bluebird bio, Inc. - BLUE STOCK NEWS

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.

bluebird bio (Nasdaq: BLUE) announced new findings for its gene therapies, betibeglogene autotemcel (beti-cel) and LentiGlobin, to be presented at the American Society of Hematology (ASH) Annual Meeting from December 11-14, 2021. The results indicate long-term efficacy, including sustained iron level stabilization in beta-thalassemia patients and improved quality of life in sickle cell disease patients. A biologics license application for beti-cel has been submitted to the FDA, reinforcing BLUE's commitment to innovative gene therapies.

bluebird bio completed the tax-free spin-off of its oncology programs into 2seventy bio, focusing on gene therapies for severe genetic diseases. The company has three near-term programs targeting sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. It plans to host a spotlight investor call on November 18, 2021, regarding its bb1111 candidate for sickle cell disease. bluebird bio has submitted a biologics licensing application for betibeglogene autotemcel and anticipates a BLA for elivaldogene autotemcel by the end of 2021.

bluebird bio, Inc. (NASDAQ: BLUE) announced that October 19, 2021, will be the record date for the dividend distribution of 2seventy bio, Inc. shares to bluebird stockholders, marking the separation of the two companies. Each stockholder will receive one share of 2seventy for every three shares of bluebird held. The distribution will occur on or about November 4, 2021. The SEC has declared 2seventy’s Registration Statement effective, detailing the tax-free spin-off of bluebird's oncology programs. Expected trading for 2seventy will begin on October 18, 2021, under the symbol 'TSVT'.

bluebird bio has announced a tax-free spin-off of its oncology programs into 2seventy bio, with a completion timeline of early November 2021. Shareholders will receive 1 share of 2seventy bio for every 3 shares of bluebird bio owned. The company expects approximately $1.0B in cash reserves at the time of separation, funding 2seventy bio with $480M. Two new board members, Najoh Tita-Reid and Sarah Glickman, have been appointed to strengthen leadership. The separation is designed to enhance operational focus and shareholder value.