With a 22 June US FDA action date for obeticholic acid in non-alcoholic steatohepatitis, Intercept is thinking ahead to launch plans. Madrigal said it plans a Q2 filing for its NASH drug and hopes to find an ex-US commercial partner.

In a draft assessment, the non-profit said Madrigal’s non-alcoholic steatohepatitis candidate might yield cost savings over a lifetime of care. Both drugs seem to offer incremental benefits for survival and quality of life.

Two clinical trial announcements in the same NASH indication separated by almost nine years had very similar stock price reactions despite the known unknowns of NASH remaining unknown.

Nearly two-and-a-half years after an FDA complete response letter stalled obeticholic acid’s path to the first approval in non-alcoholic steatohepatitis, Intercept refiled its NDA on 23 December.