Stock Update (NASDAQ:ICPT): Intercept Pharmaceuticals Inc Files New Drug Submission to Health Canada for Marketing Approval of Obeticholic Acid for the Treatment of Patients with Primary Biliary Cholangitis

Intercept Pharmaceuticals Inc (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced the filing of a New Drug Submission to Health Canada, seeking Canadian marketing approval for obeticholic acid (OCA) for the treatment of primary biliary cholangitis, also referred to as primary biliary cirrhosis (PBC), when used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

“Our submission to Health Canada not only reflects a significant milestone for Intercept, but more importantly for the estimated 8,000 Canadians living with PBC, many of whom remain at risk of liver failure and need for transplantation despite the current standard of care,” said Dr. Mark Pruzanski, President & CEO of Intercept Pharmaceuticals. “We are pleased with Health Canada’s decision to grant OCA priority review status, recognizing the high unmet medical need for new therapies in PBC and the potential of OCA to offer meaningful benefits in improving outcomes for patients impacted by the disease.”

PBC is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. It is primarily a disease of women, affecting approximately one in 1,000 women over the age of 40. If left untreated, survival of patients with PBC is significantly worse than that of the general population.

Canadian researchers have played a significant role in advancing the clinical research and management of PBC. With seven clinical trial sites across the country participating in the OCA PBC clinical development program, Canadian clinicians, patients and health institutions have made a meaningful contribution to the development of OCA.

“Both patients and doctors have been looking forward to new avenues of treatment for PBC patients at risk of disease progression. We have made great inroads in understanding what may cause PBC but this has not really impacted patient care – for a rare disease there are too many patients with PBC waiting for liver transplantation,” said Dr. Andrew Mason, Director of Research for the Division of Gastroenterology and Hepatology at the University of Alberta. “In clinical trials, OCA made a significant and clinically meaningful impact on lab tests used to monitor biliary disease, such as alkaline phosphatase and bilirubin.  We are hopeful that OCA will be available soon for our patients with PBC.” (Original Source)

Shares of Intercept Pharmaceuticals closed last Friday at $157.2, up $4.28 or 2.80%. ICPT has a 1-year high of $217.99 and a 1-year low of $89.76. The stock’s 50-day moving average is $158.06 and its 200-day moving average is $146.56.

On the ratings front, ICPT stock has been the subject of a number of recent research reports. In a report issued on August 22, Wedbush analyst Liana Moussatos reiterated a Buy rating on ICPT, with a price target of $239, which implies an upside of 52% from current levels. Separately, on August 18, JMP’s Liisa Bayko reiterated a Buy rating on the stock.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Liana Moussatos and Liisa Bayko have a total average return of 10.9% and 15.9% respectively. Moussatos has a success rate of 41% and is ranked #243 out of 4163 analysts, while Bayko has a success rate of 59% and is ranked #206.

Overall, 3 research analysts have rated the stock with a Sell rating, one research analyst has assigned a Hold rating and 6 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $188.25 which is 19.8% above where the stock closed last Friday.

Intercept Pharmaceuticals, Inc. is a development stage biopharmaceutical company. It focuses on the discovering, developing and commercializing of novel therapeutics to treat chronic liver diseases utilizing its proprietary bile acid chemistry. It develops obeticholic acid, a bile acid analog that is in Phase III clinical trials for the treatment of primary biliary cirrhosis; in Phase IIa clinical trial to treat portal hypertension; in Phase II clinical trial for the treatment of alcoholic hepatitis; in Phase IIb clinical trial for the treatment of nonalcoholic steatohepatitis; and in Phase IIa clinical trial to treat bile acid diarrhea. 


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