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Find Drugs for Hepatology (Liver, Pancreatic, Gall Bladder) in Phase III Clinical Development

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            MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor (PPAR) delta agonist, or delpar, shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.

            Lead Product(s): Seladelpar

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 23, 2023

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            Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and NMPA has accepted the New Drug Application for the treatment of Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis.

            Lead Product(s): Maralixibat

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 17, 2023

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            Madrigal will use the proceeds for its clinical and commercial activities in preparation for a potential launch of MGL-3196 (resmetirom), a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.

            Lead Product(s): Resmetirom

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Goldman Sachs & Co. LLC

            Deal Size: $500.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 28, 2023

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            MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor (PPAR) delta agonist, or delpar, shown to regulate critical metabolic and primary biliary cholangitis pathways in indications with high unmet medical need.

            Lead Product(s): Seladelpar

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2023

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            Under the agreement, Hepalys will develop and commercialize Inventiva’s proprietary drug candidate IVA337 (lanifibranor), an orally-available small molecule, PPAR agonist, for the treatment of non-alcoholic steatohepatitis (NASH) in Japan and South Korea.

            Lead Product(s): Lanifibranor

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Hepalys Pharma

            Deal Size: $241.0 million Upfront Cash: $10.0 million

            Deal Type: Licensing Agreement September 20, 2023

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            CymaBay anticipates using the net proceeds to fund ongoing development of MBX-8025, including clinical trials targeting market expansion. Seladelpar is a first-in-class investigational, PPAR-δ agonist, for the treatment of people with primary biliary cholangitis.

            Lead Product(s): Seladelpar

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Piper Sandler

            Deal Size: $258.7 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 14, 2023

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            MGL-3196 (resmetirom) is a once daily, oral, thyroid hormone receptor (THR)-beta selective agonist designed to target key underlying causes of NASH in the liver.

            Lead Product(s): Resmetirom

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2023

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            CymaBay anticipates using the net proceeds to fund ongoing development of MBX-8025, including clinical trials targeting market expansion. Seladelpar is a first-in-class investigational, PPAR-δ agonist, for the treatment of people with primary biliary cholangitis.

            Lead Product(s): Seladelpar

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Piper Sandler

            Deal Size: $225.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 11, 2023

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