CymaBay Shelves NASH Drug Seladelpar On Liver Safety Concerns
Atypical histological findings from a Phase IIb NASH study lead CymaBay to terminate mid-stage studies in NASH and PSC and place a Phase III PBC trial on hold.
You may also be interested in...
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.
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.
EASL Updates: Intercept Says Biomarker Data Bolster OCA’s Case For Fibrosis Benefit
Intercept and Axcella provide updated data on their NASH programs at the International Liver Conference, while CymaBay offers the full dataset for seladelpar in PBC.