One of bluebird’s gene therapy programs is called LentiGlobin, and is in design to treat sickle cell disease. On May 11, 2020, bluebird announced that the Company expected to submit a U.S. Biologics Licensing Application (“BLA”) to the U.S. Food and Drug Administration for its product, LentiGlobin, in the second half of 2021. In making this announcement, bluebird stated that it had “general agreement with [the] FDA” as to the requirements of the clinical data package required to support the BLA,” and that “all operational plans . . . reflect COVID-19 uncertainties and recent program shifts.”
However, on November 4, 2020, bluebird disclosed that it would no longer file the BLA for LentiGlobin in the second half of 2021 as expected. Instead, citing “feedback” from the FDA requiring the Company to provide additional data, along with “COVID-19 related shifts and contract manufacturing organization COVID-19 impacts,” bluebird said it would not submit the BLA until late 2022. The market was stunned by this development, and shares fell by nearly 17% to close at just $48.83 on November 5, 2020.