NEW YORK (TheStreet) -- Intercept Pharmaceuticals (ICPT) fell on Monday after the company missed on full-year earnings per share and disclosed cardiac adverse events in a study of fatty liver disease patients tied to the company's experimental drug OCA.
The company disclosed the events in a regulatory filing late Friday. Here is the pertinent portion:
"We recently received a report of blinded FLINT safety data from the NIDDK and have learned that as of the end of December 2013 a total of ten cardiovascular serious adverse events had occurred in seven (2.5%) of the patients in FLINT across both treatment groups, at which point 207 (73%) patients had completed the 72-week treatment phase and 73 remaining patients had all been on study for 60 weeks or more. As part of its review, the trial's DSMB expressed concern regarding hyperlipidemia and the occurrence of serious cardiovascular events, both of which were seen in both the treatment and placebo groups, but disproportionately in patients receiving OCA. However, the NIDDK has advised us that while the incidence of the serious cardiovascular events was numerically higher in the patients receiving OCA therapy, it was not statistically significantly different as compared to the placebo group."
Intercept also reported a net loss of $3.76 a share for the full fiscal year 2013, which was 3 cents wider than the Capital IQ consensus estimate of $3.73.