bluebird bio, Inc. - BLUE STOCK NEWS

bluebird bio announced that the FDA has posted briefing documents for its advisory committee meeting regarding two gene therapies: elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy (CALD) and betibeglogene autotemcel (beti-cel) for β-thalassemia. The meeting is scheduled for June 9-10, 2022. The PDUFA goal dates for decisions on the therapies are August 19, 2022 and September 16, 2022, respectively. Past studies showed high efficacy rates for both therapies, but clinical trials face ongoing FDA scrutiny over potential adverse effects.

bluebird bio reported Q1 2022 financial results, ending with approximately $312 million in cash and equivalents. The company plans to reduce operating costs by 35-40% by year-end 2022 through restructuring, which includes a 30% workforce cut.

Key milestones include an FDA advisory committee meeting for beti-cel and eli-cel on June 9-10, 2022, and anticipated BLA submissions for lovo-cel in Q1 2023. Revenue rose to $1.9 million in Q1 2022 from $0.9 million in Q1 2021, while net loss increased marginally to $122.2 million.

bluebird bio (Nasdaq: BLUE) initiates a comprehensive restructuring aimed at achieving up to $160 million in cost savings over the next two years. The company anticipates a cash burn reduction to less than $340 million in 2022 and plans a 30% workforce reduction. This initiative is expected to extend bluebird's cash runway into the first half of 2023 while maintaining focus on FDA approvals for gene therapies for beta-thalassemia and cerebral adrenoleukodystrophy. Key PDUFA dates are set for August 19 and September 16, 2022.

bluebird bio reported its financial results for Q4 and the full year 2021, highlighting key milestones in gene therapy development. The company has two therapies under FDA review: beti-cel for beta-thalassemia and eli-cel for cerebral adrenoleukodystrophy, with lovo-cel's BLA submission for sickle cell disease on track for Q1 2023. As of December 31, 2021, bluebird bio held approximately $442M in cash and equivalents. However, the company anticipates operating losses and is exploring financing options amid doubts about its ability to continue as a going concern within the next year.

bluebird bio (NASDAQ: BLUE) announced an extension of the FDA review periods for its gene therapies, betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel). The new PDUFA goal dates are August 19, 2022 and September 16, 2022, respectively, allowing the FDA to review additional clinical data submitted by bluebird. Notably, this extension does not relate to new safety issues. If approved, these therapies will be the first of their kind in the U.S. for severe genetic diseases. The company also addressed a partial clinical hold on another therapy, lovotibeglogene autotemcel (lovo-cel).

bluebird bio, Inc. (Nasdaq: BLUE) has announced key updates for the 40th Annual J.P. Morgan Healthcare Conference, focusing on its gene therapy programs. The company anticipates FDA reviews for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel) in 2022, with potential launches in mid-2022. The company aims to complete validation lots for its third therapy, lovotibeglogene autotemcel (lovo-cel), amid ongoing clinical holds. bluebird bio projects a cash balance of approximately $442 million, expecting a cash burn of less than $400 million in 2022 and potential cash inflows of $150-200 million from priority review vouchers.

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.