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[{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Announces Publication of Phase 3 EMPOWUR Trial Results","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Urology","graph2":"Phase III"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Presents Clinical Efficacy & Safety Data on Lead Drug Candidate Vibegron at American Urological Association Annual Meeting","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Urology","graph2":"Phase III"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Announces Results from URO-902 Phase 1 Trials","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Urology","graph2":"Phase II"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Sumitovant Biopharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sumitovant Biopharma Announces Urovant Sciences Collaboration with Sunovion Pharmaceuticals","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"June 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Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Urology","graph2":"Phase III"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension Study","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Urology","graph2":"Phase III"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Announces Topline Data from Phase 2a Study of Vibegron to Treat Irritable Bowel Syndrome Pain","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase II"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences and Sunovion Pharmaceuticals Launch Primary Care Co-Promotion of GEMTESA\u00ae (vibegron) for Patients with Overactive Bladder","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Urology","graph2":"Approved"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Presents Positive Ambulatory Blood Pressure Data on GEMTESA\u00ae (vibegron) 75 mg","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Urology","graph2":"Approved"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Urology","graph2":"Phase II"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Announces Publication of New Review of 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Association Meeting","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Urology","graph2":"Phase II"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences\u00ae Presents New Data from EMPOWUR Study, Advancing Knowledge of the Treatment of Overactive Bladder at the 2022 American Urological Association Meeting","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Urology","graph2":"Approved"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Pierre Fabre","pharmaFlowCategory":"D","amount":"$75.0 million","upfrontCash":"Undisclosed","newsHeadline":"Urovant Sciences and Pierre Fabre M\u00e9dicament Enter into Exclusive License Agreement to Commercialize Vibegron for the Treatment of Overactive Bladder in the European Economic Area, UK, and Switzerland","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Urology","graph2":"Approved"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences Announces Publication of Pharmacokinetic Data on GEMTESA\u00ae (Vibegron 75mg) Administered as an Intact or Crushed Tablet","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Urology","graph2":"Approved"}]

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            GEMTESA (vibegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 27, 2022

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            Urovant Sciences and Pierre Fabre will share responsibility for Gemtesa (vibegron), clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Pierre Fabre

            Deal Size: $75.0 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement July 05, 2022

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            In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA (Vibegron) was safe and well-tolerated. Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 15, 2022

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            Interim 12-week analysis from an ongoing Phase 2a trial of an investigational novel gene therapy product URO-902 (hMaxi-K), showed clinically relevant improvement in the common symptoms of overactive bladder (OAB) compared to placebo.

            Lead Product(s): Hmaxi-K

            Therapeutic Area: Urology Product Name: URO-902

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 13, 2022

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            Post-hoc analysis indicates significant reductions in urgency episodes and micturitions in patients treated with GEMTESA vs. placebo in both types of overactive bladder (OAB).

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 19, 2022

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            Interim 12-week analysis from a Phase 2a trial of the potential gene therapy, URO-902, in women with overactive bladder and urge urinary incontinence will be featured in a late-breaker presentation during plenary session.

            Lead Product(s): Hmaxi-K

            Therapeutic Area: Urology Product Name: URO-902

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 13, 2022

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            The Therapeutics and Clinical Risk Management paper points out that in international phase 3 EMPOWUR trial, treatment with GEMTESA was associated with significant improvements compared with placebo.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 22, 2022

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            URO-902 showed a clinically meaningful and statistically significant effect on a number of relevant outcome measures in OAB including number of micturitions, urgency episodes, and quality of life indicators compared to placebo, 12 weeks post-administration.

            Lead Product(s): Hmaxi-K

            Therapeutic Area: Urology Product Name: URO-902

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 07, 2022

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            New data from dedicated ambulatory blood pressure study of patients with overactive bladder (OAB) showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2021

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            Details:

            The commercial launch of GEMTESA, a beta-3 (β3) adrenergic receptor agonist, was announced in April 2021. EMTESA reduces the bothersome symptoms of OAB by relaxing the detrusor bladder muscle so that the bladder can hold more urine.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2021

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