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Jazz Begins Phase III Study for Label Expansion of Defitelio
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Jazz Pharmaceuticals Public Limited Company (JAZZ - Free Report) announced the initiation of a phase III clinical study on its marketed drug, Defitelio (defibrotide), for the potential prevention of veno-occlusive disease (VOD) in high-risk adult and pediatric patients.
Defitelio is currently available in the U.S. for the treatment of adult and pediatric patients with hepatic VOD with renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT). It is also approved in Europe for the treatment of severe VOD in adults and children undergoing HSCT therapy.
This randomized, open-label, multi-center trial has an adaptive design for comparing the efficacy of Defitelio with the best supportive care (BSC). The trial is expected to enroll approximately 400 adult and pediatric patients. The primary endpoint of the study is VOD-free survival at day +30 post HSCT.
Shares of Jazz Pharma have outperformed the Zacks classified Medical-Drugs industry in the past one month. The stock gained 7.9% during this period, better than the broader industry’s increase of 2.9%.
Defitelio became part of Jazz's portfolio following its Jan 2014 acquisition of Gentium.
Considering the lack of approved therapies for the treatment of patients suffering from hepatic VOD with evidence of multi-organ dysfunction (MOD) and a mortality rate of 84% associated with the disease, Jazz stated in its press release that there is significant unmet need in this market.
We expect investor focus to remain on the commercialization and sales ramp-up of Defitelio.
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics, Inc. (ANIK - Free Report) , Enzo Biochem, Inc. (ENZ - Free Report) and ARIAD Pharmaceuticals, Inc . 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.
Anika’s earnings estimates have increased from $2.06 to $2.14 for 2016 and from $2.09 to $2.10 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has increased 2.2% year to date.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2016 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
ARIAD’s loss estimates narrowed from 4 cents to 3 cents for 2016 and from 49 cents to 35 cents for 2017 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 171.37%.
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Jazz Begins Phase III Study for Label Expansion of Defitelio
Jazz Pharmaceuticals Public Limited Company (JAZZ - Free Report) announced the initiation of a phase III clinical study on its marketed drug, Defitelio (defibrotide), for the potential prevention of veno-occlusive disease (VOD) in high-risk adult and pediatric patients.
Defitelio is currently available in the U.S. for the treatment of adult and pediatric patients with hepatic VOD with renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT). It is also approved in Europe for the treatment of severe VOD in adults and children undergoing HSCT therapy.
This randomized, open-label, multi-center trial has an adaptive design for comparing the efficacy of Defitelio with the best supportive care (BSC). The trial is expected to enroll approximately 400 adult and pediatric patients. The primary endpoint of the study is VOD-free survival at day +30 post HSCT.
Shares of Jazz Pharma have outperformed the Zacks classified Medical-Drugs industry in the past one month. The stock gained 7.9% during this period, better than the broader industry’s increase of 2.9%.
Defitelio became part of Jazz's portfolio following its Jan 2014 acquisition of Gentium.
Considering the lack of approved therapies for the treatment of patients suffering from hepatic VOD with evidence of multi-organ dysfunction (MOD) and a mortality rate of 84% associated with the disease, Jazz stated in its press release that there is significant unmet need in this market.
We expect investor focus to remain on the commercialization and sales ramp-up of Defitelio.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC Price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Key Picks
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics, Inc. (ANIK - Free Report) , Enzo Biochem, Inc. (ENZ - Free Report) and ARIAD Pharmaceuticals, Inc . 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.
Anika’s earnings estimates have increased from $2.06 to $2.14 for 2016 and from $2.09 to $2.10 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has increased 2.2% year to date.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2016 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
ARIAD’s loss estimates narrowed from 4 cents to 3 cents for 2016 and from 49 cents to 35 cents for 2017 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 171.37%.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>