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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NYMOX Announces New Marketing Submission for NYMOZARFEX for BPH","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","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":"Phase III","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Nymox Pharmaceutical"}]

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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: Phase III 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: Phase III 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: Phase III 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: Phase III 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: Phase III 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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            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: Phase III 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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            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: Phase III 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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            Details:

            The merger may enable Urovant's team to fully concentrate on the important task of preparing for its potential commercial launch of vibegron, the first new branded prescription drug for the treatment of OAB in nearly a decade.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: RVT-901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sumitovant Biopharma

            Deal Size: $584.0 million Upfront Cash: Undisclosed

            Deal Type: Merger November 12, 2020

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            Details:

            Under the terms of the agreement, Sunovion will deploy its multi-specialty sales force to bring vibegron to primary care physicians (PCP). In support of this effort, Sunovion will provide sales and marketing activities targeting the PCP segment through March 31, 2026.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: RVT-901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Urovant Sciences

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement October 07, 2020

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            The exclusive three-year distribution agreement with aims to support the commercialization of vibegron, an investigational agent for the treatment of overactive bladder.

            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sumitovant Biopharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration June 19, 2020

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