bluebird bio, Inc. - BLUE STOCK NEWS

Bristol Myers Squibb (BMY) and bluebird bio (BLUE) revealed new findings from the pivotal KarMMa study on Abecma (idecabtagene vicleucel), a CAR T cell therapy for multiple myeloma. Updated results show a consistent overall response rate of 73% and a complete response in 33% of patients after a median follow-up of 24.8 months. The safety profile indicates common adverse events include cytopenias (97%) and cytokine release syndrome (84%). Abecma remains the first BCMA-directed CAR T therapy approved by the FDA, with ongoing reviews in other regions.

bluebird bio (Nasdaq: BLUE) will present significant data from its gene therapy programs for transfusion-dependent β-thalassemia and sickle cell disease, as well as its cell therapy for relapsed or refractory multiple myeloma during the EHA2021 Virtual Congress from June 9-17, 2021.

Key presentations include updates on betibeglogene autotemcel from the Phase 3 Northstar studies and the LentiGlobin study results for sickle cell disease. The company will also present long-term efficacy data for ABECMA in multiple myeloma, as part of its collaboration with Bristol Myers Squibb.

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 41^st 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.