Urogen (URGN) Upgrade Fails to Impress 21%

Many cancers remain difficult to treat and bladder cancer is no exception. Urogen Pharma developed two formulations of the drug mitomycin, UGN-101 and UGN-102, to tackle two distinct forms of the disease. Both drugs demonstrated strong clinical results in 2018. SanaCurrents assigned a superior sentiment in February 2019 that Urogen would report more positive data in both drugs later in the year.

UGN-102 was developed to treat low grade, non-muscle invasive bladder cancer (LG-NMIBC), which is a larger indication than the disease targeted by UGN-101. As expected, Urogen reported a 63% complete response (CR) rate in interim phase IIb results for UGN-102. The 63% CR rate signaled UGN-102 could be a viable, less invasive treatment option for LG-NMIBC patients instead of repetitive surgical intervention.

Yet during 2019 Urogen’s shares fell as investors came to question whether UGN-101 and UGN-102, regardless of clinical merit, would be embraced by practicing urologists who primarily treat bladder cancer by surgery. Most bladder cancer patients also are age 65 to 75 when they are treated.

At the time of the SanaCurrents report, Urogen traded at $41.34 per share. The interim results from UGN-102 failed to impress and Urogen’s shares closed on September 24, 2019, at $32.65, reflecting a decline of 21% from February.

Urogen subsequently gained approval for UGN-101 under the brand name Jelymto. In updated data for UGN-102, Urogen reported 65% of the patients in the trial achieved a complete response three months after the start of therapy.

Now that Urogen is commercializing UGN-101, the company is launching a strategy to give urologists the chance to switch to a new therapy without losing revenue for the practice.