bluebird bio Announces the Lifting of FDA Clinical Hold for Sickle Cell Disease and ß-Thalassemia Studies
bluebird bio, Inc. (BLUE)
Last bluebird bio, inc. earnings: 2/18 04:05 pm
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Source: Business Wire
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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™ in the EU and the UK) 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.“Patient safety continues to be our utmost priority, and we are grateful for the close partnership with the FDA, investigators, scientists and most importantly, patients, who all contributed to the assessments of the adverse events in HGB-206 that ultimately led to today’s a
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BLUE
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- 11/7/23 - Beat
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