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Reports US

US stock market daily report (March 17, 2014, Monday)

March 18, 2014, Tuesday, 06:00 GMT | 02:00 EST | 10:30 IST | 13:00 SGT
Contributed by Millennium Traders

Intercept Pharmaceuticals, Inc. (ICPT-Nasdaq) shares were hammered on Monday, ending the session lower by 12% or down over $55 per share. Late Friday, the pharmaceutical firm released a new disclosure regarding cardiovascular side effects tied to their drug known as obeticholic acid (OCA) in a separate phase II study involving patients with fatty liver disease. Intercept downplayed the significance of the OCA heart-safety issue side effects in the company's 10-K which obvious is, a serious concern of investors.

The paragraph from the 10-K that shook investors confidence:
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.

In the POISE study, Intercept made no mention of cardiovascular adverse events. Other more serious adverse events were reported in OCA patients than placebo but none were considered drug related, per Intercept. The common adverse event reported in 56% to 68% of OCA patients compared to 38% of placebo patients was mild/moderate pruritus or skin itching.

OCA was associated with worsening cholesterol levels in a separate study in patients with fatty liver disease, stopped early for positive efficacy in January.