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    [{"orgOrder":0,"company":"Abionyx Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ABIONYX Initiates a Phase 2a Clinical Trial with CER-001 in Septic Patients at High Risk of Developing Acute Kidney Injury","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase II"},{"orgOrder":0,"company":"Abionyx Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ABIONYX Pharma Receives FDA Orphan Drug Designation (ODD) for CER-001 for the Treatment of LCAT Deficiency Presenting as Kidney Dysfunction and\/or Ophthalmologic Disease","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Abionyx Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ABIONYX Pharma Reports Positive Interim Results From Phase 2a Clinical Trial Evaluating CER-001 in the Treatment of Septic Patients at High Risk of Developing Acute Kidney Injury","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase II"},{"orgOrder":0,"company":"Abionyx Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Abionyx Pharma Reports Positive Results from Phase 2a Pilot Clinical Trial Evaluating CER-001 in the Treatment of Septic Patients at High Risk of Developing Acute Kidney Injury","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"}]

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              Abionyx Pharma

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              Abionyx Pharma Reports Positive Results from Phase 2a Pilot Clinical Trial Evaluating CER-001 in the Treatment of Septic Patients at High Risk of Developing Acute Kidney In...

              Details:

              CER-001 is a novel engineered HDL-mimetic comprised of recombinant human apoA-I and phospholipids, designed to mimic the beneficial properties of nascent pre-β HDL. It is being investigated for the treatment of septic patients at high risk of developing acute kidney injury.

              Lead Product(s): CER-001

              Therapeutic Area: Infections and Infectious Diseases Product Name: CER-001

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 16, 2023

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              Abionyx Pharma

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              ABIONYX Pharma Reports Positive Interim Results From Phase 2a Clinical Trial Evaluating CER-001 in the Treatment of Septic Patients at High Risk of Developing Acute Kidney ...

              Details:

              The results to date with CER-001 are consistent with the known pleiotropic effects of HDL, scavenging endotoxin, reversing the cytokine cascade and improving endothelial function.

              Lead Product(s): Human recombinant apoA-I,Sphingomyelins,Dipalmitoylphosphatidylglycerol

              Therapeutic Area: Nephrology Product Name: CER-001

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 07, 2022

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              ABIONYX Pharma Receives FDA Orphan Drug Designation (ODD) for CER-001 for the Treatment of LCAT Deficiency Presenting as Kidney Dysfunction and/or Ophthalmologic Disease

              Details:

              CER-001 is the first-in-class bio-HDL mimetic that directly targets a key underlying metabolic defect of LCAT deficiency. The bio-HDL is one of the most advanced biomedicines and is a potential novel treatment for kidney diseases.

              Lead Product(s): Human Recombinant ApoA-I,Sphingomyelins,Dipalmitoylphosphatidylglycerol

              Therapeutic Area: Rare Diseases and Disorders Product Name: CER-001

              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 March 29, 2022

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              Abionyx Pharma

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              ABIONYX Initiates a Phase 2a Clinical Trial with CER-001 in Septic Patients at High Risk of Developing Acute Kidney Injury

              Details:

              ABIONYX has received authorization to launch a clinical RACERS trial (a RAndomized study comparing short-term CER-001 infusions at different doses to prevent Sepsis-induced acute kidney injury) with CER-001 in septic patients at high risk of developing acute kidney injury.

              Lead Product(s): Human recombinant apoA-I,Sphingomyelins,Dipalmitoylphosphatidylglycerol

              Therapeutic Area: Nephrology Product Name: CER-001

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 23, 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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