BLUE - Bluebird bio poised for another regulatory win - Morgan Stanley

Bluebird bio (NASDAQ:BLUE) is set to win the backing of a key FDA committee for a gene therapy candidate for ?-thalassemia after the biotech received its strong support for a similar drug targeting a rare neurodegenerative on Thursday, Morgan Stanley argues. The company shares remain on hold for trading as the members of the FDA Cellular, Tissue, and Gene Therapies Advisory Committee review the data for beti-cel in transfusion-dependent ?-thalassemia (TDT) ahead of a decision on its suitability for approval on Friday. The FDA AdCom committees issue non-binding recommendations. However, the agency usually follows them before making a final decision. Commenting on the AdCom backing for Bluebird’s (BLUE) other gene therapy, eli-cel in children with rare neurodegenerative disease cerebral adrenoleukodystrophy (CALD), Morgan Stanley analysts led by Matthew Harrison expects a positive vote for beti-cel as well. “Considering that FDA has recognized the efficacy benefit of beti-cel in the briefing document, today's

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Bluebird bio poised for another regulatory win – Morgan Stanley