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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