Shares of Intercept Pharmaceuticals, Inc. ICPT fell after the company announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for priority review of its lead candidate, obeticholic acid (OCA), for the treatment of primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis.
The FDA was previously supposed to give a decision by Feb 29, 2016. However, the agency requested for additional clinical data analyses, which Intercept Pharma has now 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.
Additionally, the FDA has informed Intercept Pharma of a planned advisory committee meeting on Apr 7, 2016.
We remind investors that the Intercept Pharma is looking to get OCA approved for the treatment of PBC, in combination with ursodeoxycholic acid (UDCA) in adults who had inadequate response to UDCA, or as a monotherapy in adults who are unable to tolerate UDCA.
Our Take
A timely approval would have significantly boosted Intercept Pharma’s growth prospects as OCA is the lead candidate in its pipeline. Per estimates, one in 1,000 women over the age of 40 is affected by PBC. Moreover, PBC is the second leading overall cause of liver transplant in women in the U.S. after hepatitis C. Hence, the market potential for OCA is expected to be huge upon approval, given the unmet medical need for the indication.
Meanwhile, Intercept Pharma is evaluating OCA for additional indications like primary sclerosing cholangitis and non-alcoholic steatohepatitis.
We expect investor focus on further updates by the company on the FDA’s review of additional data.
Intercept currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Anika Therapeutics ANIK, Corcept Therapeutics CORT and Baxalta Inc. BXLT. All three sport a Zacks Rank#1 (Strong Buy).
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