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Monday, 06/07/2021 8:51:26 AM

Monday, June 07, 2021 8:51:26 AM

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On June 7, 2021, bluebird bio, Inc. (the "Company" or "bluebird") issued a press release to announce that the U.S. Food and Drug Administration (FDA) has lifted the clinical holds on the Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) for adult and pediatric patients with SCD, and the Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of betibeglogene autotemcel gene therapy (beti-cel; licensed as ZYNTEGLO™ in the European Union and the United Kingdom) for adult, adolescent and pediatric patients with transfusion-dependent ß-thalassemia (TDT). The Company is working closely with study investigators and clinical trial sites to resume all study activities as soon as possible.
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