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bluebird (BLUE) Down on Suspension of Sickle Cell Disease Studies
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Shares of bluebird bio, Inc. (BLUE - Free Report) plunged about 38% after it announced the temporary suspension ofits phase I/II (HGB-206) and phase III (HGB-210) studies of LentiGlobin gene therapy insickle cell disease (SCD) because of reported Suspected Unexpected Serious Adverse Reactions (SUSARs) of acute myeloid leukemia (AML).The stock has also plunged 68.2% in the past year against the industry’s increase of 12.9%.
We note that the phase I/II HGB-206open-label study was designed to evaluate the efficacy and safety of LentiGlobin gene therapy for sickle cell disease (SCD) that includes three treatment cohorts — Groups A, B and C. HGB-210 was a phase III single-arm open-label study designed to evaluate the efficacy and safety of LentiGlobin gene therapy in SCD patients between two years and 50 years of age.
This suspension comes after a patient who was treated more than five years ago in Group A of HGB-206 was diagnosed with AML. The company is investigating the cause of this patient’s AML in order to determine if there is any relationship with the use of BB305 lentiviral vector in the manufacture of LentiGlobin gene therapy for SCD. In addition, a second SUSAR of myelodysplastic syndrome (MDS) in a patient from Group C of HGB-206 was reported and the company is currently investigating the same.
Moreover, bluebird also noted that it will further suspend the marketing of betibeglogene autotemcel for transfusion-dependent β-thalassemia (Zyntelgo) since it is manufactured with the same BB305 lentiviral vector, which is used in LentiGlobin gene therapy for SCD.
The independent safety review board monitoring the company’s studies as well as the FDA and the European Medicines Agency (EMA) have been advised of these cases and bluebird will continue working with regulatory agencies to complete its investigation.
LentiGlobin gene therapy is an investigational treatment being studied as a potential treatment for SCD. bluebird’s clinical development program for LentiGlobin for SCD includes the completed phase I/II HGB-205 study. bluebird is conducting a long-term safety and efficacy follow-up study (LTF-307) for people who have participated in bluebird-sponsored clinical studies of LentiGlobin for SCD.
Zacks Rank & Stocks to Consider
bluebird currently carries a Zacks Rank #4 (Sell).
Acorda’s loss per share estimates have narrowed from $9.66 to $7.91 for 2020 over the past 60 days.
Atea’s earnings per share estimates have increased from $3.53 to $3.70 for 2021 over the past 60 days. Shares of the company have increased 177.4% in the past year.
Clearside’s loss per share estimates have narrowed from 3 38 cents to 28 cents for 2021 over the past 60 days. Shares of the company have increased 46.2% in the past year.
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bluebird (BLUE) Down on Suspension of Sickle Cell Disease Studies
Shares of bluebird bio, Inc. (BLUE - Free Report) plunged about 38% after it announced the temporary suspension ofits phase I/II (HGB-206) and phase III (HGB-210) studies of LentiGlobin gene therapy insickle cell disease (SCD) because of reported Suspected Unexpected Serious Adverse Reactions (SUSARs) of acute myeloid leukemia (AML).The stock has also plunged 68.2% in the past year against the industry’s increase of 12.9%.
We note that the phase I/II HGB-206open-label study was designed to evaluate the efficacy and safety of LentiGlobin gene therapy for sickle cell disease (SCD) that includes three treatment cohorts — Groups A, B and C. HGB-210 was a phase III single-arm open-label study designed to evaluate the efficacy and safety of LentiGlobin gene therapy in SCD patients between two years and 50 years of age.
This suspension comes after a patient who was treated more than five years ago in Group A of HGB-206 was diagnosed with AML. The company is investigating the cause of this patient’s AML in order to determine if there is any relationship with the use of BB305 lentiviral vector in the manufacture of LentiGlobin gene therapy for SCD. In addition, a second SUSAR of myelodysplastic syndrome (MDS) in a patient from Group C of HGB-206 was reported and the company is currently investigating the same.
Moreover, bluebird also noted that it will further suspend the marketing of betibeglogene autotemcel for transfusion-dependent β-thalassemia (Zyntelgo) since it is manufactured with the same BB305 lentiviral vector, which is used in LentiGlobin gene therapy for SCD.
The independent safety review board monitoring the company’s studies as well as the FDA and the European Medicines Agency (EMA) have been advised of these cases and bluebird will continue working with regulatory agencies to complete its investigation.
LentiGlobin gene therapy is an investigational treatment being studied as a potential treatment for SCD. bluebird’s clinical development program for LentiGlobin for SCD includes the completed phase I/II HGB-205 study. bluebird is conducting a long-term safety and efficacy follow-up study (LTF-307) for people who have participated in bluebird-sponsored clinical studies of LentiGlobin for SCD.
Zacks Rank & Stocks to Consider
bluebird currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare sector include Acorda Therapeutics Inc. , Atea Pharmaceuticals Inc. (AVIR - Free Report) and Clearside Biomedical Inc. (CLSD - Free Report) . All of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Acorda’s loss per share estimates have narrowed from $9.66 to $7.91 for 2020 over the past 60 days.
Atea’s earnings per share estimates have increased from $3.53 to $3.70 for 2021 over the past 60 days. Shares of the company have increased 177.4% in the past year.
Clearside’s loss per share estimates have narrowed from 3 38 cents to 28 cents for 2021 over the past 60 days. Shares of the company have increased 46.2% in the past year.
bluebird bio, Inc. Price
bluebird bio, Inc. price | bluebird bio, Inc. Quote
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