Friday , February 26 2021

UroGen Reported Third Quarter Financial Results



UroGen Pharma Ltd. (NASDAQ: URGN), a clinical biopharmaceutical company that develops treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced financial results for the third quarter ending September 30 2018 and has completed the UGN-101 registration OLYMPUS Phase 3 trial on patients with upper urinary tract cancer (LG UTUC) after the Pre-New Drug Application (NDA) meeting was recently held with the US Food and Drug Administration (FDA).

"We are pleased with the FDA's support for the UGN-101 and the recognition of the potential clinical benefits provided by the UGN-101 for LG UTUC as a non-invasive therapy with potential organ-sparing for this disease," said Ron Bentsur, Chief Executive Officer of UroGen. "We are very pleased with the progress we continue to make along our clinical pathway and hope to collaborate with the FDA to bring this potential transformative therapy to patients with LG UTUC." Determination of Breakthrough Therapy (BTD) was given by the FDA for UGN1 -101 for treatment LG UTUC in October 2018. UroGen remains on track to start UGN-101 Rolling NDA Submission to the FDA in Q4 2018 and complete submission in Q2 2019, with potential approval expected in 2019.

The research and development costs for the nine months ended September 30, 2018 were $ 25.5 million, including a non-cash based compensation fee of $ 9.1 million. The research and development costs for the three months ended September 30, 2018 were $ 9.6 million, including a non-cash based compensation fee of $ 3.8 million. General and administrative expenses for the nine months ended September 30, 2018 were $ 27.0 million, including non-cash based compensation costs of $ 12.7 million. General and administrative costs for the three months ended September 30, 2018 were $ 10.7 million, including non-cash based compensation costs of $ 5.7 million.


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