Shares of drug maker Intercept Pharmaceuticals Inc (NASDAQ:ICPT) are in a freefall today. Why? An increased risk of serious liver injury and deaths for patients taking excessive doses of Intercept’s liver-disease medicine Ocaliva led the FDA to warn healthcare professionals and patients. Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose.
Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and destroyed. This causes bile, a fluid that helps in digestion, to build up in the liver. This build-up damages the liver over time, eventually causing it to lose its ability to function. Ocaliva has been shown to improve a certain blood test that measures liver problems.
Health care professionals should determine the patient’s baseline liver function prior to starting Ocaliva. Patients with moderate to severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly. Health care professionals should monitor patients frequently for disease progression, and reduce the dosing frequency to once- or twice-weekly for patients who progress to moderate or severe liver impairment. In all patients treated with Ocaliva, monitor frequently for liver injury (e.g., worsened liver blood tests and adverse liver-related reactions that may be inconsistent with the patient’s extent of disease). If liver injury is suspected, discontinue Ocaliva. After the patient has stabilized, weigh the benefits against the risks when deciding whether to re-initiate treatment. Educate patients on the symptoms of potential liver injury.
In the wake of the FDA warning, Intercept shares plunged over 20% to 52-week low of $78.51.
On the ratings front, ICPT has been the subject of a number of recent research reports. In a report issued on September 19, Citigroup analyst Joel Beatty maintained a Buy rating on ICPT, with a price target of $150, which implies an upside of 52% from current levels. On September 15, Wedbush’s Liana Moussatos reiterated a Buy rating on the stock as well.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joel Beatty and Liana Moussatos have a yearly average loss of 0.2% and a return of 9.4% respectively. Beatty has a success rate of 51% and is ranked #3330 out of 4658 analysts, while Moussatos has a success rate of 43% and is ranked #555.
Sentiment on the street is mostly bullish on ICPT stock. Out of 10 analysts who cover the stock, 8 suggest a Buy rating , one suggests a Sell and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $198.71, which implies an upside of 102% from current levels.
Intercept Pharmaceuticals is a biopharmaceutical company, which engages in the research, development, and commercialization of novel therapeutics in treating chronic liver diseases. Its product pipeline is OCALIVA which is used for the treatment of primary biliary cholangitis, nonalcoholic steatohepatitis, primary sclerosing cholangitis, and biliary atresia.