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Intercept Thinks Fibrosis Effect Could Carry Its NASH Candidate

Executive Summary

With Phase II data in its pocket showing a promising reduction in fibrosis, Intercept is eager to begin Phase III study of obeticholic acid in NASH. But regulators are still uncertain about what endpoints should be used and concerns about LDL levels in Phase II have driven the firm’s stock price down.

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ICER Determines OCA’s Benefit In NASH Might Support Limited Approval

The cost-effectiveness watchdog group sees the fibrosis benefit with Intercept’s obeticholic acid as supporting use in sicker NASH patients, but its overall risk-benefit ratio doesn’t merit broader use.

Intercept Retakes The Lead In NASH

A week after Gilead missed its primary endpoint in the first Phase III NASH trial, Intercept shows a statistically significant fibrosis benefit in Phase III with OCA. It plans to file for approval later this year.

Gilead’s FXR Agonist Posts Questionable Results In NASH, But Offers Hope In PSC

Although GS-9674’s efficacy data don’t appear as promising as that for Intercept’s competing FXR agonist OCA, Gilead seems to be building an argument that its drug has a better combination of efficacy and safety.

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