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Intercept Pharmaceuticals, Inc.

http://www.interceptpharma.com

Latest From Intercept Pharmaceuticals, Inc.

Akero’s Phase II Success Could Augur Brighter Days For NASH R&D

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.

Business Strategies Clinical Trials

Akero Looks To Double Its Cash Following Strong Phase IIb NASH Data

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.

Business Strategies Financing

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.

Real-World Evidence Drug Review

Intercept’s NASH Hopes: A Case Study For Implications Of US Pricing Bill

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.

Pricing Debate Rare Diseases
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