Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, Reminds Investors that a class action lawsuit has been filed in the United States District Court for the District of Massachusetts on behalf of investors that purchased bluebird bio, Inc. (NASDAQ: BLUE) securities between May 11, 2020 and November 4, 2020, inclusive (the “Class Period”). Investors have until April 13, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Bluebird is a biotechnology company that engages in researching, developing, and commercializing transformative gene therapies for severe genetic diseases and cancer. The Company’s gene therapy programs include, among others, LentiGlobin (bb1111) for the treatment of sickle cell disease (“SCD”).
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 SCD in the second half of 2021.
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. Instead, 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 organization COVID-19 impacts,” bluebird adjusted its submission timing to late 2022.
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 on February 12, 2021, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) data supporting bluebird’s BLA submission for LentiGlobin for SCD was insufficient to demonstrate drug product comparability; (ii) 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; (iii) 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 (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
If you purchased bluebird securities during the Class Period and suffered a loss, are a long-term stockholder, have information, 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 Brandon Walker, Melissa Fortunato, or Marion Passmore by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.