H.C. Wainwright Reiterates Buy Rating on UroGen Pharma (URGN)

H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $45.00 price target on UroGen Pharma (NASDAQ: URGN).

The analyst commented: "In a press release yesterday, UroGen announced that it has entered into a settlement and license agreement with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals, USA, Inc., part of Teva Pharmaceutical Industries Ltd. (TEVA; not rated), a leading generic medicine manufacturer. This agreement resolves the patent litigation that UroGen initiated in response to Teva’s submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of JELMYTO (mitomycin) for pyelocalyceal solution prior to the expiration of the relevant patents held by UroGen. Investors should note that the Teva ANDA has not received tentative approval from the FDA, according to the agency’s public database. Under the terms of the agreement, UroGen will grant Teva a non-exclusive license to sell its 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. The parties will ask the court to dismiss the pending patent litigation with prejudice. JELMYTO has regulatory exclusivity through April 15, 2027, and is covered by Orange Book-listed patents expiring on January 20, 2031. The negotiated license date preserves nearly all of this patent protection period, reflecting the strength of UroGen’s intellectual property (IP). We note that the settlement reflects only a <10% reduction in the total exclusivity period, which in our view points to the probable lack of confidence that Teva had in ultimately overturning the exclusivity via the litigation process. Also, while no generic filing has yet been submitted on UroGen's other marketed product ZUSDURI, we believe that the resolution of the Teva case on JELMYTO has important implications for any future ZUSDURI generic patent challenge. We do not see any possibility for ZUSDURI generics to enter the market meaningfully ahead of patent expiration in early 2031. UroGen's follow-up to JELMYTO, UGN-104, is currently in a pivotal study that is slated to complete enrollment by the end of this year. UGN-104 could enter the U.S. market by 2029, well ahead of JELMYTO patent expiration, and may extend market exclusivity to the 2041 time frame. We reiterate our Buy rating and 12-month price target of $45."

For an analyst ratings summary and ratings history on UroGen Pharma click here. For more ratings news on UroGen Pharma click here.

Shares of UroGen Pharma closed at $26.54 yesterday.

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