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for Priority Review the New Drug Application for mirabegron for Oral Suspension and sNDA for Myrbetriq Tablets","therapeuticArea":"Urology","highestDevelopmentStatus":"Preclinical","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Nymox Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NYMOX Announces Submission of New Drug Application (NDA) to the FDA for Fexapotide Triflutate","therapeuticArea":"Urology","highestDevelopmentStatus":"Preclinical","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Nymox Pharmaceutical"},{"orgOrder":0,"company":"Vensica Therapeutics","sponsor":"Merz Therapeutics","pharmaFlowCategory":"D","amount":"$19.0 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Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NYMOX Announces New Marketing Submission for NYMOZARFEX for BPH","therapeuticArea":"Urology","highestDevelopmentStatus":"Preclinical","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Nymox Pharmaceutical"},{"orgOrder":0,"company":"Nymox Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nymox Announces NYMOZARFEX Marketing Application is Accepted For Review","therapeuticArea":"Urology","highestDevelopmentStatus":"Preclinical","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Nymox 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molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Dongkook Pharmaceutical"},{"orgOrder":0,"company":"Sumitomo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sumitomo Pharma Announces FDA Acceptance of Supplemental New Drug Application for Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia","therapeuticArea":"Urology","highestDevelopmentStatus":"Preclinical","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"May 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Sumitomo Pharma"}]

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            Gemtesa(vibegron) is a beta-3 adrenergic receptor agonist, small molecule drug candidate, which is indicated for the treatment of male overactive bladder (OAB) who are receiving pharmacological therapy for benign prostatic hyperplasia.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 13, 2024

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            DKF-313 is a combination of dutasteride (5α-reductase inhibitor) and tadalafil (PDE5 inhibitor). It is being evaluated in phase 3 clinical trials for the treatment of benign prostatic hyperplasia.

            Lead Product(s): Dutasteride,Tadalafil

            Therapeutic Area: Urology Product Name: DKF-313

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 26, 2023

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            Gemtesa (vibegron) is a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 11, 2023

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            Nymozarfex (fexapotide triflutate) causes selective apoptosis in the glandular portions of the prostate. It is currently being investigated for benign prostate enlargement (BPH).

            Lead Product(s): Fexapotide triflutate

            Therapeutic Area: Urology Product Name: Nymozarfex

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 15, 2023

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            Nymozarfex (fexapotide triflutate) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. Fexapotide has led to significant long-term improvements and has shown an excellent safety profile.

            Lead Product(s): Fexapotide triflutate

            Therapeutic Area: Urology Product Name: Nymozarfex

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 05, 2022

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            Dysport® is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which has previously shown clinically meaningful benefit in the symptomatic treatment of focal spasticity and cervical dystonia.

            Lead Product(s): Botulinum toxin type A

            Therapeutic Area: Urology Product Name: Dysport

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 09, 2022

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            NX-1207 (fexapotide triflutate), is a protein injectable for benign prostatic hyperplasia and for low grade localized prostate cancer, a new molecular entity which safely targets prostate glandular cells that have proliferated in BPH.

            Lead Product(s): Fexapotide triflutate

            Therapeutic Area: Urology Product Name: NX-1207

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 03, 2022

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            This investment follows the strategic license and collaboration agreement signed in 2021 to utilize Merz’s botulinum neurotoxin A (XEOMIN®) for the innovative ultrasound-assisted delivery catheter of Vensica.

            Lead Product(s): IncobotulinumtoxinA

            Therapeutic Area: Urology Product Name: Xeomin

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Merz Therapeutics

            Deal Size: $19.0 million Upfront Cash: Undisclosed

            Deal Type: Partnership February 07, 2022

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            Details:

            The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.

            Lead Product(s): Mirabegron

            Therapeutic Area: Urology Product Name: Myrbetriq

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 06, 2021

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            Details:

            Results from the 40-week EMPOWUR extension to the 12-week EMPOWUR trial shows that 75 mg of vibegron was well tolerated over the total exposure of 52 weeks with numerically greater improvements from baseline, compared to tolterodine across QoL and responder efficacy endpoints.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: KRP114V

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 19, 2020

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