Investigation of Bluebird Bio, Inc.
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Bluebird Bio, Inc. (BLUE) Misled Shareholders About the Viability of LentiGlobin
According to the complaint, in May 2020, bluebird announced it expected to submit a U.S. Biologistcs Licensing Application to the U.S. Food and Drug Administration (FDA) for LentiGlobin for SCD in the second half of 2021. However, the data supporting bluebird’s submission was insufficient to demonstrate drug product comparability and the Company downplayed the impact of disruptions related to the COVID-19 pandemic on its submission schedule, particularly with respect to manufacturing.
On November 4, 2020, bluebird disclosed that it would no longer apply for FDA approval of its LentiGlobin product as a treatment for SCD in the second half of 2021 as expected. Citing feedback from the FDA requiring the Company to provide additional data “to demonstrate drug product comparability” for LentiGlobin for SCD, “alongside COVID-19 related shifts and contract manufacturing organizations COVID-19 impacts,” bluebird adjusted its submission timing to late 2022. On this news, bluebird’s stock fell $9.72 per share, or over 16%, to close at $48.83 per share on November 5, 2020.