Stock Alert: Intercept Pharmaceuticals Down 40%

(RTTNews) - Shares of Intercept Pharmaceuticals, Inc. (ICPT) are losing nearly 40% on Monday morning after the U.S. Food and Drug Administration declined to approve the drug maker's treatment for liver fibrosis.

ICPT is currently trading at $47.88, down $29.61 or 38.22%, on the Nasdaq.

In a Complete Response Letter, the FDA said that the predicted benefit of the treatment, obeticholic acid, or OCA, is uncertain and does not sufficiently outweigh the potential risks to support accelerated approval.

"The FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue," the company said in a statement.

Intercept CEO Mark Pruzanski said, "We are disappointed to see the determination the Agency has reached based on an apparently incomplete review, and without having provided medical experts and patients the opportunity to be heard at the anticipated Adcom on the merits of OCA, which is a designated Breakthrough Therapy."