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ICPT shares surged 300% in trading today after an analysis by an independent safety committee showed its liver disease drug met the main goal of a mid-stage trial. ICPT stock closed at $275.49, up 280.56% from Wednesday's closing price of $72.39. The stock climbed as high as $305 in intraday trading.
Boosting shares was speculation the 12-year-old company will be able to receive fast-track regulatory approval for its promising trial drug.
The New York-based development stage biopharmaceutical company, which focuses on the development and commercialization of novel therapies to treat chronic liver diseases, said a trial for its lead product candidate was halted early after the study already met its primary endpoint.
The trial, dubbed FLINT, was being conducted for obeticholic acid (OCA), a potential treatment for the chronic liver disease nonalcoholic steatohepatitis (NASH).
The decision to stop the trial followed the recommendation of the Data and Safety Monitoring Board, which reviewed liver biopsy data in half of the 283 trial patients. The analysis found Intercept's OCA treatment resulted in "highly statistically significant improvement."
Mark Pruzanski, M.D., chief executive officer of Intercept, said in a statement, "The unexpectedly early stopping of FLINT due to OCA meeting the primary endpoint with such high significance is a major milestone. NASH has grown to epidemic proportions worldwide, having become a leading cause of cirrhosis and liver failure. On its current trajectory, the disease is projected to become the leading indication for liver transplant."
If approved, patients receiving OCA could greatly reduce the risk of having to undergo a liver transplant.
A similar trial including 200 patients is currently being conducted in Japan by Intercept's collaborator Dainippon Sumitomo Pharma. Top-line results from the study are expected in 2015.