Horizon Pharma plc announced that it has filed a supplemental new drug application with the FDA seeking label expansion for Ravicti (glycerol phenylbutyrate) oral liquid. The company is looking to expand the age range for chronic management of urea cycle disorders (UCDs) in adult and pediatric patients from two months of age to two years of age and older. The company’s shares jumped 6.9% on the news.
Currently, Ravicti is approved in the U.S. for use as a nitrogen-binding agent for chronic management of adult and pediatric patients greater than two years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation.
We are encouraged by Horizon Pharma’s efforts to expand Ravicti’s label further. We note that Ravicti became a part of the company’s portfolio as a result of the May 2015 Hyperion Therapeutics acquisition.
Ravicti recorded sales of $37.1 million in the first quarter of 2016. Label expansion would boost the drug’s sales further.
Additionally, Horizon Pharma partnered with Clinigen Group's Idis Managed Access division to initiate a Managed Access Program (MAP) in select European countries for eligible, individual patients living with UCDs. The MAP will allow healthcare professionals to access Ravicti while Horizon Pharma works through its country-by-country plan to make Ravicti commercially available in Europe. We note that Ravicti was approved in Europe in Nov 2015.
Horizon Pharma is currently a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Retrophin, Inc. and Bristol-Myers Squibb Company (BMY - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).
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It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
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Horizon Pharma plc announced that it has filed a supplemental new drug application with the FDA seeking label expansion for Ravicti (glycerol phenylbutyrate) oral liquid. The company is looking to expand the age range for chronic management of urea cycle disorders (UCDs) in adult and pediatric patients from two months of age to two years of age and older. The company’s shares jumped 6.9% on the news.
Currently, Ravicti is approved in the U.S. for use as a nitrogen-binding agent for chronic management of adult and pediatric patients greater than two years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation.
We are encouraged by Horizon Pharma’s efforts to expand Ravicti’s label further. We note that Ravicti became a part of the company’s portfolio as a result of the May 2015 Hyperion Therapeutics acquisition.
Ravicti recorded sales of $37.1 million in the first quarter of 2016. Label expansion would boost the drug’s sales further.
Additionally, Horizon Pharma partnered with Clinigen Group's Idis Managed Access division to initiate a Managed Access Program (MAP) in select European countries for eligible, individual patients living with UCDs. The MAP will allow healthcare professionals to access Ravicti while Horizon Pharma works through its country-by-country plan to make Ravicti commercially available in Europe. We note that Ravicti was approved in Europe in Nov 2015.
Horizon Pharma is currently a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Retrophin, Inc. and Bristol-Myers Squibb Company (BMY - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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