bluebird bio, Inc. - BLUE STOCK NEWS

bluebird bio, Inc. (NASDAQ: BLUE) will report its Q2 2021 financial results on August 9, 2021, followed by a conference call at 8 a.m. ET. Investors can access the call by dialing (844) 825-4408 or +1 (315) 625-3227 for international calls. The company will also participate in the Wedbush PacGrow Healthcare Conference on August 11 at 12:00 p.m. ET. bluebird bio focuses on gene therapies for severe genetic diseases and cancer, aiming to provide treatment options for patients with critical needs.

bluebird bio, Inc. (NASDAQ: BLUE) has approved inducement grants for a newly hired employee, consisting of stock options for 85,000 shares and 50,000 restricted stock units (RSUs), effective August 2, 2021. The stock options have an exercise price of $25.60, vesting over four years, with 25% vesting on the first anniversary and 1/36 monthly thereafter. The RSUs similarly vest over four years with 25% at the end of the first year. This action complies with NASDAQ Listing Rule 5635(c)(4) and reflects the company's commitment to attract talent in gene therapy development.

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.