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    [{"orgOrder":0,"company":"Genkyotex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genkyotex Receives Approval From the French Medicines Agency (ANSM) to Initiate a Phase 1 Clinical Study With High-dose Setanaxib","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Genkyotex","sponsor":"Genkyotex","pharmaFlowCategory":"D","amount":"$37.7 million","upfrontCash":"Undisclosed","newsHeadline":"Calliditas Announces Agreement to Acquire Controlling Interest in Genkyotex SA","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Genkyotex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genkyotex SA, a subsidiary of Calliditas Therapeutics Announced Positive Phase 1 Results in High-Dose Setanaxib Trial","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"}]

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              Genkyotex SA, a subsidiary of Calliditas Therapeutics Announced Positive Phase 1 Results in High-Dose Setanaxib Trial

              Details:

              The Phase 1 study Showed that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified. The study assessed the safety and pharmacokinetics of oral setanaxib at select doses in 46 healthy adult male and female subjects.

              Lead Product(s): Setanaxib

              Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT137831

              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 January 18, 2021

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              Calliditas Announces Agreement to Acquire Controlling Interest in Genkyotex SA

              Details:

              Transaction adds orphan pipeline asset and platform in inflammation and fibrosis. Genkyotex’s lead clinical candidate, setanaxib, is in development for Primary Biliary Cholangitis.

              Lead Product(s): Setanaxib

              Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Genkyotex

              Deal Size: $37.7 million Upfront Cash: Undisclosed

              Deal Type: Acquisition August 13, 2020

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              Genkyotex

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              Genkyotex Receives Approval From the French Medicines Agency (ANSM) to Initiate a Phase 1 Clinical Study With High-dose Setanaxib

              Details:

              This Phase 1 study will evaluate setanaxib at doses up to 1600 mg/day in up to 54 subjects. Genkyotex is currently discussing the registration strategy for setanaxib in PBC with FDA and EMA.

              Lead Product(s): Setanaxib

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

              Highest Development Status: Phase I Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 13, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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