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[8-K] UroGen Pharma Ltd. Reports Material Event

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

UroGen Pharma reported that it has entered a settlement and license agreement with Teva Pharmaceuticals resolving patent litigation over Jelmyto, its mitomycin-based treatment for upper tract urothelial cancer. Teva had filed an Abbreviated New Drug Application seeking to market a generic Jelmyto before UroGen’s patents expired.

Under the agreement, UroGen will grant Teva a non-exclusive license to sell a generic version of Jelmyto in the United States starting on September 15, 2030, if it receives U.S. Food and Drug Administration approval and subject to certain customary conditions. All related patent cases in the U.S. District Court for the District of Delaware will be terminated, and the agreement will be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice.

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Insights

UroGen sets a defined U.S. generic entry date for Jelmyto via Teva settlement.

UroGen Pharma and Teva have agreed to end their Jelmyto patent dispute by granting Teva a non-exclusive license to market a generic version from September 15, 2030, assuming U.S. FDA approval and typical conditions. This replaces litigation uncertainty with a contractually defined entry point.

The arrangement indicates Jelmyto remains protected from Teva’s generic competition until that date, while still depending on FDA approval for Teva’s product and antitrust review of the agreement by the U.S. Federal Trade Commission and Department of Justice. Financial terms are not disclosed here, so direct economic impact is not quantified.

Investors can view September 15, 2030 as the agreed earliest date for Teva’s generic Jelmyto launch under this agreement. Subsequent company filings may provide more detail on how this timing interacts with remaining patent life, other potential generic challengers, and Jelmyto’s sales trajectory.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
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Understanding 8-K Material Events →
false 0001668243 0001668243 2026-06-02 2026-06-02
 
 
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 8-K
 
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): June 2, 2026
 
UROGEN PHARMA LTD.
(Exact name of registrant as specified in its charter)
 
 
Israel
001-38079
98-1460746
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
 
400 Alexander Park Drive, 4th Floor
Princeton, New Jersey
  
08540
(Address of principal executive offices)
  
(Zip Code)
 
Registrant’s telephone number, including area code: +1 (646) 768-9780
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
 
☐         Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐         Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐         Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐         Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
  
Trading
Symbol(s)
  
Name of each exchange
on which registered
Ordinary Shares, par value NIS 0.01 per share
  
URGN
  
The Nasdaq Stock Market LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 
 
 
 
Item 8.01         Other Events.
 
On June 2, 2026, UroGen Pharma Ltd. and UroGen Pharma Inc. (collectively, “the Company”) issued a press release announcing that the Company entered into a settlement and license agreement (the “Agreement”) with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (collectively, “Teva”) that resolves the patent litigation between the parties related to Jelmyto® (mitomycin) for pyelocalyceal solution.
 
The patent litigation resulted from Teva’s submission of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture, use or sell a generic version of Jelmyto in the United States prior to the expiration of relevant Company patents. Under the terms of the Agreement, the Company will grant Teva a non-exclusive license to sell Teva’s generic version of Jelmyto beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing patent litigation between the Company and Teva regarding Jelmyto patents pending in the U.S. District Court for the District of Delaware.
 
The Agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: June 2, 2026
UROGEN PHARMA LTD.
  
       
       
 
By:
/s/ Chris Degnan
  
   
Chris Degnan
  
   
Chief Financial Officer
  
 
 

Source: View Original Filing on SEC EDGAR

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