bluebird bio, Inc. (NASDAQ:BLUE) Files An 8-K Other Events
Item 8.01Other Events.

On March 29, 2019, bluebird bio, Inc. (“bluebird”) issued a press release to announce that it received a positive opinion recommending conditional marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for ZYNTEGLO (autologous CD34+ cells encoding β^A-T87Q-globin gene) for patients 12 years and older with transfusion-dependent β-thalassemia who do not have a β^{/ β genotype.}

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 9.01Financial Statements and Exhibits.

(d) Exhibits

bluebird bio, Inc. Exhibit
EX-99.1 2 blue-ex991_6.htm EX-99.1 blue-ex991_6.htm     Exhibit 99.1   bluebird bio Receives Positive Opinion from CHMP for ZYNTEGLO™ (autologous CD34+ cells encoding β A-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older with Transfusion-Dependent β-Thalassemia (TDT) Who Do Not Have β0/β0 Genotype First gene therapy recommended for approval in the EU for TDT Treatment with ZYNTEGLO has been shown to help eliminate the need for chronic blood transfusions in patients with TDT ZYNTEGLO is bluebird bio’s first gene therapy submitted for regulatory approval   CAMBRIDGE,…
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About bluebird bio, Inc. (NASDAQ:BLUE)

bluebird bio, Inc. is a biotechnology company. The Company is focused on developing transformative gene therapies for severe genetic and rare diseases and in the field of T cell-based immunotherapy. Its gene therapy clinical programs include LentiGlobin product candidate to treat transfusion-dependent B-thalassemia (TDT) and severe sickle cell disease (SCD), and Lenti-D product candidate to treat cerebral adrenoleukodystrophy (CALD), a rare hereditary neurological disorder. Its oncology programs are built using lentiviral gene delivery and T cell engineering, with a focus on developing T cell-based immunotherapies, including chimeric antigen receptor (CAR) and T cell receptor (TCR) T cell therapies. Its oncology program, bb2121, is a CAR T cell product candidate targeting B-cell maturation antigen, or BCMA, in multiple myeloma. It also offers discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies for use across its pipeline.