Intercept Pharmaceuticals, Inc.
) shares fell approximately 11.9% on Mar 17 following
dissapointing fourth quarter 2013 financial results and pipeline
related news. The company reported an adjusted loss of 72 cents
per share for the fourth quarter, wider than the Zacks Consensus
Estimate of a loss of 60 cents and the year-ago loss of 43 cents
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More than the wider loss, it was the company's statement about
the occurrence of cardiovascular serious adverse events in its
FLINT (Farnesoid X Receptor Ligand Obeticholic Acid in
Nonalcoholic Steatohepatitis Treatment) study which caused the
shares to tumble. The phase II study is evaluating the efficacy
and safety of Intercept Pharma's pipeline candidate, obeticholic
acid (OCA), compared to placebo, for the treatment of
nonalcoholic steatohepatitis (NASH). The study is being sponsored
and conducted by the National Institute of Diabetes &
Digestive & Kidney Diseases (NIDDK).
As per a recent safety data from NIDDK, 10 serious cardiovascular
adverse events were observed in 7 patients across both treatment
groups. The Data Safety Monitoring Board (DSMB) of the FLINT
study stated that hyperlipidemia and the occurrence of serious
cardiovascular events were numerically more in the OCA arm of the
study compared to that of the placebo arm. Full results from the
FLINT study are expected in Jul 2014.
Intercept Pharma intends to discuss the FLINT study results with
the regulatory authorities in the U.S. and EU to begin a phase
III program on OCA in the NASH indication in the first half of
2015. We are disappointed by the study findings. OCA is the lead
candidate at Intercept Pharma. The successful development and
commercialization of the candidate is important for the company.
Meanwhile, Intercept Pharma reported positive results from its
other study, the phase III POISE study on OCA. The POISE study is
evaluating OCA for the treatment of primary biliary cirrhosis
(PBC). Results from the study revealed that the candidate met its
primary objective of a reduction in serum alkaline phosphatase
from baseline and a normal bilirubin level post 12 months of
therapy. Intercept Pharma intends to file regulatory applications
for OCA in the PBC indication in both the U.S. and EU by the end
We believe that updates regarding OCA's development in the NASH
indication are of greater interest to investors. In January this
year, shares of Intercept Pharma surged a whopping 281% after the
company announced that the FLINT study was stopped early as it
met its primary endpoint.
Intercept Pharma currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the same sector include
Alexion Pharmaceuticals, Inc.
Gilead Sciences Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).