Shares of Intercept Pharmaceuticals Inc. (ICPT) rose Tuesday after the biotech company unveiled successful Phase 3 test results for a new liver disease drug.
Intercept's stock price was rising 6.4% to $117.88. The surge came after the New York-based drug development company announced that its obeticholic acid treatment, or OCR, for patients with liver fibrosis due to NASH, or nonalcoholic steatohepatitis, had achieved its "primary endpoint demonstrating statistically significant improvement in liver fibrosis."
NASH is triggered by the build-up of fat in the liver and can result in liver failure and cancer and death.
More than 23% of NASH patients who received OCR showed significant improvement, compared to 11.9% who were given a placebo, the company said.
Intercept's treatment is the "only investigational drug to have received Breakthrough Therapy from the FDA" for showing promising results in battling NASH, the company said
Intercept now plans to file for approval for its new OCR drug in the second half of 2019 in both the U.S. and Europe.
"We are thrilled to report the first positive registrational Phase 3 study results in patients with NASH, a devastating disease that is on track to become a leading cause of liver transplant in coming years," said Dr. Mark Pruzanski, president and CEO of Intercept.