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Intercept Pharmaceuticals, Inc.

http://www.interceptpharma.com

Latest From Intercept Pharmaceuticals, Inc.

When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

Drug Review Review Pathway

Intercept Wants More Time to Address EMA’s Questions Over Its NASH Treatment

The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.

Drug Review Liver & Hepatic

CymaBay Builds Seladelpar Case In PBC, But Door Not Closed On NASH

The company pointed to cirrhosis benefit and less pruritis in a pooled analysis presented at EASL, which will help it will take on Intercept in primary biliary cholangitis on tolerability, cirrhosis benefit.

Clinical Trials Business Strategies

Madrigal Solidifies Presumed NASH Lead With 52-Week Data

Full-year findings for resmetirom reported at EASL confirm 16-week data in non-alcoholic steatohepatitis presented in 2020. Analysts say these data continue to de-risk the drug, but more important readouts await.

Clinical Trials Business Strategies
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