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Madrigal Pharmaceuticals Inc.

www.madrigalpharma.com

Latest From Madrigal Pharmaceuticals Inc.

Intercept’s NASH NDA Positions OCA For May 2020 Approval, Then Launch

Intercept hopes to be first to market in NASH with an indication to treat fibrosis. It also is enrolling a study to show a benefit in NASH patients with cirrhosis.

Drug Approval Standards Clinical Trials

Intercept Could Face Tougher Road To NASH Approval In EU Than US

Recently filed NDA for obeticholic acid relies on US FDA's specified endpoints for treatment of fibrosis, but European standards are less clear cut, the company acknowledges.

Drug Approval Standards Clinical Trials

Genfit Assesses Optimal Elafibranor NASH Combo Therapy Opportunity

As it nears the Phase III data readout for elafibranor in NASH, Genfit plans combo therapy studies to determine if a GLP-1 analog or SGLT2 inhibitor would offer the best therapeutic synergy, market potential and partnership opportunity.

Business Strategies Drug Approval Standards

CymaBay Alters NASH Hypothesis After Phase IIb Failure In Hepatic Fat Reduction

Firm points to liver biomarker findings, saying they may yield clear liver benefit at 52 weeks. Both CymaBay's and Genfit's stock prices fell as investors wondered about broader read-through for the PPAR agonist class.

Liver & Hepatic Clinical Trials
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