Urogen Pharma

The company's core technology is RTGel®, a proprietary reverse-thermal hydrogel platform. This technology is liquid at cooler temperatures and becomes a gel at body temperature, a characteristic that allows for the sustained release of active pharmaceutical ingredients directly at the treatment site. This extended exposure is designed to improve the effectiveness of local therapies for urological conditions.

UroGen's business model is centered on the development and commercialization of its proprietary drug delivery systems. Revenue is generated from the sale of its approved products. The company's first major product, Jelmyto® (mitomycin), received FDA approval on April 15, 2020. It is the first approved non-surgical treatment for adults with low-grade upper tract urothelial cancer (LG-UTUC). Jelmyto utilizes the RTGel® technology to deliver mitomycin, an established chemotherapy agent, directly to the pyelocalyceal system. For the full year 2024, Jelmyto generated net product revenue of $90.4 million.

Expanding its commercial portfolio, UroGen recently gained FDA approval for ZUSDURI™ (mitomycin) for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The company's pipeline includes several candidates in various stages of clinical development. UGN-102 is an intravesical mitomycin formulation for low-grade intermediate-risk NMIBC. Additionally, the company is advancing next-generation formulations like UGN-103 and UGN-104 through partnerships and has an immuno-oncology candidate, UGN-301, in Phase 1 trials.

UroGen Pharma was founded by Asher Holtzer and is led by CEO & President Liz Barrett and Chairman of the Board Arie Belldegrun, M.D. The company became publicly listed on the NASDAQ exchange under the ticker URGN in May 2017.