UroGen Posts $15.8M ZUSDURI Sales, $94M JELMYTO Revenue and $200M Loan Refinancing

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UroGen's ZUSDURI launch generated $15.8M in 2025 net sales at 838 sites, aided by J9282 reimbursement effective January 1, 2026, while JELMYTO sales grew 7% to $94M. The company refinanced its term loan with a $200M tranche and plans a UGN-103 NDA submission in H2 2026.

1. ZUSDURI Launch and Uptake

UroGen achieved $15.8 million in ZUSDURI net sales during its initial commercial launch period in 2025. As of December 31, 2025, the therapy is supported at 838 activated sites with 102 unique prescribers and benefits from the permanent J9282 buy-and-bill code effective January 1, 2026, to streamline reimbursement.

2. JELMYTO Sales Performance

JELMYTO generated $94.0 million in net product sales in 2025, up from $90.4 million in 2024, reflecting 7% underlying demand growth. This performance underscores continued adoption in low-grade upper tract urothelial cancer following prior CREATES Act contributions.

3. Loan Refinancing Strengthens Balance Sheet

On February 26, 2026, UroGen closed a $200 million tranche under an amended term loan agreement with Pharmakon Advisors, refinancing its existing $125 million facility and securing a non-dilutive capital infusion. A second $50 million tranche remains available through June 30, 2027, under customary conditions.

4. Next-Generation Pipeline Progress

The Phase 3 UTOPIA trial of UGN-103 demonstrated a 77.8% three-month complete response rate, with an NDA submission planned for the second half of 2026 and potential approval in 2027. UroGen is also progressing UGN-104 enrollment (targeting completion by end-2026) and advancing IND-enabling studies for UGN-501 toward a Phase 1 trial by year-end.

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