Item 8.01 Other Events.

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 ?-thalassemia (TDT). The Company is working closely with study investigators and clinical trial sites to resume all study activities as soon as possible.

The full text of bluebird's press release regarding the announcement is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.



(d) Exhibits

    Exhibit
      No.                                             Description
     99.1               Press release issued by bluebird bio, Inc. on June 7, 2021.
      104             Cover Page Interactive Data File (embedded within the Inline XBRL document)

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