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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"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Receives FDA Fast Track Designation for Setanaxib in PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Grants Fast Track Status to Calliditas\u2019 Setanaxib for PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Randomized in Pivotal TRANSFORM Study with Setanaxib","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Randomized in Phase 2 Trial in Head and Neck Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Announces Supportive Interim Data From Phase 2 Head and Neck Cancer Trial with Lead NOX Inhibitor Candidate, Setanaxib","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Therapeutics Granted Orphan Drug Designation by the FDA for the Treatment of Alport Syndrome with Setanaxib","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"IND Enabling"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Committee for Orphan Medicinal Products Provides Positive Opinion On Calliditas' Application for Setanaxib in Alport Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"IND Enabling"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Initiates Clinical Study to Evaluate Setanaxib in Alport Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Announces Positive Topline Results of Phase 2 Head and Neck Cancer Trial with Lead NOX Inhibitor Candidate, Setanaxib","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]

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              Calliditas Therapeutics AB

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              Calliditas Announces Positive Topline Results of Phase 2 Head and Neck Cancer Trial with Lead NOX Inhibitor Candidate, Setanaxib

              Details:

              GKT 831 (setanaxib) is a first‐in‐class selective NOX 1/4 inhibitor. It is being evaluated for the treatment of patients with squamous cell carcinoma of the head and neck.

              Lead Product(s): Setanaxib,Pembrolizumab

              Therapeutic Area: Oncology Product Name: GKT 831

              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 May 06, 2024

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              Calliditas Therapeutics AB

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              Calliditas Initiates Clinical Study to Evaluate Setanaxib in Alport Syndrome

              Details:

              GKT137831 (setanaxib) is a small molecule oral inhibitor which works by targeting NOX 1/NOX 4, it is currently being investigated for the treatment of Alport syndrome.

              Lead Product(s): Setanaxib

              Therapeutic Area: Genetic Disease 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 November 30, 2023

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              Calliditas Therapeutics AB

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              European Medicines Agency Committee for Orphan Medicinal Products Provides Positive Opinion On Calliditas' Application for Setanaxib in Alport Syndrome

              Details:

              GKT137831 (setanaxib), an oral tablet, is a NOX 1 and 4 inhibitor, which is being investigated for the treatment of Alport syndrome and orphan drug designation by the FDA.

              Lead Product(s): Setanaxib

              Therapeutic Area: Genetic Disease Product Name: GKT137831

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 05, 2023

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              Calliditas Therapeutics AB

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              Calliditas Therapeutics Granted Orphan Drug Designation by the FDA for the Treatment of Alport Syndrome with Setanaxib

              Details:

              GKT137831 (setanaxib), an oral tablet, is a NOX 1 and 4 inhibitor, which is being investigated for the treatment of Alport syndrome and orphan drug designation by the FDA.

              Lead Product(s): Setanaxib

              Therapeutic Area: Genetic Disease Product Name: GKT137831

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 27, 2023

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              Calliditas Therapeutics AB

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              Calliditas Announces Supportive Interim Data From Phase 2 Head and Neck Cancer Trial with Lead NOX Inhibitor Candidate, Setanaxib

              Details:

              GKT137831 (setanaxib), an oral tablet, is a NOX 1 and 4 inhibitor, which is being investigated in Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN).

              Lead Product(s): Setanaxib,Pembrolizumab

              Therapeutic Area: Oncology 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 July 13, 2023

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              Calliditas Therapeutics AB

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              First Patient Randomized in Phase 2 Trial in Head and Neck Cancer

              Details:

              GKT831(setanaxib), a NOX1 and NOX4 inhibitor, has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, an orphan liver disease).

              Lead Product(s): Setanaxib,Pembrolizumab

              Therapeutic Area: Oncology Product Name: GKT831

              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 May 17, 2022

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              Calliditas Therapeutics AB

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              First Patient Randomized in Pivotal TRANSFORM Study with Setanaxib

              Details:

              The TRANSFORM Phase 2b/3 trial for GKT831 (setanaxib), a NOX1 and NOX4 inhibitor, will investigate the effect of setanaxib versus placebo on alkaline phosphatase reduction in patients with PBC also has shown evidence of anti-fibrotic activity in a Phase II clinical trial.

              Lead Product(s): Setanaxib

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

              Highest Development Status: Phase II/ 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, 2022

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              Calliditas Therapeutics AB

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              Calliditas Receives FDA Fast Track Designation for Setanaxib in PBC

              Details:

              Following positive results from a Phase 1 study conducted in 2020 which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC.

              Lead Product(s): Setanaxib

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

              Highest Development Status: Phase II/ Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 09, 2021

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              Calliditas Therapeutics AB

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              US FDA Grants Fast Track Status to Calliditas’ Setanaxib for PBC

              Details:

              In a Phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue.

              Lead Product(s): Setanaxib

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

              Highest Development Status: Phase II/ Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 09, 2021

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              Genkyotex

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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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