Cytodyn Inc (CYDY)

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Intercept might just give up on NASH
Later today, the FDA will hand down a final decision on Intercept Pharmaceuticals’ treatment for the liver disease NASH, a drug whose promise once quadrupled in a single day. And that decision is almost certainly going to be negative.

Last month, a panel of agency advisers voted 15-1 in favor of rejecting Intercept’s application for accelerated approval, meaning the company would have to spend the next three years collecting enough data to apply for a traditional approval. And that might not be worth the wait, according to CEO Jerome Durso, who told analysts the company is “prepared to pivot to profitability” if things don’t work out.

Back in 2014, Intercept became the hottest company in the industry on news that its NASH drug had worked so well that a mid-stage clinical trial was stopped early, setting off a pharmaceutical gold rush to find what would be the first treatment for the increasingly prevalent disease. Nine years and a 98% stock price decline later, Intercept, the company that put NASH on the biotech map, might stop investing in the disease altogether.
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