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

Wed, 03 Jun 2026 06:53:09 -0400

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

Oppenheimer on UroGen Pharma (URGN): 'We expect Zusduri's continued launch to drive outperformance'

Tue, 02 Jun 2026 13:10:24 -0400

Oppenheimer analyst Leland Gershell reiterated an Outperform rating and $40.00 price target on UroGen Pharma (NASDAQ: URGN).

The analyst comments "We view UroGen's announcement that it had settled with sole Jelmyto generic challenger TEVA as a modest positive. Zusduri remains the key investor focus given its much larger market opportunity and early launch progress, but the settlement reduces uncertainty around Jelmyto's contribution (~$100M/yearr) to URGN's top line over the next ~four years—with the protected period being just ~four months short of RT gel products' January 2031 key patent expiry. There remains no generic challenger to Zusduri, and we remind investors that

Form 8-K UroGen Pharma Ltd. For: Jun 02

Tue, 02 Jun 2026 08:05:00 -0400

si-local-file:///var/storage/secattach/20260602/26587884.html

Form 8-K UroGen Pharma Ltd. For: Jun 02

Tue, 02 Jun 2026 08:05:00 -0400

si-local-file:///var/storage/secattach/20260602/26587884.html

UroGen settles JELMYTO patent litigation with Teva

Tue, 02 Jun 2026 08:00:46 -0400

UroGen Pharma Ltd. (NASDAQ: URGN) announced a settlement agreement with Teva Pharmaceuticals resolving patent litigation related to JELMYTO (mitomycin) for pyelocalyceal solution. The agreement grants Teva a non-exclusive license to sell its generic version of JELMYTO beginning September 15, 2030, if approved by the FDA.

The litigation began after Teva submitted an Abbreviated New Drug Application seeking approval to market a generic version of JELMYTO before UroGen's relevant patents expire. According to the FDA's public database, Teva's application has not received tentative approval.

Under the settlement terms, both parties will ask the court to dismiss the pending patent litigation with prejudice. The

UroGen settles JELMYTO patent litigation with Teva

Tue, 02 Jun 2026 08:00:46 -0400

Under the settlement terms, both parties will ask the court to dismiss the pending patent litigation with prejudice. The

UroGen Announces Agreement Resolving Patent Litigation Relating to JELMYTO® (mitomycin) for pyelocalyceal solution

Tue, 02 Jun 2026 08:00:00 -0400

Agreement reinforces the value of UroGen’s innovation and reflects the strength of the Company’s intellectual property portfolio
Teva will be granted a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA

PRINCETON, N.J., June 02, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has entered into a settlement and license agreement (the “Agreement”’) with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals, USA, Inc. (collectively,

UroGen Announces Agreement Resolving Patent Litigation Relating to JELMYTO® (mitomycin) for pyelocalyceal solution

Tue, 02 Jun 2026 08:00:00 -0400

Agreement reinforces the value of UroGen’s innovation and reflects the strength of the Company’s intellectual property portfolio
Teva will be granted a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA

UroGen Pharma to Present at the Goldman Sachs 47th Annual Global Healthcare Conference

Mon, 01 Jun 2026 16:10:00 -0400

PRINCETON, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced that management will present at the Goldman Sachs 47^th Annual Global Healthcare Conference to take place on June 8-10, 2026.

