Highest-materiality recent filing
UroGen settles patent litigation with Teva over Jelmyto; generic entry Sept 15, 2030
Settlement resolves patent litigation regarding Teva's generic version of Jelmyto (mitomycin) for pyelocalyceal solution.
UroGen Q1 2026: ZUSDURI revenue $29.2M (+109% QoQ); net loss narrows to $0.47/share
Total revenue $51.0M, up 152% YoY on ZUSDURI launch and JELMYTO growth.
UroGen Pharma secures up to $250M loan at 8.25%; $200M funded to refinance existing debt
Tranche A of $200M funded on Feb 26, used to refinance $125M existing term loan and fund working capital.
UroGen reports FY2025 net loss $153.5M; ZUSDURI launch net sales $15.8M; refinances debt at 8.25%
FY2025 revenue $109.8M (+21% YoY); JELMYTO net sales $94M (underlying demand +7%).
UroGen Q3: ZUSDURI rev $1.8M, Oct estimate $4.5M; JELMYTO +13% YoY; net loss $33.3M
ZUSDURI achieved net product revenue of $1.8M in Q3; October 2025 preliminary demand revenue estimate of $4.5M, with 592 activated sites and 54 prescribers since July launch.
UroGen shareholders approve 2.75M share increase under 2017 equity plan and new compensation policy
Shareholders approved amendment to 2017 Equity Incentive Plan, authorizing 2,750,000 additional ordinary shares.
UroGen reports Q2 loss of $49.9M; launches ZUSDURI after June FDA approval
ZUSDURI (mitomycin) FDA-approved June 12 for recurrent LG-IR-NMIBC; now commercially available.
UroGen awards special bonuses totaling $845K to CEO, CFO, GC for ZUSDURI FDA approval
CEO Elizabeth Barrett receives $645,000; CFO Chris Degnan and GC Jason Smith each get $100,000.
FDA approves UroGen Pharma's ZUSDURI (mitomycin) for recurrent LG-IR-NMIBC
FDA approved ZUSDURI (mitomycin) for adults with recurrent low-grade intermediate-risk NMIBC on June 12, 2025.
UroGen Pharma Q1 2025: JELMYTO revenue $20.3M, net loss widens to $43.8M; UGN-102 PDUFA June 13
JELMYTO net sales $20.3M (+8% YoY); underlying demand grew 12%.
UroGen reports Q4/FY2024: JELMYTO rev $90.4M; net loss $126.9M; guides FY2025 rev $94-98M
UGN-102 NDA under FDA review; PDUFA June 13, 2025; 18-month DOR 80.6% in Phase 3 ENVISION trial.
UroGen acquires ICVB-1042 assets from IconOVir for shares, milestone, and royalties
UroGen issued 374,843 ordinary shares (worth $4.0M) to IconOVir as upfront consideration.
UroGen Pharma furnishes January 2025 corporate presentation; no material new disclosures
Presentation reiterates UGN-102 PDUFA target date of June 13, 2025 and planned ODAC meeting.
UroGen Q3 revenue $25.2M, net loss $23.7M; UGN-102 PDUFA June 2025; cuts FY revenue view
JELMYTO Q3 net product revenue $25.2M (+21% YoY from $20.9M).
UroGen Pharma appoints Christopher Degnan as CFO; Don Kim resigns effectively Oct 8, 2024
Don Kim resigned as CFO, principal financial and accounting officer effective Oct 8, 2024; will provide part-time consulting through Apr 28, 2025 for $36,260.
UroGen Pharma draws $25M Tranche C loan under credit facility
Received $25M third tranche loan on Sept 23, 2024; proceeds for general corporate and working capital needs.
Director Fred E. Cohen resigns from UroGen Pharma board effective immediately
Fred E. Cohen resigned as director on Sept 12, 2024.
UroGen Pharma submits NDA to FDA for UGN-102 for low-grade intermediate-risk NMIBC
Completed NDA submission for UGN-102 to the U.S. FDA.
UroGen ahead of schedule completing UGN-102 NDA; Q2 revenue $21.8M, net loss $33.4M
UGN-102 NDA completion imminent; potential FDA decision as early as Q1 2025 assuming priority review.
All eight director nominees elected with over 24M votes for each; broker non-votes 6.75M.
UroGen Pharma prices $107.5M public offering of 5M shares at $17.50, plus pre-funded warrants
Offering: 5,000,000 ordinary shares at $17.50/share plus 1,142,857 pre-funded warrants at $17.499 each.
UroGen reports positive DOR data from Phase 3 ENVISION trial for UGN-102 in bladder cancer
12-month DOR KM estimate for CR patients: 82.3% (95% CI: 75.9%-87.1%); predicted median DOR of 40 months.
UroGen Q1 net loss $32.3M; JELMYTO revenue up 10% to $18.8M; UGN-102 NDA on track
Net loss $32.3M ($0.97/share) vs $30.2M ($1.30) in Q1 2023; JELMYTO revenue $18.8M, +10% YoY.
UroGen Pharma FY2023: JELMYTO revenue $82.7M (+28% YoY), net loss narrows, UGN-102 NDA on track
Full year JELMYTO net revenue $82.7M, up ~28% YoY from $64.4M; Q4 revenue $23.5M (+30% YoY).
UroGen presents at TD Cowen conference; no material updates provided
Presentation furnished as Exhibit 99.1 for TD Cowen 44th Annual Health Care Conference on March 4, 2024.
UroGen receives Teva Paragraph IV notice challenging two Jelmyto patents expiring 2031
Teva filed ANDA seeking FDA approval for a generic version of Jelmyto (mitomycin) for pyelocaliceal solution.
pursuant to which Mr. Kim resigned from his positions as the Company’s Chief Financial Officer, principal financial officer and principal accounting officer, effective October 8, 2024
the Company appointed Christopher Degnan as the Company’s Chief Financial Officer, principal financial officer and principal accounting officer, effective on the Effective Date.
On September 12, 2024, Fred E. Cohen, M.D., D.Phil., notified UroGen Pharma Ltd. (the “Company”) of his resignation as a director of the Company, effective immediately.
Max materiality 0.95 · Median 0.68 · Most common event earnings