BOSTON, MA / ACCESSWIRE / February 12, 2021 / Block & Leviton LLP (www.blockleviton.com), a national securities litigation firm, announces that a lawsuit for violation of the federal securities laws has been filed against bluebird bio, Inc. (NASDAQ:BLUE) and certain of its executives.
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.
A lawsuit has been filed against bluebird and certain of its executives in the U.S. District Court for the Eastern District of New York. The lawsuit is captioned Leung v. bluebird, Inc., et al., No. 21-cv-00777 (E.D.N.Y.). The suit alleges that bluebird misled investors as to the timing and likelihood of success of its plans to submit a BLA to the FDA for LentiGlobin by the second half of 2021.
If you purchased or acquired shares of bluebird between May 11, 2020 and November 4, 2020, you are strongly encouraged to contact the nationally-recognized securities law firm Block & Leviton LLP (www.blockleviton.com), at (617) 398-5600, via email at [email protected], or visit our website for information on the case. The deadline to move the Court to be appointed lead plaintiff is April 13, 2021.
Block & Leviton LLP is a firm dedicated to representing investors and maintaining the integrity of the country's financial markets. The firm represents many of the nation's largest institutional investors as well as individual investors in securities litigation throughout the United States. The firm's lawyers have recovered billions of dollars for its clients.
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SOURCE: Block & Leviton LLP