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Intercept (ICPT) Ocaliva Gains Conditional Approval in EU
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Intercept Pharmaceuticals, Inc. announced that the European Commission has granted conditional approval to Ocaliva, in combination with ursodeoxycholic (UDCA), for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to UDCA or as monotherapy in adults who are intolerant to UDCA.
Intercept’s year-to-date share price movement reveals that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. The company’s shares have lost 30.2% so far this year, which compares unfavorably with the industry’s 25.8% fall.
Coming back to the latest news, the EU approval did not come as a surprise as the European Committee for Medicinal Products for Human Use had issued a favorable opinion for a conditional marketing authorization of Ocaliva this October.
The approval was based on safety and efficacy data from three randomized double-blind, placebo-controlled studies to evaluate the effect of Ocaliva on alkaline phosphatase (ALP) and bilirubin in patients with PBC.
However, Intercept needs to provide post-approval data from the safety and efficacy analyses of the ongoing phase IV COBALT study and a short-term study in patients with hepatic impairment.
We remind investors that Ocaliva, in combination with UDCA, was approved in the U.S. in May 2016 for the abovementioned indication. The initial uptake of Ocaliva was encouraging. The drug generated sales of $4.7 million in the third quarter of 2016.
PBC affects approximately one in 1,000 women aged over 40 years. Hence, there is significant unmet need for therapies in this space.
Meanwhile, Intercept is evaluating Ocaliva for other indications including nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has surged almost 77% year to date.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has surged almost 14% year to date.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72% year to date.
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Intercept (ICPT) Ocaliva Gains Conditional Approval in EU
Intercept Pharmaceuticals, Inc. announced that the European Commission has granted conditional approval to Ocaliva, in combination with ursodeoxycholic (UDCA), for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to UDCA or as monotherapy in adults who are intolerant to UDCA.
Intercept’s year-to-date share price movement reveals that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. The company’s shares have lost 30.2% so far this year, which compares unfavorably with the industry’s 25.8% fall.
Coming back to the latest news, the EU approval did not come as a surprise as the European Committee for Medicinal Products for Human Use had issued a favorable opinion for a conditional marketing authorization of Ocaliva this October.
The approval was based on safety and efficacy data from three randomized double-blind, placebo-controlled studies to evaluate the effect of Ocaliva on alkaline phosphatase (ALP) and bilirubin in patients with PBC.
However, Intercept needs to provide post-approval data from the safety and efficacy analyses of the ongoing phase IV COBALT study and a short-term study in patients with hepatic impairment.
We remind investors that Ocaliva, in combination with UDCA, was approved in the U.S. in May 2016 for the abovementioned indication. The initial uptake of Ocaliva was encouraging. The drug generated sales of $4.7 million in the third quarter of 2016.
PBC affects approximately one in 1,000 women aged over 40 years. Hence, there is significant unmet need for therapies in this space.
Meanwhile, Intercept is evaluating Ocaliva for other indications including nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
INTERCEPT PHARM Price and Consensus
INTERCEPT PHARM Price and Consensus | INTERCEPT PHARM Quote
Intercept currently has Zacks Rank #3 (Hold).
Key Picks in the Sector
Some better-ranked stocks in the health care sector include Vanda Pharmaceuticals Inc. (VNDA - Free Report) Heska Corp. and Cambrex Corp. . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has surged almost 77% year to date.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has surged almost 14% year to date.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72% year to date.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>