bluebird bio, Inc.
Lead Plaintiff Deadline: 04/13/2021
SUMMARY OF CASE:
A securities class action has been filed against bluebird bio, Inc. (BLUE) on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired bluebird securities between May 11, 2020 through November 4, 2020. This case has been filed in the USDC – E.D.N.Y.
The Complaint alleges that 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.
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.
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.
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.