Shares of Intercept Pharmaceuticals Inc (NASDAQ: ICPT) crashed around 40% on Monday after the U.S. Food and Drug Administration (FDA) rejected the firm’s treatment for progressive liver disease.
The FDA has asked for additional data from an ongoing late-stage trial to support Intercept’s claim that obeticholic acid (OCA) is effective.
“Based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH,” the pharma company said in a statement.
Intercept called the FDA’s decision “premature” that was made based on an “incomplete review”.
“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,” said Mark Pruzanski, M.D., President and CEO of Intercept.
Intercept share price collapsed 40% to trade below the $45 mark for the first time since 2013.