Hepatology (Liver, Pancreatic, Gall Bladder) | Phase III Developments

Intercept Pharma

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United States

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USFDA Postponds Intercept's NDA Application Meeting for Obeticholic Acid

Lead Product(s): Obeticholic Acid

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

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 May 22, 2020

Details:

U.S.FDA has notified Intercept that its advisory committee meeting (AdCom) relating to the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed.

Genfit

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FRANCE France

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Genfit Delivers Latest NASH Drug Failure

Lead Product(s): Elafibranor

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

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 May 11, 2020

Details:

Elafibranor did not demonstrate a statistically significant effect on the primary endpoint of NASH resolution without worsening of fibrosis.

Madrigal Pharmaceuticals

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Madrigal MAESTRO Phase 3 NASH Trials Continue without Protocol Modifications

Lead Product(s): Resmetirom

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

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 April 14, 2020

Details:

Once daily oral 80 mg and 100 mg Phase 3 doses of resmetirom deliver at least 50% to more than 60% reductions in liver fat, respectively.

Genfit

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FRANCE France

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Genfit says Covid-19 may not significantly delay NASH trial readout

Lead Product(s): Elafibranor

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

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 April 01, 2020

Details:

Company does not expect any significant delay in the interim data readout of its Phase III RESOLVE-IT clinical trial of elafibranor in non-alcoholic steatohepatitis with fibrosis.