Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.

AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.

At EASL 2021, Akero presented efruxifermin data showing benefit in cirrhotic NASH patients and strong liver fat reduction, but may be challenged in the FGF21 analog class by 89Bio.

NGM will not proceed with a Phase III study in F2/F3 NASH following failure to show fibrosis benefit in Phase IIb. Analysts say this setback could portend disappointing readouts for other NASH players.