Home Biotech Insights UroGen Pharma Receives Expedited FDA Approval for Cancer Treatment

UroGen Pharma Receives Expedited FDA Approval for Cancer Treatment


UroGen Pharma (NASDAQ: URGN) a biopharmaceutical company focused on the treatment of specialty cancers and urologic diseases, announced that it received approval from the U.S. Food and Drug Administration (FDA) for its Jelmyto cancer treatment. Jelmyto is used for patients with low-grade upper tract urothelial cancer (UTUC), the world’s ninth most common cancer.

The FDA conducted the evaluation of Jelmyto under its Priority Review process for medications that may represent significant improvements in the treatment of serious conditions. It designated Jelmyto as a Breakthrough Therapy which serves to expedite the review of drugs that are being developed to address life-threatening diseases with a high unmet need.

UroGen Pharma 8-K SEC Filing

Innovative technology delivers non-invasive chemotherapy

The FDA approval was based on UroGen’s recent phase three OLYMPUS trial results that indicated Jelmyto was an effective solution for UTUC cancer patients. The recently concluded trial at the Baylor College of Medicine in Houston showed a complete response rate of 58% in patients for whom surgery was not an option.

Jelmyto contains a well-known chemotherapy called mitomycin along with a sterile hydrogel that uses the company’s proprietary sustained release RTGel technology. It is designed to expose urinary tract tissue to chemotherapy for a longer duration and eliminate the need to treat tumors through surgical procedures.

Transforming the treatment of UTUC cancer

The treatment of low-grade UTUC is difficult because of the complex nature of the human urinary tract system. Current treatment options are limited to multiple surgeries that often involve the removal of a patient’s renal pelvis, kidney, ureter, and bladder cuff which can lead to high rates of relapse. Moreover, since most patients are typically over 70 years old and often have existing kidney malfunctions, major surgery can become even more complicated. UroGen’s novel, minimally invasive Jelmyto medication has the potential to revolutionize the way UTUC cancer is treated.

President and CEO Liz Barrett commented, “UroGen was founded on the vision to improve lives by challenging the current standard of care. Jelmyto, which leverages our innovative technology and expertise in specialty cancers and urologic diseases, is just the beginning as we build a company focused on brining novel solutions to patients.”

Looking ahead

Urothelial cancer is the eight most fatal cancer amongst U.S. males. There are 6,000 to 7,000 new cases annually. As the first non-surgical treatment for UTUC, the announcement was encouraging news for patients that suffer from the hard to treat cancer. The FDA approval marked a pivotal step in the validation of UroGen’s technology and the future growth opportunities that lie ahead for the specialty cancer company.

Investors have also reacted favorably to the announcement as shares of UroGen have advanced more than 10% since the Jelmyto FDA approval. The stock has received positive comments from multiple Wall Street analysts in recent days. Three analysts have reiterated buy ratings and posted bullish target prices for UroGen in the range of $46 to $57. Additional information on the company’s product pipeline and financial results are expected in its quarterly report scheduled for May 15th.
UroGen Pharma 8-K SEC Filing


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