LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired bluebird bio, Inc. (“bluebird” or the “Company”) (NASDAQ: BLUE) securities between May 11, 2020 and November 4, 2020, inclusive (the “Class Period”). Bluebird investors have until April 13, 2021 to file a lead plaintiff motion.
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In May 2020, in the midst of the COVID-19 pandemic, bluebird announced that the Company expected to submit a U.S. Biologics Licensing Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for LentiGlobin for sickle cell disease in the second half of 2021.
On November 4, 2020, post-market, bluebird disclosed that it would delay its BLA submission to late 2022 due to “feedback” from the FDA that requires the Company to provide additional data “to demonstrate drug product comparability” for LentiGlobin for sickle cell disease, as well as “COVID-19 related shifts and contract manufacturing organization COVID-19 impacts.”
On this news, bluebird’s stock price fell $9.72 per share, or 16.6%, to close at $48.83 per share on November 5, 2020.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) data supporting bluebird's BLA submission for LentiGlobin for SCD was insufficient to demonstrate drug product comparability; (2) Defendants downplayed the foreseeable impact of disruptions related to the COVID-19 pandemic on the Company's BLA submission schedule for LentiGlobin for SCD, particularly with respect to manufacturing; (3) as a result of all the foregoing, it was foreseeable that the Company would not submit the BLA for LentiGlobin for SCD in the second half of 2021; and (4) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
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If you purchased bluebird securities during the Class Period, you may move the Court no later than April 13, 2021 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased bluebird securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to email@example.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
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