RegulatoryCompany release

UroGen's ZUSDURI Revenue Hits $68M in Q3 as FDA Accepts UGN-103 NDA

🇺🇸 UroGen Pharma Ltd. (URGN) · Wed 04 Nov 2026

UroGen reported a 35% quarter-on-quarter rise in ZUSDURI net revenue, a narrower loss, and a June 2027 FDA goal date for UGN-103 in low-grade bladder cancer.

UroGen Pharma reported third-quarter 2026 results on 4 November, with net revenue from ZUSDURI (mitomycin) of $68.0 million. The company said this was 35% higher than in the previous quarter. Its net loss for the period narrowed to $1.5 million.

On the regulatory side, the US Food and Drug Administration has accepted UroGen's new drug application for UGN-103. The product is aimed at recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of 14 June 2027.

As general context, a PDUFA date is the target by which the FDA aims to complete its review of an application. It is not a guarantee of approval.

UroGen also said the first patient has been dosed in the Phase 1 trial of UGN-501. The summary provided does not give further detail on the trial design or the indication.

What it means for your team

  • Regulatory teams tracking bladder cancer filings can note the 14 June 2027 PDUFA date for UGN-103 in recurrent low-grade intermediate-risk NMIBC.
  • Market-access teams can read the $68.0 million in ZUSDURI net revenue, up 35% on the prior quarter, as an early indicator of uptake of the product.
  • UroGen's pipeline now includes an early-stage programme, UGN-501, with its Phase 1 trial under way.

Company's press release (SEC filing): UroGen Pharma Ltd. ↗

Article written by VigiEye from the official source (UroGen Pharma Ltd.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →