UROGEN PHARMA LTD

UGN-102 showed 82.3% DOR at 12 months in patients with complete response at 3 months, and 79.6% CR rate at 3 months. Safety profile consistent with prior trials. Presented at SUO annual meeting in Dallas.

UroGen Pharma announces Q3 2024 financial results, including $25.2M in JELMYTO net product sales. The FDA accepted the New Drug Application for UGN-102 with a PDUFA target action date of June 13, 2025. UroGen reported $254.2M in cash, cash equivalents, and marketable securities as of September 30, 2024. A conference call and webcast will be held on November 6, 2024, at 10:00 AM ET.

Intravesical mitomycin (UGN-102) in phase 3 ENVISION trial showed 82.3% 12-month duration of response for low-grade intermediate-risk non–muscle-invasive bladder cancer patients achieving complete response at 3 months. FDA accepted the new drug application with a target action date of June 13, 2025.

UGN-102 showed 82.3% 12-month DOR in LG-IR-NMIBC patients with 3-month CR, with a 79.6% CR rate at 3 months. Side effects were consistent with previous trials. UroGen submitted an NDA for UGN-102 to the FDA with a PDUFA goal date of June 13, 2025.

UroGen announces FDA acceptance of NDA for UGN-102, aiming to treat LG-IR-NMIBC. PDUFA goal date set for June 13, 2025.