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bluebird (BLUE) Resumes SCD & TDT Studies as FDA Lifts Hold

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bluebird bio, Inc. (BLUE - Free Report) announced that the FDA lifted the clinical hold on the company’s clinical studies on gene therapies — LentiGlobin and betibeglogene autotemcel  — for treating sickle cell disease (SCD) and transfusion-dependent β-thalassemia (TDT), respectively.

Following the development, the company will now be able to resume phase I/II HGB-206 and phase III HGB-210 studies on LentiGlobin (bb1111) for the treatment of adult and pediatric patients with SCD. It will also resume the phase III Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies on betibeglogene autotemcel (beti-cel) for treating adult, adolescent and pediatric patients with TDT.

Shares of bluebird were up 3.4% on Monday, following the announcement of the above-mentioned news. However, the stock has plunged 26.1% so far this year compared with the industry’s decrease of 4%.

 

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We remind investors that in February 2021, bluebird announced a temporary suspension of its phase I/II (HGB-206) and phase III (HGB-210) studies of LentiGlobin gene therapy for SCD (bb1111) due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML).

As a result, the FDA placed a clinical hold on the HGB-206 and HGB-210 studies of LentiGlobin for SCD, and the HGB-207 and HGB-212 studies of beti-cel for β-thalassemia.

Subsequently, in March 2021, the company announced that it is very unlikely that the SUSAR of AML reported in its HGB-206 study of LentiGlobin for SCD was related to the BB305 lentiviral vector.

Notably, in 2019, the European Commission granted conditional marketing authorization for beti-cel (in patients aged 12 years or older, with transfusion-dependent β-thalassemia (TDT), who do not have a β0/β0 genotype and for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. It is marketed as Zynteglo.

bluebird remains on track to complete its rolling biologics license application submission to the FDA in mid-2021 for beti-cel.

Zacks Rank & Stocks to Consider

bluebird currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Repligen Corporation (RGEN - Free Report) , Kamada Ltd. (KMDA - Free Report) and Bio-Techne Corporation (TECH - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see  the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates have been revised 15.7% upward for 2021 and 14.7% upward for 2022 over the past 60 days.

Kamada’s earnings estimates have been revised 21.4% upward for 2021 and 18.1% upward for 2022 over the past 60 days.

Bio-Techne’s earnings estimates have been revised 8.8% upward for 2021 and 9.1% upward for 2022 over the past 60 days. The stock has gained 32.1% year to date.

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