Year Of NASH Upheaval Means Incremental Data At AASLD
Firms Are Retrenching, But There Are Signs Of Progress
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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Join us for a brief audio tour around the past week's key developments in the global biopharma industry, in this podcast version of Scrip's Five Must-Know Things.
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.
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.