Urogen Pharma, Inc.

UGN-102 chemoablation showed 79.6% complete response (CR) in Phase 3 study for recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer, with 82.3% disease-free rate at 1 year. Adverse events were generally mild/moderate, supporting UGN-102 as a non-surgical alternative.

FDA accepts UGN-102 (mitomycin) NDA for low-grade intermediate-risk non-muscle-invasive bladder cancer, potentially making it the first approved agent for this patient population. The PDUFA goal date is June 13, 2025. UGN-102, a sustained-release hydrogel formulation, aims to provide a novel treatment option without surgery, supported by phase 3 ENVISION trial data showing a 79.6% complete response rate at three months.

FDA accepted UGN-102 (mitomycin) NDA for low-grade intermediate-risk non-muscle invasive bladder cancer, with a goal date of June 13, 2025. ENVISION trial data showed 79.6% CR rate at 3 months and 82.3% DOR at 12 months, supporting the application.

The FDA accepted UroGen Pharma's NDA for UGN-102, an investigational drug for low-grade, intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC), supported by the phase 3 ENVISION trial. The PDUFA target action date is June 13, 2025. UGN-102 could be the first FDA-approved medicine for LG-IR-NMIBC, offering a novel treatment approach.

UroGen Pharma's NDA for UGN-102 (mitomycin) for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) has been accepted by the FDA. UGN-102, using RTGel technology, aims to prolong bladder tissue exposure to mitomycin for non-surgical tumor treatment. The NDA is supported by clinical trial data showing a 79.6% complete response rate and an 82.3% 12-month duration of response. The FDA decision is expected by June 13, 2025.

UroGen Pharma announced FDA acceptance of its NDA for UGN-102, an investigational drug for LG-IR-NMIBC, with a PDUFA goal date of June 13, 2025. If approved, UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, supported by a 79.6% complete response rate at three months in the ENVISION trial.

UroGen Pharma's UGN-102, a drug for low-grade intermediate-risk non-muscle invasive bladder cancer, received FDA approval. With a 79.6% complete response rate in trials, it may be the first FDA-approved treatment for this condition, potentially launching in 2025.

UroGen Pharma initiated Phase III UTOPIA trial for UGN-103 (mitomycin) to treat low-grade intermediate-risk non-muscle invasive bladder cancer, aiming to enroll 87 subjects. The trial assesses efficacy via complete response rate at three months post-treatment, with follow-up every three months to monitor response.

The first patient has been dosed in the phase 3 UTOPIA trial exploring UGN-103, a mitomycin-based formulation for low-grade, intermediate-risk non–muscle-invasive bladder cancer. The trial aims to enroll 87 patients, who will receive 75 mg of UGN-103 weekly for 6 weeks, with complete response assessed at 3 months. Primary completion is anticipated for March 2025.

UroGen Pharma Ltd. secured a $25 million Tranche C Loan to support corporate needs, with terms contingent on FDA approval of UGN-102 by June 2025. The company also completed its NDA for UGN-102, reported a 16% sequential increase in net product revenue, and secured a patent for RTGel® technology. Despite a negative P/E ratio, UroGen maintains a strong gross profit margin and cash position.