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bluebird bio Announces Lifting Of FDA Clinical Hold For Sickle Cell Disease And -Thalassemia Studies


Benzinga | Jun 7, 2021 08:03AM EDT

bluebird bio Announces Lifting Of FDA Clinical Hold For Sickle Cell Disease And -Thalassemia Studies

bluebird bio, Inc. (NASDAQ:BLUE) today announced 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(tm) in the EU and the UK) for adult, adolescent and pediatric patients with transfusion-dependent ?-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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