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Year Of NASH Upheaval Means Incremental Data At AASLD

Firms Are Retrenching, But There Are Signs Of Progress

Executive Summary

With still no approved therapy for non-alcoholic steatohepatitis, Intercept, Madrigal, Inventiva and others used the liver meeting to build the cases for their NASH candidates.

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CymaBay Focused On PBC With Seladelpar, Wants Partner For NASH

With an FDA clinical hold lifted, CymaBay plans to initiate a new Phase III in primary biliary cholangitis early in 2021. It also hopes to partner the drug in NASH with a company developing a metabolic drug for the disease.

Intercept Unlikely To Refile OCA For NASH Before Late 2021

Once determined to resubmit its NDA by the end of 2020, Intercept now says talks with the FDA have presented a new path to approval in non-alcoholic steatohepatitis that could mean refiling sometime in 2021.

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