Bluebird Bio Inc Stock Price, News & Analysis

bluebird bio (Nasdaq: BLUE) announced participation in the 40th Annual J.P. Morgan Healthcare Conference on January 12 at 3:45 p.m. ET. Interested parties can access the live webcast on the company's website's 'Events & Presentations' page, with a replay available for 30 days afterwards. bluebird bio focuses on curative gene therapies for severe genetic diseases like sickle cell disease and β-thalassemia, supported by extensive clinical data since its founding in 2010.

bluebird bio (NASDAQ: BLUE) announced the FDA has placed its clinical program for lovo-cel gene therapy for sickle cell disease on partial hold for patients under 18. This action follows an investigation into a patient experiencing persistent anemia post-treatment, though no malignancy has been found. Adult patient enrollment continues in ongoing studies. The company plans to respond to the FDA's inquiries and evaluates the potential impact on its biologics license application submission timeline.

bluebird bio announced that the FDA has accepted the Biologics License Application (BLA) for its gene therapy, eli-cel, aimed at treating cerebral adrenoleukodystrophy (CALD) in children. If approved by the PDUFA date of June 17, 2022, eli-cel will be the first gene therapy for CALD, a rare neurodegenerative disease. The therapy has shown promising efficacy, with 90.6% of patients achieving primary endpoints in clinical trials. However, the clinical program is currently on hold due to reports of myelodysplastic syndrome linked to the treatment. The FDA granted eli-cel several designations, highlighting its potential in addressing serious medical needs.

bluebird bio has released updated results from its Phase 1/2 HGB-206 study of lovo-cel, a gene therapy for sickle cell disease, highlighting improved biologic and clinical outcomes. The data show stable production of anti-sickling hemoglobin and resolution of severe vaso-occlusive events (VOEs) for up to 36 months. Patient-reported outcomes indicate significant enhancements in health-related quality of life. With a median follow-up of 17.3 months, 35 patients achieved near-normal hemoglobin levels, with no severe VOEs reported in the Group C cohort.

bluebird bio (Nasdaq: BLUE) presented new long-term data on betibeglogene autotemcel (beti-cel) at the ASH Annual Meeting. The results show that patients with β-thalassemia achieved transfusion independence for up to seven years, with 89% of phase 3 patients experiencing normal hemoglobin levels. The therapy potentially eliminates the need for regular transfusions and stabilizes iron markers, with 59% of patients able to stop iron chelation. The FDA is currently reviewing a biologics license application for beti-cel, with a decision expected by May 20, 2022.

bluebird bio (Nasdaq: BLUE) announced that the FDA has accepted its Biologics License Application for betibeglogene autotemcel (beti-cel) for priority review. If approved, beti-cel will be the first one-time treatment targeting the genetic cause of β-thalassemia, benefiting patients dependent on regular red blood cell transfusions. The PDUFA goal date is May 20, 2022. The application is based on extensive clinical data, demonstrating potential for transfusion independence in 89% of patients.

AavantiBio has appointed Dr. Jenny Marlowe as Chief Scientific Officer. She brings nearly 15 years of experience in the biopharmaceutical sector, previously serving at Bluebird Bio (NASDAQ: BLUE) as VP of Preclinical & Translational Development. Dr. Marlowe will lead scientific research and preclinical development at AavantiBio, which focuses on gene therapies for rare diseases. The company has secured over $107 million in Series A financing and is advancing its gene therapy pipeline, including partnerships with leading organizations such as the University of Florida.

bluebird bio reported Q3 2021 results, revealing total revenues of $22.7 million, up from $19.3 million in Q3 2020, driven by collaborative arrangements. However, total revenues for the nine months declined to $42.9 million from $240.0 million, influenced by a revenue adjustment related to a previous contract modification. The company completed its separation from 2seventy bio and has a strong cash position of approximately $518.5 million. A net loss of $216.8 million was reported for Q3, reflecting ongoing financial challenges and restructuring costs.

bluebird bio (NASDAQ: BLUE) has signed a long-term lease for a new headquarters in Somerville, Massachusetts, expanding into a 61,000 square foot biotech hub at Assembly Row. This move involves relocating approximately 425 employees in spring 2022 and is anticipated to yield over $120 million in cost savings over six years. The new facility supports a hybrid work model and provides employees with modern amenities. The company will keep its laboratory at 60 Binney St., Cambridge, until the end of 2023, as it focuses on gene therapies for severe genetic diseases.