Shares of Intercept Pharmaceuticals (ICPT) soared almost 20% this morning after the company announced that it had received Breakthrough Therapy Designation (BTD) for its investigational OCA drug for non-alcoholic steatohepatitis (NASH). The drug OCA -- Obeticholic Acid -- is an FXR (farnesoid X receptor) agonist used to treat NASH in liver disease patients. NASH occurs when patients have a buildup of fat in the liver that causes severe damage and inflammation in the patient's body. 

To receive a breakthrough therapy designation, the biotechnology company must create a treatment for patients that is superior to other current market products or, if no market products are available for the intended disease, then the drug must be superior to its placebo counterpart. OCA from Intercept showed a statistically significant improvement in NASH patients compared to placebo. The trial, known as "FLINT", was stopped early because the OCA drug reached its primary endpoint well before the study had finished. 

NASH is expected to become the the main reason for liver transplants and there are currently no FDA approved drugs to treat NASH. Therefore the FDA is intent on approving a drug that will help patients who live with this disease. The Breakthrough Therapy designation allows many benefits such as priority interaction with the FDA, and a rolling NDA submission, which will allow Intercept to submit completed portions of its application on an ongoing basis. This will allow a quicker approval if and when the FDA does decide to approve the drug.