Bluebird Bio Inc Stock Price, News & Analysis

bluebird bio, Inc. (NASDAQ: BLUE) announced a strategic alliance with National Resilience, Inc. to enhance cell therapy manufacturing. Resilience will acquire bluebird’s Research Triangle facility for $110 million, retaining over 100 employees and ensuring ongoing supply of lentiviral vector (LVV) for their therapies. This partnership allows for shared expenses and revenue for oncology products, while expanding manufacturing capabilities. The deal is subject to regulatory approvals and aims to bolster innovation in gene therapy development.

bluebird bio (Nasdaq: BLUE) received marketing authorization from the European Commission for SKYSONA™ (elivaldogene autotemcel), the first gene therapy approved in the EU for treating early cerebral adrenoleukodystrophy (CALD) in patients under 18 without a matched sibling donor. This therapy targets the ABCD1 genetic mutation, critical for halting the progression of a disease that can lead to severe neurological decline. The approval covers all 27 EU member states and follows a rigorous clinical development program demonstrating significant efficacy.

bluebird bio (Nasdaq: BLUE) announced that the EMA's Pharmacovigilance Risk Assessment Committee has deemed the benefit-risk balance of ZYNTEGLO™ favorable, lifting the voluntary marketing suspension. The company emphasizes patient safety and expresses gratitude for the PRAC's review, enabling ZYNTEGLO to be offered again to those with transfusion-dependent β-thalassemia. No hematologic malignancies have been reported in treated patients. FDA has also lifted clinical holds on related studies. The company aims to submit a BLA for ZYNTEGLO by mid-2021.

bluebird bio (Nasdaq: BLUE) presented promising long-term data on its gene therapy, betibeglogene autotemcel (beti-cel), for treating transfusion-dependent β-thalassemia (TDT) at EHA2021. The therapy has shown successful transfusion independence in 89% of evaluable patients across Phase 3 studies, with a median ongoing transfusion-free duration of 25 months. Patients experienced normal to near-normal hemoglobin levels and significant reductions in liver iron concentration. No serious drug-related adverse events were reported, highlighting beti-cel's potential as a transformative treatment for TDT.

bluebird bio, Inc. (NASDAQ: BLUE) will participate in the Goldman Sachs 42^nd Annual Global Healthcare Conference on June 8 at 8:50 a.m. ET. The live webcast of the presentation can be accessed on their Investors & Media page. A replay will be available for 90 days post-event. bluebird bio is focused on developing gene therapies for severe genetic diseases and cancer, aiming to improve access and education in healthcare. The company operates from multiple locations, including Cambridge, Mass., Seattle, Durham, and Zug.

bluebird bio (Nasdaq: BLUE) announced the FDA has lifted clinical holds on several studies, including LentiGlobin for sickle cell disease and betibeglogene autotemcel for β-thalassemia. This decision allows the resumption of clinical trial activities for both gene therapies, which are significant advancements in treating these inherited conditions. The company emphasizes its commitment to patient safety and adheres to regulatory standards, while preparing for major submissions in the near future. Notably, LentiGlobin remains investigational and has not yet received approval in any region.

bluebird bio, Inc. (Nasdaq: BLUE) has announced the approval of inducement grants for stock options and restricted stock units (RSUs) totaling 50,000 shares and 25,000 RSUs to Chief Commercial Officer Tom Klima. The stock options have an exercise price of $31.11 and will vest over four years. The RSUs will also vest over four years, starting with 25% on the first anniversary of the grant date. This move complies with NASDAQ Listing Rule 5635(c)(4) as part of Mr. Klima's employment agreement.

bluebird bio (Nasdaq: BLUE) announced a positive opinion from the CHMP of the EMA recommending marketing authorization for SKYSONA™ (elivaldogene autotemcel, Lenti-D™). This one-time gene therapy targets early cerebral adrenoleukodystrophy (CALD) in children under 18 who lack a matched sibling donor. If approved by the European Commission, SKYSONA would be the first gene therapy for CALD, offering hope to patients with this severe condition. The final decision is expected in mid-2021.

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.