New York-based Intercept Pharmaceuticals, Inc. focused on bringing novel therapeutics to treat chronic liver diseases to market.
Intercept received a major boost with the FDA approval (in May 2016) of its lead drug, 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 unable to tolerate UDCA.
The FDA has approved Ocaliva under its accelerated approval program based on a reduction in alkaline phosphatase (ALP), since an improvement in survival or disease-related symptoms has not been established yet. Continued approval in this indication may be contingent upon the verification and description of clinical benefit in confirmatory studies.
A marketing authorisation application for Ocaliva is currently under review in the EU. The European Medicines Authority’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval of Ocaliva. A final decision on the approval status should be out by 2016 end.
Intercept’s track record has been decent so far, with the company surpassing expectations in three of the last four quarters with an average earnings surprise of +7.13%.
Currently, Intercept Pharma has a Zacks Rank #3 (Hold), but that could definitely change following the company’s earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:
Earnings: Our consensus called for a loss of $3.72, while the company reported a loss of $3.59.
Revenue: Intercept Pharma posted revenues of $5.2 million compared to our consensus estimate of $5.6 million.
Key Stats: Intercept launched Ocaliva in June 2016 and the initial uptake of the drug has been encouraging. Ocaliva sales came in at $4.7 million in the third quarter.
Check back later for our full write up on Intercept’s earnings report later!
Confidential from Zacks
Beyond this Tale of the Tape, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>
Image: Bigstock
Intercept (ICPT) Reports Narrower-Than-Expected Q3 Loss
New York-based Intercept Pharmaceuticals, Inc. focused on bringing novel therapeutics to treat chronic liver diseases to market.
Intercept received a major boost with the FDA approval (in May 2016) of its lead drug, 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 unable to tolerate UDCA.
The FDA has approved Ocaliva under its accelerated approval program based on a reduction in alkaline phosphatase (ALP), since an improvement in survival or disease-related symptoms has not been established yet. Continued approval in this indication may be contingent upon the verification and description of clinical benefit in confirmatory studies.
A marketing authorisation application for Ocaliva is currently under review in the EU. The European Medicines Authority’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval of Ocaliva. A final decision on the approval status should be out by 2016 end.
Intercept’s track record has been decent so far, with the company surpassing expectations in three of the last four quarters with an average earnings surprise of +7.13%.
Currently, Intercept Pharma has a Zacks Rank #3 (Hold), but that could definitely change following the company’s earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:
Earnings: Our consensus called for a loss of $3.72, while the company reported a loss of $3.59.
Revenue: Intercept Pharma posted revenues of $5.2 million compared to our consensus estimate of $5.6 million.
Key Stats: Intercept launched Ocaliva in June 2016 and the initial uptake of the drug has been encouraging. Ocaliva sales came in at $4.7 million in the third quarter.
INTERCEPT PHARM Price and EPS Surprise
INTERCEPT PHARM Price and EPS Surprise | INTERCEPT PHARM Quote
Check back later for our full write up on Intercept’s earnings report later!
Confidential from Zacks
Beyond this Tale of the Tape, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>