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In The Spotlight: Urogen Pharma

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Shares of Urogen Pharma Ltd. (URGN) are up nearly 70% year-to-date while the iShares Nasdaq Biotechnology ETF (IBB) index has lost 0.8% during the same period.

Urogen Pharma is a clinical-stage biopharmaceutical company developing advanced nonsurgical treatments to address unmet needs in the field of urology, focusing on uro-oncology.

The Company's drug candidates are based on RTGel, a novel proprietary polymeric biocompatible, reverse thermal gelation hydrogel. With RTGel formulations, a drug's therapeutic concentration in the tissue can be kept for longer duration, according to the Company.

Urogen's lead investigational therapies are UGN-101 (MitoGel) and UGN-102 (VesiGel).

UGN-101, which carries the Orphan Drug and Fast Track designations, is under a phase III trial for the treatment of low-grade Low-Grade Upper Tract Urothelial Carcinoma (UTUC), dubbed OLYMPUS.

Upper tract urothelial cancer, or UTUC, is the cancer affecting the upper urinary tract, which connects the bladder to the kidney and renal pelvis.

In the United States, there are approximately 7,500 new cases of UTUC each year. Of these, about 2,500 cases are low-grade UTUC, according to the Company. The current standard of care for UTUC is said to be complete or partial surgical removal of the involved kidney and upper urinary tract.

The OLYMPUS trial is designed to enroll approximately 70 patients at clinical sites across the United States and Europe. The patients are administered UGN-101 in six weekly instillations via a standard catheter. Four to six weeks following the last instillation, the patients undergo primary disease evaluation, which involves an ureteroscopy and wash cytology, a standard microscopic test of cells washed from the urine or bladder to detect cancer.

The Company presented encouraging results from interim analysis of the ongoing OLYMPUS study on April 3, 2018, sending its shares up nearly 24% that day.

The interim analysis involved 33 patients - with 28 of them having undergone primary disease evaluation. Of the 28 patients, 16 of them have achieved complete response, i.e., complete response (CR) rate was 57%. The primary disease evaluation results of the remaining 5 patients are awaited.

The OLYMPUS study continues to enroll patients, with full interim analysis scheduled to be presented on May 21, 2018 in an oral presentation during the plenary session at the 113th American Urological Association's (AUA) Annual Meeting in San Francisco.
The top-line results from the OLYMPUS study are expected in the third quarter of 2018.

If all goes well as planned, the Company expects to submit the New Drug Application for UGN-101 (MitoGel) to the FDA in Q1 2019.

Next in the pipeline is UGN-102 (VesiGel) for Low-Grade Non-Muscle Invasive Bladder Cancer (NMIBC).

Bladder cancer that is confined to the mucosa (stage Ta, carcinoma in situ) or submucosa (stage T1) is known as nonmuscle invasive bladder cancer, accounting for about 75-85% of bladder cancers, according to NCBI.

A phase IIa study of UGN-102 in patients with Non Muscle Invasive Bladder Cancer, dubbed OPTIMA, conducted in Europe and Israel, has been completed. A phase IIb trial, known as OPTIMA study II, is expected to be initiated in the U.S. soon after getting FDA permission. The Company intends to submit an Investigational New Drug Application with the FDA in this regard this quarter.

Also in the pipeline are:

-- BotuGel, for treatment of overactive bladder, licensed to Allergan. A phase II trial of BotuGel, initiated by Allergan in November 2017, is underway.
-- UGN-201 (Vesimune) for patients with CIS bladder cancer, which has completed phase Ib study.

Key Numbers (As of Dec.2017)

Accumulated deficit: $47.21 million
Cash: $73.0 million

In addition, in January 2018, the Company raised net proceeds of approximately $64 million from an underwritten public offering.

Urogen went public on the Nasdaq Global Market on May 4, 2017, offering its shares at a price of $13 each. The stock touched an all-time high of $65.49 on Wednesday, before closing the day's trading at $63.23, up 5.74%.

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