Item 8.01 Other Events.

On May 21, 2021, bluebird bio, Inc. ("bluebird") issued a press release to announce that it received a positive opinion recommending marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for SKYSONA™ (elivaldogene autotemcel, Lenti-D™), a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell (HSC) donor is not available.

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 May 21, 2021.
      104             Cover Page Interactive Data File (embedded within the Inline XBRL document)

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