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Bluebird Bio Inc (BLUE) delivers pioneering gene therapies for severe genetic disorders through its advanced lentiviral vector platform. This news hub provides investors and healthcare stakeholders with timely updates on clinical developments, regulatory milestones, and strategic partnerships shaping the future of genomic medicine.
Access authoritative coverage of BLUE's material events including trial results, FDA interactions, and commercialization progress. Our curated news collection features earnings reports, research breakthroughs, and executive commentary – all essential for understanding this innovative biotech's trajectory.
Key updates across critical categories: clinical trial phases, therapy approvals, intellectual property developments, and financial performance. Monitor BLUE's progress in cancer immunotherapy and gene editing initiatives through verified press releases and objective analysis.
Bookmark this page for streamlined tracking of Bluebird Bio's advancements in transformative genetic medicines. Check regularly for updates that could impact both patient care and investment considerations in the evolving biotechnology sector.
bluebird bio reported Q1 2021 financial results, showing revenues of $12.8 million, down from $21.9 million in Q1 2020, primarily due to lower ide-cel revenue. R&D expenses rose slightly to $154.5 million, while SG&A expenses increased to $86.9 million, attributed to higher compensation and consulting fees. The net loss widened to $205.8 million. Highlights include FDA approval for Abecma, the first CAR T therapy for multiple myeloma, and the planned separation into two companies by year-end 2021. The cash position decreased to $1.09 billion.
bluebird bio, Inc. (NASDAQ: BLUE) announced upcoming participation in two investor conferences: the BofA Securities 2021 Health Care Conference on May 13 at 9:30 am ET and the 2021 RBC Capital Markets Global Healthcare Conference on May 19 at 1:55 pm ET. Interested investors can access live webcasts through the company's website, with replays available for 90 days post-event.
The company focuses on gene therapy for severe genetic diseases and cancer, aiming to provide treatment options for those facing life-threatening conditions.
bluebird bio (Nasdaq: BLUE) has provided significant updates regarding its gene therapy programs addressing severe genetic diseases. The company corrected a previous diagnosis of MDS in a patient, moving it to transfusion-dependent anemia, aiding its regulatory efforts to lift clinical holds on studies HGB-206 and HGB-210 for LentiGlobin. Following unsuccessful reimbursement negotiations for ZYNTEGLO in Germany, bluebird is restructuring its workforce to align with strategic priorities. The company remains optimistic about advancing its gene therapies in Europe while addressing ongoing safety evaluations.
bluebird bio announced new data on its gene therapy, eli-cel, for treating cerebral adrenoleukodystrophy (CALD) at the EBMT 2021 symposium. In the pivotal Phase 2/3 Starbeam study, 90% of patients showed no major functional disabilities at 24 months follow-up. This treatment offers a one-time solution, avoiding risks associated with stem cell transplants. Notably, long-term data indicated stability in neurologic function without graft-versus-host disease. The company aims to submit its Biologics License Application by mid-2021, reinforcing its commitment to innovative treatments.
bluebird bio (Nasdaq: BLUE) reported that the recent case of acute myeloid leukemia (AML) in its Phase 1/2 HGB-206 study of LentiGlobin for sickle cell disease is unlikely linked to the BB305 lentiviral vector. Analysis uncovered genetic mutations typical of AML, while vector insertion occurred at a site (VAMP4) not associated with AML risks. Regulatory discussions with the FDA are ongoing to lift clinical holds on relevant studies. The company also reported a separate SUSAR of myelodysplastic syndrome (MDS) under investigation but found no malignancy linked to ZYNTEGLO’s use.
bluebird bio (NASDAQ: BLUE) will participate in the Cowen 41st Annual Health Care Conference on March 3, at 2:40 p.m. ET. A live webcast of the presentation can be accessed via the Investors & Media section of their website. The replay will be available for 90 days post-event. bluebird bio focuses on developing gene therapies for severe genetic diseases and cancer, aiming to provide treatment options for life-threatening conditions. The company operates from multiple locations, including Cambridge, MA, and Zug, Switzerland.
bluebird bio, Inc. (Nasdaq: BLUE) and Bristol Myers Squibb's investigational CAR T therapy, idecabtagene vicleucel (ide-cel), has shown promising results in a pivotal Phase 2 KarMMa study for relapsed and refractory multiple myeloma. The study, published in The New England Journal of Medicine, met its primary endpoint for overall response rate and secondary endpoint for complete response rate. Of the 128 patients treated, meaningful responses were observed in high-risk subgroups. The therapy's safety profile was consistent with CAR T treatments, with cytopenia and cytokine release syndrome being the most common adverse events.
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.
