Urogen Pharma Ltd
NASDAQ:URGN
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Urogen Pharma Ltd
UroGen Pharma Ltd. is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases. The firm is engaged in building solutions for cancers and urologic diseases. UroGen has developed RTGelTM reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. Its lead product candidates include MitoGel and VesiGel are formulated using its proprietary reverse thermally triggered hydrogel, or RTGel, technology. MiroGel ( UGN-101) is a sustained release formulation of the chemotherapy agent Mitomycin C for the treatment of low-grade upper tract urothelial carcinoma, an urothelial cancer in the upper tract. VesiGel (UGN-102) is a sustained release formulation of a high dose Mitomycin C for the treatment of low grade non-muscle invasive bladder cancer (LG-NMIBC).
UroGen Pharma Ltd. is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases. The firm is engaged in building solutions for cancers and urologic diseases. UroGen has developed RTGelTM reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. Its lead product candidates include MitoGel and VesiGel are formulated using its proprietary reverse thermally triggered hydrogel, or RTGel, technology. MiroGel ( UGN-101) is a sustained release formulation of the chemotherapy agent Mitomycin C for the treatment of low-grade upper tract urothelial carcinoma, an urothelial cancer in the upper tract. VesiGel (UGN-102) is a sustained release formulation of a high dose Mitomycin C for the treatment of low grade non-muscle invasive bladder cancer (LG-NMIBC).
ZUSDURI Launch: ZUSDURI launch showed growing demand, with October preliminary revenue more than doubling the prior three months, but broader adoption is delayed by operational hurdles and reimbursement complexities.
JELMYTO Growth: JELMYTO delivered another strong quarter with $25.7 million in sales, representing a 13% increase in underlying demand revenue over the same period in 2024.
Permanent J-code Impact: A permanent J-code for ZUSDURI will go into effect January 1, 2026, which is expected to accelerate adoption, especially in community practices currently reluctant to prescribe.
2025 Guidance: Full-year 2025 JELMYTO revenue guidance was reaffirmed at $94 million to $98 million, implying 8% to 12% growth over 2024.
Clinical Pipeline: UGN-103 and UGN-104 are progressing as planned, with a new drug application for UGN-103 anticipated in the second half of 2026 and potential approval in 2027.
Financial Position: The company ended Q3 2025 with $127.4 million in cash, and management believes current resources are sufficient to reach profitability.
