February 12, 2021 - An investor in shares of bluebird bio Inc (NASDAQ: BLUE) filed a lawsuit in the U.S. District Court for the Eastern District of New York over alleged violations of Federal Securities Laws by bluebird bio Inc in connection with certain allegedly false and misleading statements made between May 11, 2020 and November 4, 2020.
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, post-market, 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.
Shares of bluebird bio Inc (NASDAQ: BLUE) declined from $59.32 per share on November 4, 2020, to $42.19 per share on November 24, 2020.
According to the complaint the plaintiff alleges on behalf of purchasers of bluebird bio Inc (NASDAQ: BLUE) common shares between May 11, 2020 and November 4, 2020, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between May 11, 2020 and November 4, 2020, the Defendants made false and/or misleading statements and/or failed to disclose that data supporting bluebird's BLA submission for LentiGlobin for SCD was insufficient to demonstrate drug product comparability, that 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, that 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 that as a result, the Company's public statements were materially false and misleading at all relevant times.