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[{"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":"Cell and Gene therapy","graph2":"Urovant Sciences"},{"orgOrder":0,"company":"UroGen Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"UroGen Provides Update on a Phase 2 Trial of an RTGel\u2122 Hydrogel Formulation and BOTOX\u00ae Combo for Overactive Bladder and Urinary Incontinence","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"UroGen Pharma"},{"orgOrder":0,"company":"Lipella Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipella Pharmaceuticals Initiates Its Phase-2a Clinical Trial of LP-10 for Hemorrhagic Cystitis","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Lipella Pharmaceuticals"},{"orgOrder":0,"company":"Vaneltix Pharma","sponsor":"Hyloris Pharmaceuticals","pharmaFlowCategory":"D","amount":"$6.7 million","upfrontCash":"Undisclosed","newsHeadline":"Hyloris Enters into Strategic Partnership with Vaneltix for Treatment of Acute Pain in Interstitial Cystitis","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Vaneltix Pharma"},{"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":"Cell and Gene therapy","graph2":"Urovant Sciences"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences to Present Interim Data from Phase 2a Study of Potential Novel Gene Therapy, URO-902, and New Analyses of Data from Phase 3 EMPOWUR Extension Trial of GEMTESA\u00ae (vibegron) 75 mg at 2022 American Urological Association Annual Meeting","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Urovant Sciences"},{"orgOrder":0,"company":"Urovant Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Urovant Sciences\u00ae Presents Interim Data from Phase 2a Study of Investigational Novel Gene Therapy, URO-902, Supporting Safety, Tolerability, and Efficacy Endpoints at 2022 American Urological Association Meeting","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Urovant Sciences"},{"orgOrder":0,"company":"Cook MyoSite","sponsor":"Lipella Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Lipella Pharmaceuticals Enters Manufacturing Collaboration Agreement with Cook MyoSite","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Cook MyoSite"},{"orgOrder":0,"company":"Hyloris Pharmaceuticals","sponsor":"Vaneltix Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Hyloris Announces Enrolment of First Patient in a 4-Arm Clinical Trial of Alenura(TM)","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase II","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Hyloris Pharmaceuticals"}]

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            Details:

            Alenura is a unique, combination product of alkalinised lidocaine and the glycosaminoglycan heparin. Alkalinised lidocaine penetrates the transitional epithelial cell layer and provides immediate pain relief.

            Lead Product(s): Lidocaine,Heparin Sodium

            Therapeutic Area: Urology Product Name: Alenura

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Vaneltix Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 22, 2023

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            The collaboration aims to facilitate Chemistry, Manufacturing, and Control documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis. LP-10 has been granted Orphan Drug Designation by the FDA.

            Lead Product(s): Tacrolimus

            Therapeutic Area: Urology Product Name: LP-10

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Lipella Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration April 17, 2023

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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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            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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            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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            Details:

            Under the terms of the agreement, Vaneltix will be responsible for the further development, manufacturing, regulatory affairs and commercialisation of AlenuraTM in collaboration with Hyloris.

            Lead Product(s): Lidocaine,Heparin Sodium

            Therapeutic Area: Urology Product Name: Alenura

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Hyloris Pharmaceuticals

            Deal Size: $6.7 million Upfront Cash: Undisclosed

            Deal Type: Collaboration December 17, 2021

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            Details:

            A multi-site, prospective, open-label, dose-escalation clinical trial assessing the safety and efficacy of LP-10 (liposomal tacrolimus) is now open for recruitment at several sites.

            Lead Product(s): Tacrolimus

            Therapeutic Area: Urology Product Name: LP-10

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 15, 2020

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            Details:

            Phase 2 APOLLO clinical trial of a RTGel hydrogel formulation in combination with BOTOX® intravesical instillation in patients with overactive bladder (OAB) and urinary incontinence did not meet the primary endpoint of improvement of overactive bladder symptoms.

            Lead Product(s): OnabotulinumtoxinA

            Therapeutic Area: Urology Product Name: Botox

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 27, 2020

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            Details:

            In the trials, URO-902 was well tolerated and the administration via direct injection procedure demonstrated statistically significant improvement in OAB symptoms.

            Lead Product(s): URO-902

            Therapeutic Area: Urology Product Name: Undisclosed

            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 February 04, 2020

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