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Global Blood's (GBT) MAA for Oxbryta Accepted in Europe
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Global Blood Therapeutics, Inc. announced that the European Medicines Agency (EMA) has completed the validation of its Marketing Authorization Application (MAA) for Oxbryta (voxelotor) tablets and started its standard review process. GBT is seeking full marketing approval from the EMA for Oxbryta to treat hemolytic anemia in patients with sickle cell disease (SCD) who are 12 years of age and older. SCD is a chronic, inherited blood disorder that affects hemoglobin levels.
Shares of Global Blood have declined 25.8% in the past year against the industry’s growth of 16.6%.
The MAA is supported by results from the phase III HOPE study and the phase II HOPE-KIDS 1 study, both of which enrolled patients at clinical sites in Europe. The HOPE Study achieved its primary endpoint of an improvement in hemoglobin (Hb) levels of greater than 1 g/dL at week 24,with significant improvements in markers of hemolysis in indirect bilirubin and reticulocyte percentage. The study showed that Oxbryta, at a daily dose of 1500 mg, resulted in durable improvements in Hb levels and markers of hemolysis over 72 weeks of treatment in SCD patients aged 12 years or older.
Oxbryta has been granted the Priority Medicines (PRIME) designation bythe EMA and the European Commission (EC) has designated Oxbryta as an orphan medicinal product for the treatment of patients with SCD.
We note that Oxbryta is approved by the FDA as an oral, once-daily treatment for SCD in patients aged 12 years or above.
The company plans to get Oxbryta approved in the United States for the treatment of SCD in children as young as 4 years old.
Zacks Rank and Stocks to Consider
Global Bloodcurrently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the healthcare sector include Acorda Therapeutics Inc. , Anavex Life Sciences Corp. (AVXL - Free Report) and Alexion Pharmaceuticals Inc. . While Acorda sports a Zacks Rank #1 (Strong Buy), Anavex and Alexion carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.
Anavex’s loss per share estimates have narrowed from 48 cents to 46 cents for 2021 over the past 60 days. Shares of the company have increased 103% in the past year.
Alexion’s earnings per share estimates have increased from $12.04 to $12.06 for 2020 over the past 60 days. Shares of the company have increased 45.6% in the past year.
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Global Blood's (GBT) MAA for Oxbryta Accepted in Europe
Global Blood Therapeutics, Inc. announced that the European Medicines Agency (EMA) has completed the validation of its Marketing Authorization Application (MAA) for Oxbryta (voxelotor) tablets and started its standard review process. GBT is seeking full marketing approval from the EMA for Oxbryta to treat hemolytic anemia in patients with sickle cell disease (SCD) who are 12 years of age and older. SCD is a chronic, inherited blood disorder that affects hemoglobin levels.
Shares of Global Blood have declined 25.8% in the past year against the industry’s growth of 16.6%.
The MAA is supported by results from the phase III HOPE study and the phase II HOPE-KIDS 1 study, both of which enrolled patients at clinical sites in Europe. The HOPE Study achieved its primary endpoint of an improvement in hemoglobin (Hb) levels of greater than 1 g/dL at week 24,with significant improvements in markers of hemolysis in indirect bilirubin and reticulocyte percentage. The study showed that Oxbryta, at a daily dose of 1500 mg, resulted in durable improvements in Hb levels and markers of hemolysis over 72 weeks of treatment in SCD patients aged 12 years or older.
Oxbryta has been granted the Priority Medicines (PRIME) designation bythe EMA and the European Commission (EC) has designated Oxbryta as an orphan medicinal product for the treatment of patients with SCD.
We note that Oxbryta is approved by the FDA as an oral, once-daily treatment for SCD in patients aged 12 years or above.
The company plans to get Oxbryta approved in the United States for the treatment of SCD in children as young as 4 years old.
Zacks Rank and Stocks to Consider
Global Bloodcurrently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the healthcare sector include Acorda Therapeutics Inc. , Anavex Life Sciences Corp. (AVXL - Free Report) and Alexion Pharmaceuticals Inc. . While Acorda sports a Zacks Rank #1 (Strong Buy), Anavex and Alexion carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.
Anavex’s loss per share estimates have narrowed from 48 cents to 46 cents for 2021 over the past 60 days. Shares of the company have increased 103% in the past year.
Alexion’s earnings per share estimates have increased from $12.04 to $12.06 for 2020 over the past 60 days. Shares of the company have increased 45.6% in the past year.
Global Blood Therapeutics, Inc. Price
Global Blood Therapeutics, Inc. price | Global Blood Therapeutics, Inc. Quote
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