Intercept Pharmaceuticals (ICPT) had surged about 25% in the pre-market session on Tuesday after the biopharma company announced positive topline results from the phase 3 study for the treatment of patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). Based on these results, Intercept intends to file for approval in the U.S. and Europe in the latter half of 2019.
Shares of Intercept traded down $0.38 on Friday and ended at $110.82. The stock, which hit a yearly high ($133.74) in early October, had surged about 25% in the pre-market trading today. The stock, which was expected to surpass its previous 52-week high today, didn’t carry the pre-market momentum and opened up 19% at $131.67.
“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 CEO Mark Pruzanski.
Also read: Intercept Pharmaceuticals (ICPT) Q3 2018 earnings call transcript
The company plans to present the study results at the European Association for the Study of the Liver (EASL): The International Liver Congress 2019, which is scheduled to take place 10-14 April 2019 in Vienna, Austria.
It’s worth noting that biotech giant Gilead Sciences (GILD) reported its failure of late-stage study in patients with compensated cirrhosis due to NASH. The NASH market is projected to experience rapid growth in the future and many pharma companies are investing heavily in this area.
According to DelveInsight, the NASH market will experience significant annual growth over the 2016-2028 study period, as major-market sales increase up to $30.1 billion by 2028. The report also states that Intercept’s OCA is expected to grab maximum market share.
Intercept’s peers Viking Therapeutics (VKTX) and CymaBay Therapeutics (CBAY) also jumped today in pre-market hours, buoyed by the positive data from the New York-based pharma company.