Bluebird Bio Inc Stock Price, News & Analysis

bluebird bio reported its financial results for Q4 and full year 2020, noting a significant revenue increase from $44.7 million in 2019 to $250.7 million in 2020. Despite a net loss reduction to $618.7 million from $789.6 million, the company faces challenges, including a clinical hold on LentiGlobin studies due to safety events. Upcoming milestones include the PDUFA action date for ide-cel on March 27, 2021, and potential EU approval for eli-cel mid-year. The company is separating its severe genetic disease and oncology ventures by the end of 2021.

bluebird bio (NASDAQ: BLUE) will participate in the 10th Annual SVB Leerink Global Healthcare Conference on February 25 at 12:00 p.m. ET. A live webcast of the event can be accessed on the company’s website, with a replay available for 90 days post-event. bluebird bio specializes in developing gene therapies for severe genetic diseases and cancer, aiming to provide treatments for conditions with limited options. The company operates from multiple locations including Cambridge, Seattle, Durham, and Zug.

bluebird bio (Nasdaq: BLUE) announced a temporary suspension of its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies for LentiGlobin gene therapy for sickle cell disease due to a reported serious adverse reaction—a case of acute myeloid leukemia (AML) in a patient treated over five years ago. This investigation is critical in assessing the safety of their therapies, including ZYNTEGLO, which is manufactured utilizing the same BB305 lentiviral vector. The company is actively working with regulatory bodies and has notified their independent safety review board.

bluebird bio (Nasdaq: BLUE) plans to separate its severe genetic disease and oncology businesses into independent companies, maintaining a focus on severe genetic diseases. This tax-free spin-off, called Oncology Newco, is expected to enhance operational efficiency and attract suitable investors. Post-separation, current CEO Nick Leschly will lead Oncology Newco, while Andrew Obenshain will continue as CEO for bluebird bio. The separation aims to optimize innovation and financial performance for both entities, with an anticipated completion by Q4 2021.

bluebird bio (Nasdaq: BLUE) announced promising new data from Group C of its Phase 1/2 HGB-206 study of LentiGlobin gene therapy for sickle cell disease (SCD). Results show a complete elimination of severe vaso-occlusive events (VOEs) between six and 24 months, with sustained levels of the anti-sickling hemoglobin HbA in treated patients. Key findings presented at the American Society of Hematology (ASH) Annual Meeting include improved health-related quality of life and a significant reduction in patient-reported pain, underscoring LentiGlobin's potential as a disease-modifying treatment.

bluebird bio (Nasdaq: BLUE) presented long-term efficacy and safety results for betibeglogene autotemcel gene therapy (beti-cel) for transfusion-dependent β-thalassemia at the 62nd ASH Annual Meeting. Data revealed that 87% of pediatric patients and 64%-90% of adults achieved transfusion independence, with median post-infusion follow-up of 49.1 months. The European Commission granted conditional marketing authorization for beti-cel, while it remains under evaluation in the U.S. No serious adverse events were linked to the therapy beyond two years.

bluebird bio (Nasdaq: BLUE) will host a live webcast on December 7, 2020, at 7:00 p.m. ET to discuss clinical data from the 62nd American Society of Hematology Annual Meeting. Investors can join by calling (844) 825-4408 in the U.S. or +1 (315) 625-3227 internationally, using conference ID 3493595. The webcast will be accessible through the Investors & Media section of the company's website and will be available for 90 days after the event. bluebird bio focuses on gene therapies for severe genetic diseases and cancer.

bluebird bio (Nasdaq: BLUE) announced that data from its gene and cell therapy programs for sickle cell disease (SCD), transfusion-dependent beta-thalassemia (TDT), and multiple myeloma (MM) will be presented at the 62nd ASH Annual Meeting, held virtually from December 5-8, 2020. Key presentations include updated results from the Phase 1/2 HGB-206 study of LentiGlobin™ for SCD and data from multiple studies on betibeglogene autotemcel for TDT and anti-BCMA CAR T cell therapies for MM. These studies highlight improvements in health-related quality of life and long-term efficacy for treatment options.

bluebird bio (Nasdaq: BLUE) announced that the European Medicines Agency (EMA) has accepted its marketing authorization application (MAA) for its investigational gene therapy, elivaldogene autotemcel (eli-cel), aimed at treating cerebral adrenoleukodystrophy (CALD), a severe neurodegenerative disorder. This therapy could be the first to use patients' own stem cells, potentially reducing immune risks. The MAA is based on data from clinical studies, including the Phase 2/3 Starbeam study. The FDA has granted eli-cel several designations, and bluebird bio aims to submit a Biologics License Application in mid-2021.