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 that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid(UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
“Intercept was founded on the belief that targeting FXR would benefit patients with liver diseases for which there are limited or no treatment options, and Ocaliva’s approval marks the culmination of more than a decade of work,” said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept. “We are very pleased that the FDA has approved Ocaliva for PBC and would like to thank all the patients and investigators around the world who participated in our clinical trials to make this possible.”
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
“Ocaliva fills an important unmet need for the many patients with PBC who have an inadequate response to or are intolerant of UDCA, which until now has been the only approved treatment,” said John Vierling, M.D., F.A.C.P., F.A.A.S.L.D., Professor of Medicine and Surgery at Baylor College of Medicine and Past President of the American Association for the Study of Liver Diseases (AASLD). “Ocaliva has demonstrated a clinically meaningful improvement in lowering ALP, a liver enzyme and biomarker that is used to track disease progression in patients with PBC. Importantly, Ocaliva maintained durable ALP reductions, which is critical for treatment of a chronic disease like PBC.”
In Intercept’s Phase 3 POISE trial, Ocaliva administration in combination with UDCA (or as monotherapy in UDCA-intolerant patients) met the primary composite endpoint in 46% of patients in the titration group, as compared to 10% of those receiving placebo added to UDCA (p<0.0001). Pruritus (itching), a common symptom of PBC that is unrelated to disease stage or outcomes, was the most common side effect observed in Ocaliva-treated patients. However, pruritus associated with Ocaliva treatment was generally less in patients who were on the dose titration regimen (5 mg once-daily increasing to 10 mg once-daily); one patient (1%) in the titration group discontinued from the study due to pruritus. Additional side effects observed during the trial included fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality and eczema.
“PBC affects people in the prime of their lives and, for some, the potential need for a liver transplant is a constant concern during these important years,” said Linie Moore, a PBC patient and President of the PBCers Organization, the leading PBC patient support group in the U.S. “After nearly two decades with only one approved treatment, we are thrilled to welcome this important new medicine for people living with PBC.” (Original Source)
Shares of Intercept Pharmaceuticals are up over 9% in pre-market trading. ICPT has a 1-year high of $285 and a 1-year low of $89.76. The stock’s 50-day moving average is $143.28 and its 200-day moving average is $138.09.
On the ratings front, Intercept has been the subject of a number of recent research reports. In a report issued on May 19, Needham analyst Alan Carr reiterated a Buy rating on ICPT, with a price target of $350, which represents a potential upside of 146.9% from where the stock is currently trading. Separately, on May 10, Oppenheimer’s Carlos Solorzano reiterated a Buy rating on the stock and has a price target of $265.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Alan Carr and Carlos Solorzano have a total average return of 10.8% and 3.3% respectively. Carr has a success rate of 45.0% and is ranked #209 out of 3869 analysts, while Solorzano has a success rate of 28.6% and is ranked #1965.
Overall, 2 research analysts have rated the stock with a Sell rating, 3 research analysts have assigned a Hold rating and 10 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 $211.78 which is 49.4% above where the stock closed yesterday.
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.