Intercept (ICPT) Misses On Q4 Earnings & Sales
Zacks Investment Research | Feb 13, 2018 08:41PM ET
New York-based Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) focused on bringing novel therapeutics to treat chronic liver diseases to market.
Intercept received a major boost with the FDA approval (in May 2016) of its lead drug, Ocaliva, in combination with ursodeoxycholic (UDCA), for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
The FDA approved Ocaliva under its accelerated approval program based on a reduction in alkaline phosphatase (ALP), since an improvement in survival or disease-related symptoms has not been established yet. Continued approval in this indication may be contingent upon the verification and description of clinical benefit in confirmatory studies.
In Dec 2016, the European Commission granted conditional approval to Ocaliva for the same indication. Meanwhile, Ocaliva is being evaluated for other indications including non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
Intercept’s track record has been mixed so far, with the company surpassing expectations in three of the last four quarters. The company has posted an average positive surprise of 0.82% over this period.
Intercept Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
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