bluebird bio, Inc. announced the U.S. Food and Drug Administration (FDA) has approved LYFGENIA?? (lovotibeglogene autotemcel), also known as lovo-cel, for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events (VOEs). This approval also marks bluebird's third ex vivo gene therapy approved by the FDA for a rare genetic disease and second FDA approval for an inherited hemoglobin disorder, cementing position as a gene therapy leader.

LYFGENIA will be available at bluebird bio's established network of Qualified Treatment Centers (QTCs), which receive specialized training to administer complex gene therapies like LYFGENIA. Information on bluebird's QTC network, as well as personalized support focused on the needs of each patient throughout their treatment journey, is available through bluebird's patient support program, my bluebird support. As previously reported, three patients died during LYFGENIA clinical trials; one from sudden cardiac death due to underlying disease and two from acute myeloid leukemia who were treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure.

At the time of initial product approval, two patients treated with an earlier version ofLYFGENIA using a new manufacturing process and transplant procedure (Study 1, Group A) developed acute myeloid leukemia (AML). Post-Marketing Long Term Follow-Up Study: Patients who intend to receive treatment with LYFGENIA are encouraged to enroll in the study, as available, to assess the long-term safety of LYFGENIA and the risk of malignancies occurring after treatment with LYFGENia by calling bluebird bio at 1-833-999-6378. Patients who have received LYFGENIA are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a possible false-positive PCR assay test result for HIV.

Three patients died during LYFGenIA clinical trials; one from quick cardiac death due to underlying disease, and two from acute myeloids leukemia who were treated with an later version of LYFGENia using a different manufacturing process and transpl procedure (Study 1, GroupA). All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements, such as statements regarding the therapeutic potential of LYFGENIA, including the transformative and potentially curative impact it may have for patients; the commercialization of LYFGENia, including without limitation, its availability, and the timing thereof, at QTCs; and the availability of services offered by my bluebird support program to support patient treatment. These risks and uncertainties include, but are not limited to: delays and challenges in bluebird's commercialization and manufacturing of its products; the internal and external costs required for bluebird's ongoing and planned activities, and the resulting impact on expense and use of cash, has been, and may in the future be, higher than than than than than than than the first half of the year.