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

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              Orphazyme

              • Development Update

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              DENMARK Denmark

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              IFT Annual Expo

              Participation Not Confirmed

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              Orphazyme Phase 2 Study of Arimoclomol In Gaucher Disease Demonstrates Marked Improvements in Key Clinical Markers

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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 24, 2020

              Details:

              The data show a dose-dependent effect of arimoclomol on certain disease-relevant clinical secondary endpoints, such as liver and spleen size.

              Saniona

              • Development Update

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              DENMARK Denmark

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              IFT Annual Expo

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              Saniona Receives Positive Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS)

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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 June 09, 2020

              Details:

              The positive feedback regarding the proposed regulatory path for Tesomet confirmed that Tesomet may be advanced via the 505(b)2 pathway, and the agency indicated agreement with Saniona on the design, the proposed doses, and duration of the potential Phase 2b clinical trial in PWS.

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