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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.


RTTNews | Jun 7, 2021 09:04AM EDT

09:03 Monday, June 7, 2021 (RTTNews.com) - 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 -thalassemia (TDT).

The company is working closely with study investigators and clinical trial sites to resume all study activities as soon as possible.

Read the original article on RTTNews ( https://www.rttnews.com/3200428/bluebird-bio-fda-lifts-clinical-hold-on-sickle-cell-disease-and--thalassemia-studies-quick-facts.aspx)

For comments and feedback: contact editorial@rttnews.com

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