UROGEN PHARMA LTD

• The ENVISION trial results, published in the _Journal of Urology_, demonstrate an 82.3% duration of response at 12 months in patients treated with UGN-102 who achieved complete response. • UGN-102 showed a 79.6% complete response rate at three months in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). • UroGen's NDA for UGN-102 has been accepted by the FDA, with a PDUFA goal date of June 13, 2025, potentially offering a non-surgical option for LG-IR-NMIBC.

The FDA has accepted UroGen's New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution, a potential first-in-class treatment.