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Intercept (ICPT) Up Ahead of Advisory Committee Meeting

Shares of Intercept Pharmaceuticals, Inc. ICPT surged 13.3% just before the FDA Gastrointestinal Drug Advisory Committee’s (GIDAC) meeting scheduled for Apr 7, 2016.

The committee will discuss Intercept Pharma’s New Drug Application (NDA) for its lead candidate, obeticholic acid (OCA). The company is seeking approval for OCA, in combination with ursodeoxycholic acid (UDCA), for the treatment of primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

We note that UDCA is the only drug currently approved in the U.S. for the treatment of PBC. As per the briefing documents released, response rates at the end of three months in a pooled dataset from two phase II studies and a phase III study showed that OCA was effective as monotherapy in adult subjects who were unable to tolerate UDCA. Moreover, patients with early-stage PBC showed alkaline phosphatase reductions, when treated with OCA 10 mg and 50 mg monotherapy, higher than the placebo arm.

Data showed an overall favorable benefit-risk profile of OCA therapy, when used in combination with UDCA for the treatment of PBC in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. However, safety issues continue to be matter of concern in severely affected patients and less frequent dose might be recommended for such patients. A potential approval should boost the growth prospects of the company.

In Dec 2015, the FDA extended the Prescription Drug User Fee Act (PDUFA) date for priority review of OCA by three months. The agency was previously supposed to give a decision by Feb 29, 2016. However, it requested for additional clinical data analyses, which Intercept had submitted. Consequently, the FDA requires additional time for a full review of the submission and has extended the PDUFA date by three months to May 29, 2016.

Intercept Pharma currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Endocyte Inc. ECYT, ArQule Inc. ARQL and Sucampo Pharmaceuticals SCMP. All the three stocks sport a Zacks Rank #1 (Strong Buy).

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