Intercept Pharmaceuticals (ICPT) - Get Report shares on Monday tumbled after the U.S. Food and Drug Administration declined to clear for marketing the drug developer's therapy for a progressive liver disease.
Shares of the New York company at last check were down 37% to $48.45.
The FDA said the predicted benefit of obeticholic acid to treat liver fibrosis due to nonalcoholic steatohepatitis "remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval" to treat patients with the disorder, Intercept said.
NASH, a chronic disease related to obesity, is triggered by the buildup of fat in the liver and can result in liver failure, cancer and death.
The disease affects around 25% of Americans and Reuters reported that some analysts expect the market for NASH drugs to reach up to $35 billion as obesity rates climb.
“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," Intercept President and Chief Executive Mark Pruzanski said in a statement.
Pruzanski added that "we strongly believe that the totality of data submitted to date both meet the requirements of the Agency’s own guidance and clearly support the positive benefit-risk profile of OCA."
The new-drug-application submission for OCA is the first for NASH and was based on data from 35 clinical trials and more than 1,700 NASH patients treated with the drug, Intercept said.
"On behalf of the hepatology community, we are very concerned that the agency’s apparently still evolving expectations will make it exceedingly challenging to bring innovative therapies to NASH patients with high unmet medical need," Pruzanski said.