FDA declines to approve Intercept’s Ocaliva

Today the FDA announced that it had declined to approve Ocaliva for treatment of NASH. Intercept Pharmaceuticals was set to be the first FDA approved NASH treatment, despite relatively mediocre Phase 3 Results announced in late 2019. This is a major disappointment for the tens of millions of NASH patients that were hoping for an imminent treatment to be available.

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Intercept Pharma announces successful Phase 3 NASH trials

Will move for approval in US and Europe later this year

Eagerly awaited Phase 3 trial results were released early Tuesday morning from Intercept Pharmaceuticals,¬†showing positive results for the study’s primary goal of showing a statistically significant reduction in liver fibrosis compared to placebo. As a result, Intercept will seek approval in the US and Europe to permit the drug, known as Ocaliva, to be used as the first ever treatment for NASH-related fibrosis. The stock price rose as high as 23% on the news.

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