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Find Drugs for Genetic Disease in Phase II Clinical Development in DENMARK

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            Lead Product(s): Tesofensine,Metoprolol

            Therapeutic Area: Genetic Disease Product Name: Tesomet

            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 April 21, 2021

            Details:

            The company requested FDA feedback, and the FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing.

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            Lead Product(s): Tesofensine,Metoprolol

            Therapeutic Area: Genetic Disease Product Name: Tesomet

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Saniona

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership April 19, 2021

            Details:

            Saniona is currently planning to initiate a Phase 2b study of Tesomet in PWS in the first half of 2021. Saniona is also evaluating Tesomet for the treatment of hypothalamic obesity (HO) and plans to begin a Phase 2b trial in this indication in the first half of this year.

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            Lead Product(s): Tesofensine,Metoprolol

            Therapeutic Area: Genetic Disease Product Name: Tesomet

            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 09, 2020

            Details:

            FDA recommended that Saniona conduct a supportive Phase 2b study prior to initiating a Phase 3 study to confirm the safety and efficacy of the doses intended for commercialization.

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            Lead Product(s): TransCon CNP

            Therapeutic Area: Genetic Disease Product Name: TransCon CNP

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 12, 2020

            Details:

            TransCon CNP is a investigational long-acting prodrug of CNP, designed to provide continuous exposure of CNP at safe, therapeutic levels via a single, weekly subcutaneous dose.

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            Lead Product(s): Arimoclomol

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            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 June 29, 2020

            Details:

            Arimoclomol demonstrated a marked and clinically meaningful dose-dependent reduction in liver and spleen size. Data supports Orphazyme's intention to proceed with pivotal stage clinical development in Gaucher disease .