Goldman Sachs 47^th Annual Global Healthcare Conference

Date / Time:	June 10, 2026, at 8:40 AM ET
Format:	Fireside chat and 1x1 investor meetings
Location:
Date / Time:	June 10, 2026, at 8:40 AM ET
Format:	Fireside chat and 1x1 investor meetings
Location:	H.C. Wainwright Reiterates Buy Rating on UroGen Pharma (URGN) Mon, 18 May 2026 07:04:10 -0400 H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $45.00 price target on UroGen Pharma (NASDAQ: URGN). The analyst commented: "Last week, UroGen announced a 36-month duration of response (DOR) of 64.5% (95% CI, 54.6% - 72.8%) by Kaplan-Meier estimate in patients who achieved a complete response (CR) at three months (79.6%) in the pivotal Phase 3 ENVISION trial of ZUSDURI (mitomycin) for intravesical solution. At a median follow-up of 35.5 months, the median DOR had not been reached. These data demonstrate that a substantial proportion of complete responders remained disease-free at three years, and durable outcomes were achieved without Form SCHEDULE 13G/A UroGen Pharma Ltd. Filed by: Paradigm Biocapital Advisors LP Fri, 15 May 2026 16:33:00 -0400 si-local-file:///var/storage/secattach/20260515/26506451.html Form SCHEDULE 13G/A UroGen Pharma Ltd. Filed by: Paradigm Biocapital Advisors LP Fri, 15 May 2026 16:33:00 -0400 si-local-file:///var/storage/secattach/20260515/26506451.html Form SCHEDULE 13G UroGen Pharma Ltd. Filed by: TORONTO DOMINION BANK Fri, 15 May 2026 13:46:00 -0400 si-local-file:///var/storage/secattach/20260515/26503450.html Form SCHEDULE 13G UroGen Pharma Ltd. Filed by: TORONTO DOMINION BANK Fri, 15 May 2026 13:46:00 -0400 si-local-file:///var/storage/secattach/20260515/26503450.html UroGen achieves 94.5% six-month response durability in bladder cancer trial Fri, 15 May 2026 08:00:24 -0400 UroGen Pharma Ltd. (NASDAQ: URGN) reported that UGN-103 achieved a 94.5% durability of response at six months in its Phase 3 UTOPIA trial for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The six-month results showed a 95% confidence interval of 86.1% to 97.9% by Kaplan-Meier estimate. These findings align with the 91.9% six-month durability of response observed in the ENVISION trial for ZUSDURI, UroGen's FDA-approved treatment for the same patient population. The UTOPIA trial is a single-arm, multicenter study evaluating 99 patients across global sites. Patients received 75 mg of UGN-103 via intravesical instillation once weekly for six weeks in UroGen achieves 94.5% six-month response durability in bladder cancer trial Fri, 15 May 2026 08:00:24 -0400 UroGen Pharma Ltd. (NASDAQ: URGN) reported that UGN-103 achieved a 94.5% durability of response at six months in its Phase 3 UTOPIA trial for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The six-month results showed a 95% confidence interval of 86.1% to 97.9% by Kaplan-Meier estimate. These findings align with the 91.9% six-month durability of response observed in the ENVISION trial for ZUSDURI, UroGen's FDA-approved treatment for the same patient population. The UTOPIA trial is a single-arm, multicenter study evaluating 99 patients across global sites. Patients received 75 mg of UGN-103 via intravesical instillation once weekly for six weeks in UroGen achieves 94.5% six-month response durability in bladder cancer trial Fri, 15 May 2026 08:00:24 -0400 UroGen Pharma Ltd. (NASDAQ: URGN) reported that UGN-103 achieved a 94.5% durability of response at six months in its Phase 3 UTOPIA trial for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The six-month results showed a 95% confidence interval of 86.1% to 97.9% by Kaplan-Meier estimate. These findings align with the 91.9% six-month durability of response observed in the ENVISION trial for ZUSDURI, UroGen's FDA-approved treatment for the same patient population. The UTOPIA trial is a single-arm, multicenter study evaluating 99 patients across global sites. Patients received 75 mg of UGN-103 via intravesical instillation once weekly for six weeks in UroGen achieves 94.5% six-month response durability in bladder cancer trial Fri, 15 May 2026 08:00:24 -0400 UroGen Pharma Ltd. (NASDAQ: URGN) reported that UGN-103 achieved a 94.5% durability of response at six months in its Phase 3 UTOPIA trial for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The six-month results showed a 95% confidence interval of 86.1% to 97.9% by Kaplan-Meier estimate. These findings align with the 91.9% six-month durability of response observed in the ENVISION trial for ZUSDURI, UroGen's FDA-approved treatment for the same patient population. The UTOPIA trial is a single-arm, multicenter study evaluating 99 patients across global sites. Patients received 75 mg of UGN-103 via intravesical instillation once weekly for six weeks in UroGen achieves 94.5% six-month response durability in bladder cancer trial Fri, 15 May 2026 08:00:24 -0400 UroGen Pharma Ltd. (NASDAQ: URGN) reported that UGN-103 achieved a 94.5% durability of response at six months in its Phase 3 UTOPIA trial for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The six-month results showed a 95% confidence interval of 86.1% to 97.9% by Kaplan-Meier estimate. These findings align with the 91.9% six-month durability of response observed in the ENVISION trial for ZUSDURI, UroGen's FDA-approved treatment for the same patient population. The UTOPIA trial is a single-arm, multicenter study evaluating 99 patients across global sites. Patients received 75 mg of UGN-103 via intravesical instillation once weekly for six weeks in

StreetInsider.com News Articles

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

Oppenheimer on UroGen Pharma (URGN): 'We expect Zusduri's continued launch to drive outperformance'

Form 8-K UroGen Pharma Ltd. For: Jun 02

Form 8-K UroGen Pharma Ltd. For: Jun 02

UroGen settles JELMYTO patent litigation with Teva

UroGen settles JELMYTO patent litigation with Teva

UroGen Announces Agreement Resolving Patent Litigation Relating to JELMYTO® (mitomycin) for pyelocalyceal solution

UroGen Announces Agreement Resolving Patent Litigation Relating to JELMYTO® (mitomycin) for pyelocalyceal solution

UroGen Pharma to Present at the Goldman Sachs 47th Annual Global Healthcare Conference

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

Form SCHEDULE 13G/A UroGen Pharma Ltd. Filed by: Paradigm Biocapital Advisors LP

Form SCHEDULE 13G/A UroGen Pharma Ltd. Filed by: Paradigm Biocapital Advisors LP

Form SCHEDULE 13G UroGen Pharma Ltd. Filed by: TORONTO DOMINION BANK

Form SCHEDULE 13G UroGen Pharma Ltd. Filed by: TORONTO DOMINION BANK

UroGen achieves 94.5% six-month response durability in bladder cancer trial

UroGen achieves 94.5% six-month response durability in bladder cancer trial

UroGen achieves 94.5% six-month response durability in bladder cancer trial

UroGen achieves 94.5% six-month response durability in bladder cancer trial

UroGen achieves 94.5% six-month response durability in bladder cancer trial