Filing delay causes bluebird bio shares to suffer again

5 November 2020

US biotech bluebird bio (Nasdaq: BLUE) looked set to open Thursday’s trading almost 14% lower after announcing an update on its US filing of LentiGlobin for sickle cell disease (bb1111).

The company confirmed its general agreement with the US Food and Drug Administration (FDA) that the clinical data package required to support the Biologics License Application (BLA) will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated.

A path to transition to commercial manufacturing using an analytical comparability strategy, including suspension-based lentiviral vector, has also been agreed with the FDA.

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