these 13 patients had reached six-month follow-up and one of the 13 patients had reached nine-month follow-up, and all remained in CR. o Top-line results from the OLYMPUS trial are expected in..." |
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| 08/08/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 06/06/2018 |
6-K
| Quarterly results |
| 06/06/2018 |
6-K
| Quarterly results |
| 05/15/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"FORM 6-K",
"Unaudited Condensed Consolidated Interim Balance Sheets as of March 31, 2018 and December 31, 2017, and Unaudited Condensed Consolidated Interim Statements of Operations, Statements of Changes in Shareholders’ Equity and Statements of Cash Flows for the three months ended March 31, 2018 and March 31, 2017",
"UROGEN PHARMA LTD. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS",
"Clinical Development Progress of UGN-101 : o The Company will present an interim analysis from the OLYMPUS pivotal trial of UGN-101 in patients with LG UTUC on Monday, May 21, 2018 during the Plenary Session of the 113 th AUA Annual Meeting in San Francisco, CA. ▪ Presentation details and the full text for the abstract are available online through the Journal of Urology website. o Top-line results from the completed OLYMPUS trial are expected in 2H 2018, with the Company planning to submit an NDA in Q1 2019 to the FDA for UGN-101 for the treatment of LG UTUC. Potential approval and commercial launch of UGN-101 in the United States is targeted for 2H 2019. • Advancing the Pipeline and Potential for the RTGel™ Platform: o UGN-102 : The Company intends to submit an IND Appl..." |
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| 04/25/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 04/04/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 02/20/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 01/11/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 01/08/2018 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 12/14/2017 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"FORM 6-K",
"UroGen Pharma Expands Clinical Development Leadership Team Mark Schoenberg, M.D., Named Chief Medical Officer Elyse Seltzer, M.D., Appointed Senior Vice President of Clinical Development Ra'anana, Israel, and , December 12, 2017: UroGen Pharma Ltd. , a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that Mark Schoenberg, M.D., has been named Chief Medical Officer of UroGen, having previously served the Company as Medical Director. In addition, the Company announced the appointment of Elyse Seltzer, M.D., as UroGen's Senior Vice President of Clinical Development. “We are thrilled to announce the expansion of our world-class drug development team with the appointment of Mark as CMO an..." |
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| 11/14/2017 |
6-K
| Quarterly results |
| 11/07/2017 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"6-K",
"UroGen Pharma Announces First Patient Enrolled in Allergan Phase 2 Clinical Trial of RTGel™ in Combination with BOTOX ® for the Treatment of Overactive Bladder Ra'anana, Israel and , November 6, 2017: UroGen Pharma Ltd. , a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced the enrollment of the first patient in a Phase 2 clinical trial of RTGel™ in combination with BOTOX ® for the treatment of overactive bladder. The Phase 2 trial is being conducted by Allergan Pharmaceuticals International Limited, or Allergan, a wholly owned subsidiary of Allergan plc, under the terms of a license agreement with UroGen Pharma. RTGel™ is UroGen Pharma's proprietary sustained release, hydrogel-based formulation technology designed..." |
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| 11/02/2017 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"FORM 6-K",
"UroGen Pharma Appoints Former Kite Pharma Chief Operating Officer Cynthia M. Butitta to its Board of Directors Ra'anana, Israel, and , November 2, 2017: UroGen Pharma Ltd. , a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced the appointment of Cynthia M. Butitta to its board of directors, effective immediately. Ms. Butitta is a seasoned financial and operational executive with over 25 years of leadership experience in both the biotechnology and high-technology industries. Most recently, Ms. Butitta served as Chief Operating Officer of Kite Pharma, where she played an instrumental role leading up to Kite Pharma's acquisition by Gilead Sciences for approximately $11.9 billion in cash. ..." |
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| 08/29/2017 |
6-K
| Quarterly results |
| 08/14/2017 |
6-K
| Quarterly results |
| 07/19/2017 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
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