With Akero’s FGF21 analog showing ability to reduce fibrosis and resolve non-alcoholic steatohepatitis, some analysts think classmate BIO89-100 could yield a better overall profile. NASH data are starting to pour in.

Looking ahead to lengthy, expensive Phase III NASH studies, Akero looks to tap public markets for $200m. Analysts call EFX’s Phase IIb data potentially best-in-class.

Real-world evidence provides external controls for bluebird bio’s eli-cel and Ipsen’s palovarotene, while Reata used RWE to address FDA concerns about the pivotal single-arm study of omaveloxolone. In the post-market, Intercept is gearing up to seek full approval of Ocaliva relying in part on claims database.

Interecept is reviving hopes that it will be able to capture a potential blockbuster indication for its liver disease drug Ocaliva. The development strategy might never happen again if the US drug pricing bill becomes law.