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Bluebird Bio Stock Trading Halted Today And Tomorrow By Nasdaq

bluebird bio, Inc. (BLUE) announced Thursday that the Nasdaq has halted trading of the company's common stock on Thursday, June 9 and Friday, June 10, 2022.

The U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) is meeting to discuss the biologics licensing applications (BLAs) for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel).

Beti-cel is under review for the treatment of people with ß-thalassemia who require regular red blood cell transfusions.

Meanwhile, eli-cel is under review for the treatment of early active cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age who do not have an available and willing human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell (HSC) donor.

The Prescription Drug User Fee Act (PDUFA) goal dates for a decision on approval of beti-cel for people with beta-thalassemia who require regular red blood cell transfusions and eli-cel for patients with early active CALD without a matched sibling donor are August 19, 2022, and September 16, 2022, respectively.

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