Bluebird Bio: FDA Lifts Clinical Hold On Sickle Cell Disease And ?-Thalassemia Studies - Quick Facts

(RTTNews) - bluebird bio, Inc. (BLUE) announced Monday 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.

The FDA also lifted the Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of betibeglogene autotemcel gene therapy 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.