Intercept Pharmaceuticals, Inc.
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Latest From Intercept Pharmaceuticals, Inc.
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.
RWE On The Runway: Trio Of Upcoming Approval Decisions Will Test US FDA’s Thinking On RWE For Efficacy
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.