UroGen Pharma Ltd. — Form 8-K
Filed November 4, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 72/100
What the filing says
UroGen reported Q3 2026 ZUSDURI revenue of $68.0M (35% QoQ growth) with 1,538 activated care sites and 662 prescribers. The FDA accepted the NDA for UGN-103 with PDUFA goal date of June 14, 2027, and a new patent covering non-surgical NMIBC treatment extends exclusivity to July 2044. The company also announced first patient dosed in UGN-501 Phase 1 trial and a strategic collaboration with IntraGel (up to $7M equity investment, $4M deployed in Q3). Company raised 2026 JELMYTO guidance downward to ~$90M from $97–101M due to CMS true-up and competitive trial enrollment pressure.
Why this rating
ZUSDURI scaling strongly ($68M Q3 ≈11% of market cap); UGN-103 NDA acceptance & patent to 2044 reduce pipeline risk materially. JELMYTO revenue miss modest; company cash-positive and near breakeven on net loss. Pipeline advancement offsets near-term JELMYTO headwind.
Price action (we called it positive)
before filing · preread $30.92 | at our read pending | +10 min pending | +30 min pending | +1 hr pending | +4 hrs pending |
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