05:04 PM EDT, 10/15/2024 (MT Newswires) -- UroGen Pharma ( URGN ) said Tuesday the US Food and Drug Administration accepted the new drug application for UGN-102 as an intravesical solution to treat low-grade intermediate-risk non-muscle invasive bladder cancer.

The FDA has set a Prescription Drug User Fee Act target action date of June 13, 2025, the company said.

The application is backed by data from three clinical studies that show durability of response and a favorable safety profile, according to UroGen.

Price: 12.10, Change: -0.16, Percent Change: -1.31