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NASH Backlash: Intercept Delay Raises Questions

 
• By Andy Smith, Joseph Haas, and Lucie Ellis-Taitt

A complete response letter from the FDA in June knocked Intercept’s stock price down to 2014 levels, but perhaps the regulator is sending wider messages about NASH.

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On the Sunday night before the 2014 JP Morgan Healthcare conference, Intercept Pharmaceuticals, Inc. was the talk of the town in the bars around San Francisco. This was because of its recently announced positive results for obeticholic acid (OCA) in non-alcoholic steatohepatitis (NASH). Six years later, the FDA has issued a complete response letter (CRL) for OCA in NASH amid consternation on OCA’s safety, efficacy, surrogate endpoints and the real number of NASH patients.

That 2014 JP Morgan conference was Intercept’s coming-out party. The announcement of the positive results from an interim analysis of...

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