This morning biopharmaceutical company Intercept Pharmaceuticals Inc. (ICPT:NASDAQ), which is engaged in the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, announced that "the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH) and granted priority review."
The company advised in the report that the FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 26, 2020, for the NDA. The firm noted that the NDA is supported by positive interim analysis results from the company's Phase 3 REGENERATE study demonstrating OCA's improvement of liver fibrosis without worsening of NASH, and that "the FDA grants priority review to drugs that have the potential to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness." The company indicated that the REGENERATE Study is a Phase 3, randomized study of obeticholic acid (OCA) on more than 2,400 adult NASH patients worldwide.
Intercept's President and CEO Mark Pruzanski, M.D., commented, "If approved, OCA would be the first available therapy for patients with fibrosis due to NASH, a condition that is expected to become the leading cause of liver transplant in the U.S. as soon as 2020...It is exciting to achieve this critical regulatory milestone that brings us one step closer to our goal of delivering the first approved therapeutic to those living with this devastating disease. From OCA's prior designation as a Breakthrough Therapy to the grant of priority review today, our work with FDA continues to set an important precedent for the field, and we look forward to working with the agency over the coming months as they review the first NDA in NASH."
The firm explains in the report that "nonalcoholic steatohepatitis (NASH) is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death."
Intercept states that "OCA is the only investigational therapy to have received Breakthrough Therapy designation from the FDA for NASH with fibrosis, and that the NDA filing for OCA is supported by positive interim analysis results from the pivotal Phase 3 REGENERATE study in patients with liver fibrosis due to NASH."
Intercept Pharmaceuticalsis a biopharmaceutical company headquartered in New York, NY. The firm operates in the U.S., Canada and Europe and is focused on the development and commercialization of therapeutics to treat non-viral, progressive liver diseases. These disease include primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).
Intercept has a market capitalization of approximately $2.9 billion with about 32.73 million shares outstanding along with a short interest of around 17.2%. ICPT shares opened today at $93.50 (+4.61, +5.19%) over Friday's closing price of $88.89. The stock has traded today between $93.11 to $100.00 per share and is currently trading at $96.00 (+$7.11, 8.00%).[NLINSERT]
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