[{"company":"Madrigal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Madrigal MAESTRO Phase 3 NASH Trials Continue without Protocol Modifications","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Madrigal Pharmaceuticals"},{"company":"Intercept Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"USFDA Postponds Intercept's NDA Application Meeting for Obeticholic Acid","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 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Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intercept Present New Data from the Interim Analysis of Regenerate Show that Oca Helped Patients with Liver Fibrosis Due to NASH","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Intercept Pharmaceuticals"},{"company":"Madrigal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Madrigal Pharmaceuticals Exceeds Target Enrollment in Phase 3 MAESTRO NAFLD-1 Trial","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular 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NASH","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Intercept Pharmaceuticals"},{"company":"Intercept Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New PBC and NASH Data to be Presented at AASLD\u2019s The Liver Meeting Digital Experience\u2122","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Intercept Pharmaceuticals"},{"company":"CymaBay Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CymaBay Therapeutics to Present Results from the ENHANCE Global Phase 3 Study Evaluating Seladelpar for Primary Biliary Cholangitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"CymaBay Therapeutics"},{"company":"Madrigal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Madrigal Pharma Completes Enrollment in Phase 3 MAESTRO NAFLD-1 Trial and Reports 2020 Third Quarter Financial Results and Highlights","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 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Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"CymaBay Therapeutics"},{"company":"Intercept Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Data from the Interim Analysis of Intercept Pharmaceuticals' REGENERATE Show OCA Improved Noninvasive Measures of Fibrosis in NASH Patients","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Intercept Pharmaceuticals"},{"company":"Albireo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Intercept Pharmaceuticals"},{"company":"Intercept Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intercept Pharmaceuticals Provides Update on Phase 3 REVERSE Trial in Compensated Cirrhosis Due to NASH","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Intercept Pharmaceuticals"},{"company":"Madrigal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Madrigal Provides Update on Timeline for 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Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective PPARδ agonist 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
August 01, 2022
Details:
Late-breaking data from double-blind portion of noninvasive Phase 3 MAESTRO NAFLD-1 study show MGL-3196 (resmetirom) to be safe and well-tolerated and to reduce liver fat, fibrosis measures on FibroScan and MRE, and liver enzymes, as well as multiple atherogenic lipids.
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
June 25, 2022
Details:
MBX-8025 (Seladelpar) is a first-in-class oral, selective PPARδ agonist 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
June 08, 2022
Details:
Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and reducing lipotoxicity.
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
June 08, 2022
Details:
OCALIVA (Obeticholic Acid), a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC).
Lead Product(s):
Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: Ocaliva
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
June 06, 2022
Details:
Data were presented demonstrating that MBX-8025 (seladelpar) treatment throughout 2 years resulted in a decrease in PBC GLOBE score and predicted improved transplant-free survival.
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
May 23, 2022
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective PPARδ agonist 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
May 11, 2022
Details:
An interim primary efficacy analysis of ALP change from baseline at Week 8 found that seladelpar, a selective PPARδ agonist, treatment provided 26%, 33%, and 41% reductions for the 2 mg, 5 mg and 10 mg doses, respectively (all p<0.005).
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
April 04, 2022
Details:
Madrigal’s lead candidate, resmetirom, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-β selective agonist that is currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO- NAFLD-1.
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
December 30, 2021
Details:
Company update that data from the Phase 3 REVERSE trial of Obeticholic acid is delayed and is expected in the first quarter of 2022. The primary endpoint is the percentage of patients with histological improvement in fibrosis by at least one stage with no worsening of NASH.
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
December 20, 2021
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