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08/17/22
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Price of ZYNTEGLO reflects potentially curative clinical benefit through achievement of durable transfusion independence and normal or near normal total hemoglobin levels Innovative outcomes-based contract offering includes single upfront payment and up to 80% risk-sharing ZYNTEGLO will be
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08/17/22
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ZYNTEGLO offers potentially curative benefit across ages and genotypes, through the achievement of durable transfusion independence and normal or near normal total hemoglobin levels Management team to host conference call Thursday, August 18 at 8:00 am ET SOMERVILLE, Mass. --(BUSINESS WIRE)--Aug.
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08/04/22
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- beti-cel for beta-thalassemia PDUFA goal date is set for August 19, 2022 - - eli-cel for cerebral adrenoleukodystrophy PDUFA goal date is set for September 16, 2022 - - Ended quarter with $218M in restricted cash, cash and cash equivalents and marketable securities - SOMERVILLE, Mass --(BUSINESS
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06/10/22
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Current standard of care relies on regular red blood cell transfusions and iron management that carry the risk of progressive multi-organ damage and increased risk of morbidity and mortality If approved, beti-cel will be the first potentially curative gene therapy option for people with
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06/09/22
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If approved, eli-cel will be the first and only gene therapy for the treatment of early active CALD, a rare neurodegenerative disease that primarily affects young children and leads to irreversible loss of neurologic function and death PDUFA goal date is set for September 16, 2022 SOMERVILLE, Mass.
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06/09/22
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- BLAs for beti-cel for beta-thalassemia and eli-cel for cerebral adrenoleukodystrophy, to be discussed at an FDA Advisory Committee Meeting on June 9-10, 2022 - SOMERVILLE, Mass. --(BUSINESS WIRE)--Jun. 9, 2022-- bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today announced
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06/07/22
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June 9 discussion will focus on eli-cel for the treatment of early active cerebral adrenoleukodystrophy in patients without a matched sibling donor and overall safety of lentiviral vector (LVV) gene therapy June 10 discussion will focus on beti-cel for the treatment of β-thalassemia in patients who
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05/09/22
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- BLAs for beti-cel for β-thalassemia and eli-cel for cerebral adrenoleukodystrophy, to be discussed at an FDA Advisory Committee Meeting on June 9-10, 2022 - - Company restructuring initiated in April to reduce operating costs by 35 to 40 percent by year-end 2022 - - Ended quarter with $312M in
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04/05/22
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Expected to deliver up to $160 million in cost savings over the next two years and extend the Company’s cash runway through pivotal upcoming milestones in the first half of 2023 Management team to host conference call today, April 5, 2022 at 8:00 am ET CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr.
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03/04/22
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- The Company’s first two gene therapies, beti-cel for β-thalassemia and eli-cel for cerebral adrenoleukodystrophy, under review by the FDA - - lovo-cel BLA submission for sickle cell disease remains on track for Q1 2023 - - Ended year with $442M in restricted cash, cash and cash equivalents and
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01/18/22
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FDA PDUFA goal dates for both therapies extended by three months CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jan. 18, 2022-- bluebird bio, Inc . (NASDAQ: BLUE) today announced that the US Food and Drug Administration (FDA) has extended the review period for the biologics licensing applications (BLA) for
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01/11/22
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jan. 11, 2022-- bluebird bio, Inc . (Nasdaq: BLUE) today announced planned updates to be presented at the 40 th Annual J.P. Morgan Healthcare conference including 2022 program milestones and financial outlook. In 2022, bluebird is focused on the FDA review of two
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01/05/22
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jan. 5, 2022-- bluebird bio, Inc . (Nasdaq: BLUE) today announced that members of the management team will present at the virtual 40 th Annual J.P. Morgan Healthcare Conference , Wednesday, January 12 , at 3:45 p.m. ET .
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