Shares of Intercept Pharmaceuticals Inc. soared in premarket trading Tuesday, a day after the drug developer said its most advanced candidate performed better than a placebo in a mid-stage study of patients with a form of chronic liver disease.
The New York company said it now plans to start late-stage clinical testing in the first half of next year for obeticholic acid, or OCA, as a possible treatment for nonalcoholic steatohepatitis, or NASH.
Late-stage testing is usually the final phase of clinical research before a company submits a drug to regulators for approval.
NASH is caused by excessive fat accumulation in the liver. It causes inflammation that can cause scarring that can lead to cirrhosis, liver failure, and death.
That condition remains "possibly the last untapped mega-blockbuster commercial setting" for drugmakers, Citi analyst Jonathan Eckard said in a Tuesday morning research note.
The analyst said the latest research update from Intercept led him to raise his probability for OCA's success in treating this condition to 80 percent from 75 percent.
Intercept is focused on developing drugs to treat chronic liver and intestinal diseases. It also plans to seek approval for OCA as a treatment for another chronic liver disease, primary biliary cirrhosis, in the United States and Europe in first half of next year.
Company shares were up 46 percent, or $108.82, to $346 in premarket trading about 30 minutes before the market open.