BLUE - Bluebird bio stock halted for 2 days by Nasdaq ahead of FDA panel meet on gene therapies
Bluebird bio (NASDAQ:BLUE) said Nasdaq has halted trading of its common shares for June 9-10, ahead of a U.S. Food and Drug Administration (FDA) panel meeting to discuss applications seeking approval of its gene therapies. Earlier in the week, the company's shares gained after the FDA reviewers issued favorable remarks on the ?-thalassemia gene therapy betibeglogene autotemcel (beti-cel). The FDA, however, raised concerns over the other gene therapy candidate elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD) a rare, hereditary neurodegenerative X-linked metabolic disorder. The company had filed biologics licensing applications (BLAs) for beti-cel to treat people with ?-thalassemia who require regular red blood cell transfusions, and for eli-cel to treat early 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 donor. Bluebird said in a June 9 release that the BLAs for the two gene therapies will be discussed by the FDA's
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Bluebird bio stock halted for 2 days by Nasdaq ahead of FDA panel meet on gene therapies