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Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint

Executive Summary

Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.

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Intercept Commits To Resubmitting NASH NDA, But Analysts See Conflicting Signs

CEO Durso says Intercept is aiming to refile its NDA by end of 2021, but several departures in recent months indicate pessimism on NASH prospects to some analysts.

Intercept Unlikely To Refile OCA For NASH Before Late 2021

Once determined to resubmit its NDA by the end of 2020, Intercept now says talks with the FDA have presented a new path to approval in non-alcoholic steatohepatitis that could mean refiling sometime in 2021.

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