Intercept Pharmaceuticals, Inc.
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Latest From Intercept Pharmaceuticals, Inc.
Intercept Plans To Refile OCA For NASH At US FDA With Consensus Reads Of Patient Biopsies
Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.
NASH Updates: Intercept Moves Toward Re-Filing, Madrigal De-Risks Phase III
AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.
Metacrine’s Shift Means Further Attrition In FXR Agonist Class For NASH
Metacrine halts development of its FXR agonist compounds in NASH and turn its focus to inflammatory bowel disease. Firm plans Phase II ulcerative colitis study in 2022 with MET642.
Metacrine Choosing Between Two NASH FXR Agonists It Calls Best-In-Class
Biotech is determining which of its mid-stage FXR candidates – MET409 and MET642 – will offer the best overall profile to take into Phase IIb. It is also studying ‘409 in combination with Jardiance and will test the FXR class in inflammatory bowel disease.
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