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FDA Places New CMC Demands on bluebird’s Sickle Cell Treatment

November 5, 2020

Via: BioSpace

Shares of bluebird bio fell more than 17% in premarket trading after the company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration (FDA) for two more years.

During its quarterly report announcement on Wednesday, Cambridge, Mass.-based bluebird bio said the FDA has agreed to base its review of bb1111, a LentiGlobin treatment for sickle cell disease, on promising data from Group C of the HGB-206 study. bluebird bio said it reached a general agreement with the FDA on its path to transition to commercial manufacturing using an analytical comparability strategy, including suspension-based lentiviral vector (sLVV).

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