In a research note issued Friday, Maxim analyst Jason McCarthy reiterated a Hold rating on shares of Valeant Pharmaceuticals Intl Inc (NYSE:VRX), after the company announced that Orkambi, has been approved in Europe for the treatment of Cystic Fibrosis patients 12 and older who are homozygous (two copies) for the F508del mutation. No price target was provided.

McCarthy observed, “Orkambi approval and a successful launch in both the U.S. (underway) and Europe (coming soon) is already factored into our model. We also assume that VX-661/ivacaftor will be successful in the heterozygous population. However, the question that still remains is: What is the risk of failure in heterozygotes? Multiple phase III studies should have data in 2016. Will it be positive? We’ll see, but for now we remain HOLD rated while we await data.”

The analyst continued, “With approval in the U.S. (July 2, 2015) and expected in Europe (early 2016), the focus is now on the launch trajectory. With up to 28,000 F508del homozygotes worldwide (20,000 combined in the U.S. and Europe), uptake could be impacted by the volume of patients, centers, and doctors creating an initial bottleneck. However, in 3Q15, Vertex has already treated 3,000 patients in the U.S., which suggests, at this rate, the first 8,500 U.S. CF patients eligible for Orkambi could be on the drug within six months”

According to, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Jason McCarthy has a total average return of -2.2% and a 40% success rate. McCarthy is ranked #2983 out of 3857 analysts.

Out of the 20 analysts polled by TipRanks, 13 rate Valeant Pharmaceuticals stock a Buy, 6 rate the stock a Hold and 1 recommends s Sell. With a return potential of nearly 85%, the stock’s consensus target price stands at $168.24.