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Stockwatch: Intercepting The Falling Knives Of NASH

Misperceptions Of Safety And Efficacy Plus The Invalidation Of A Surrogate Marker Hit Intercept

 
• By Andy Smith

A complete response letter from the FDA knocked Intercept’s stock price for six, but perhaps the FDA is sending wider messages about NASH.

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ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

On the Sunday night before the 2014 J.P. 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 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 J.P. Morgan conference was Intercept’s coming-out party. The announcement of the positive results from an interim analysis of...

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