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[{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces Publication of Imeglimin Clinical Study Results in Clinical Pharmacokinetics","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces Program Update and Preclinical Results on PXL770 for NASH Combinations and Other Metabolic Diseases","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"JMP Securities LLC","pharmaFlowCategory":"D","amount":"$19.4 million","upfrontCash":"Undisclosed","newsHeadline":"Poxel Successfully Raises \u20ac17.7 Million in a Capital Increase","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces Positive Pharmacokinetic (PK) \/ (PD) Study Results for PXL770","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Sumitomo Pharma","pharmaFlowCategory":"D","amount":"$21.3 million","upfrontCash":"Undisclosed","newsHeadline":"Poxel Announces Submission of Imeglimin Japanese New Drug Application for the Treatment of Type 2 Diabetes by Sumitomo Dainippon Pharma","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Initiates Phase 2 NASH Trial for PXL065 (DESTINY 1) in Biopsy-Proven Patients","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Presents Imeglimin Phase 3 TIMES Results and PXL770 Preclinical Cardio-Renal Results at the 56th EASD Annual Meeting","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces Positive Results From Phase 2a NASH Trial With PXL770, an Oral First-in-Class Direct AMPK Activator","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces Upcoming Poster Presentations at AASLD The Liver Meeting\u00ae 2020","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Presents Phase 1b Clinical Results for PXL065 and New Preclinical Data for PXL770 at AASLD The Liver Meeting\u00ae 2020","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Metavant Sciences","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Poxel Regains Imeglimin Rights From Metavant","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Presents Results of Two Clinical Studies on its Direct AMP Kinase Activator, the PXL770, at the ILC 2021","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces PXL065 and PXL770 Granted Orphan Drug Designation from the U.S. FDA for X-Linked Adrenoleukodystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces New Solid Form Patent for PXL065 that Provides Additional Protection through 2041","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces the Publication of Two Preclinical Articles on X-Linked Adrenoleukodystrophy for PXL065 and PXL770","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces Positive Histology Results from Phase 2 NASH Trial (DESTINY-1) for PXL065, a Novel, Proprietary Deuterium-Stabilized R-Stereoisomer of Pioglitazone","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Announces PXL770 Granted Orphan Drug Designation from the U.S. FDA for Autosomal-Dominant Polycystic Kidney Disease (ADPKD)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel to Present DESTINY-1 Phase 2 Results for PXL065 in NASH at AASLD The Liver Meeting\u00ae 2022","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poxel Receives Orphan Drug Designation from the European Commission for PXL770 and PXL065 for Treatment of Adrenoleukodystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Poxel","sponsor":"Sumitomo Pharma","pharmaFlowCategory":"D","amount":"$299.0 million","upfrontCash":"$42.0 million","newsHeadline":"Poxel and Sumitomo Dainippon Pharma Announce the Approval of TWYMEEG\u00ae (Imeglimin hydrochloride) for the Treatment of Type 2 Diabetes in Japan","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"}]

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            Details:

            PXL770 is a novel, firstin-class direct adenosine monophosphate-activated protein kinase (AMPK) activator. PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which exerts effects via multiple non-genomic pathways engaged by thiazolidinedione.

            Lead Product(s): PXL770

            Therapeutic Area: Genetic Disease Product Name: PXL770

            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 25, 2023

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            PXL065 is a novel, proprietary deuterium-stabilized R-pioglitazone. PXL065 was observed to be safe and well tolerated with no dose-dependent increase in body weight and no increased lower extremity edema vs. placebo.

            Lead Product(s): Deuterium Stabilized (R)‐Pioglitazone

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: PXL065

            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 12, 2022

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            PXL770 is a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator. AMPK is a central regulator of multiple metabolic pathways leading to the control of lipid metabolism, glucose homeostasis and inflammation.

            Lead Product(s): PXL770

            Therapeutic Area: Genetic Disease Product Name: PXL770

            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 October 03, 2022

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            PXL065 (deuterated pioglitazone) Phase 2 trial for the treatment of NASH met its primary efficacy endpoint for liver fat content reduction at 36-weeks for all doses.

            Lead Product(s): Deuterium Stabilized (R)‐Pioglitazone

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: PXL065

            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 September 22, 2022

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            PXL065 is a novel, proprietary deuteriumstabilized R-stereoisomer of pioglitazone which exerts effects via multiple non-genomic pathways engaged by thiazolidinedione molecules.

            Lead Product(s): Deuterated Pioglitazone

            Therapeutic Area: Genetic Disease Product Name: PXL065

            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 05, 2022

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            PXL065 is the deuterated-stabilized R stereoisomer (single R-isomer) of pioglitazone, its parent molecule. It is currently being evaluated in a Phase 2 study (DESTINY-1) for NASH, with results expected in Q3 2022.

            Lead Product(s): Deuterated Pioglitazone

            Therapeutic Area: Genetic Disease Product Name: PXL065

            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, 2022

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            PXL065 (deuterium-stabilized R-pioglitazone) was observed to ameliorate key features of ALD in preclinical models, including both patient-derived cells and a classical rodent disease model.

            Lead Product(s): Deuterated Pioglitazone

            Therapeutic Area: Genetic Disease Product Name: PXL065

            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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            Details:

            The results showed that treatment with PXL770 at 500 mg QD resulted in significant reductions in mean liver fat content and alanine transaminase (ALT) levels (vs. baseline).

            Lead Product(s): PXL770

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: PXL770

            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 25, 2021

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            The companies entered into a strategic partnership for the development and commercialization of Twymeeg (imeglimin hydrochloride) in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries.

            Lead Product(s): Imeglimin Hydrochloride

            Therapeutic Area: Endocrinology Product Name: Twymeeg

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sumitomo Pharma

            Deal Size: $299.0 million Upfront Cash: $42.0 million

            Deal Type: Partnership June 23, 2021

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            Details:

            Metavant will return all rights to Imeglimin to Poxel, as well as all data, materials, and information, including FDA regulatory filings, related to the program. Metavant is not entitled to any payment from Poxel as part of the return of the program.

            Lead Product(s): Imeglimin Hydrochloride

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Metavant Sciences

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Terminated January 14, 2021

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