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07/28/21
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Resilience to acquire bluebird’s clinical and commercial suspension lentiviral vector manufacturing facility in North Carolina , retaining all current employees at the site Alliance designed to foster best in class cell therapy product and manufacturing innovation through risk-sharing and
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07/21/21
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SKYSONA is the first and only gene therapy approved in the EU to treat early CALD CALD is a rare neurodegenerative disease that can lead to progressive, irreversible loss of neurologic function, and death One-time treatment with SKYSONA has been shown to have a durable effect in improving survival
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07/09/21
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EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) confirms favorable benefit-risk balance of ZYNTEGLO Company has informed EMA of lift of voluntary temporary marketing suspension CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jul. 9, 2021-- bluebird bio, Inc .
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06/11/21
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With 51 patients enrolled, data from the long-term follow-up study (LTF-303) show that all patients treated with beti-cel who achieve transfusion independence (TI) remain free from transfusions, with the longest follow-up of seven years Across Phase 3 studies, 89% (32/36) of evaluable patients
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06/07/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 7, 2021-- bluebird bio, Inc. (NASDAQ: BLUE) today announced that members of the management team will participate in the Goldman Sachs 42 nd Annual Global Healthcare Conference, Tuesday, June 8 , at 8:50 a.m. ET .
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06/07/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 7, 2021-- bluebird bio, Inc . (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical holds on the Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy
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06/02/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun. 2, 2021-- bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Compensation Committee of the Company’s Board of Directors approved inducement grants of stock options to purchase a total of 50,000 shares of common stock and 25,000 restricted stock units
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05/21/21
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SKYSONA is the first and only gene therapy recommended for approval for patients with CALD, a progressive, neurodegenerative disease As of the data cutoff date, 90% of patients (27/30) treated with SKYSONA in the pivotal ALD-102 clinical study met the primary endpoint of major functional disability
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05/19/21
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Data from pivotal KarMMa study to be presented at ASCO21 show 24.8-month median overall survival in triple-class exposed multiple myeloma With more than 24-month median follow-up, results represent longest follow-up to date from a global clinical trial of a CAR T cell therapy in multiple myeloma
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05/13/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 13, 2021-- bluebird bio, Inc . (Nasdaq: BLUE) announced today that data from its gene therapy programs for transfusion-dependent β-thalassemia (TDT) and sickle cell disease (SCD) and its cell therapy program for relapsed or refractory multiple myeloma (R/RMM)
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05/05/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 5, 2021-- bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the first quarter ended March 31, 2021 and shared recent operational progress. “Undoubtedly the highlight of last quarter at bluebird was the approval of
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05/03/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 3, 2021-- bluebird bio, Inc. (NASDAQ: BLUE) today announced that members of the management team will participate in the following upcoming investor conferences: BofA Securities 2021 Health Care Conference , Thursday, May 13 , at 9:30 am ET 2021 RBC Capital
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04/20/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr. 20, 2021-- bluebird bio, Inc. (Nasdaq: BLUE) announced today business and program updates across its severe genetic disease portfolio including a revised diagnosis for the previously reported case of myelodysplastic syndrome (MDS) in its Phase 1/2 study of
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04/14/21
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Single IV cycle of PsiOxus’ T-SIGn vector enabled an otherwise non-effective dose of CAR-T cell therapy to clear primary and metastatic tumors in vivo Reprogramming of the tumor microenvironment using T-SIGn vectors could enable a variety of CAR-T therapies to overcome limitations in solid tumors
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03/26/21
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Abecma is a first-in-class BCMA-directed personalized immune cell therapy delivered as a one-time infusion for triple-class exposed patients with multiple myeloma 1 In the pivotal KarMMa trial, the majority (72%) of patients achieved rapid, deep and durable responses 1 Safety profile of Abecma is
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03/15/21
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90% of evaluable patients (27/30) alive and free of major functional disabilities (MFDs) at two years follow-up in Phase 2/3 Starbeam study (ALD-102) Patients in long-term follow-up study (LTF-304) continue to remain alive and MFD-free through up to nearly seven years of follow-up, suggesting
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03/10/21
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Analyses demonstrate lentiviral vector BB305 unlikely to be the cause of AML in clinical study of LentiGlobin for SCD bluebird bio has initiated process with regulators to resume clinical studies Company to hold conference call and webcast today, March 10, 2021 , 8:00 AM EST CAMBRIDGE, Mass.
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02/26/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 26, 2021-- bluebird bio, Inc. (NASDAQ: BLUE) today announced that members of the management team will participate in the Cowen 41 st Annual Health Care Conference , Wednesday, March 3 , at 2:40 p.m. ET . To access the live webcast of bluebird bio’s
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02/24/21
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First pivotal study of BCMA-directed CAR T cell therapy in triple-class exposed relapsed and refractory multiple myeloma Biologics License Application (BLA) for ide-cel was accepted by FDA for Priority Review, with a target action date of March 27, 2021 CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb.
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02/23/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 23, 2021-- bluebird bio, Inc. (NASDAQ:BLUE) today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2020 and shared recent operational progress. “For over ten years, bluebird bio has been pioneering
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02/22/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 22, 2021-- bluebird bio, Inc. (NASDAQ: BLUE) today announced that members of the management team will participate in the 10 th Annual SVB Leerink Global Healthcare Conference , Thursday, February 25 , at 12:00 p.m. ET .
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02/16/21
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CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 16, 2021-- bluebird bio, Inc. (Nasdaq: BLUE) announced today that the company has placed its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease (SCD) (bb1111) on a temporary suspension due to a reported
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01/11/21
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Severe Genetic Disease business will remain the focus of bluebird bio, Inc.; separation expected to result in two independent, publicly traded companies by year-end 2021 Separation designed to unlock value through improved operational execution, organizational focus, tailored capital allocation,
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