Robbins LLP is Investigating the Allegations that bluebird bio, Inc. (BLUE) Overstated the Clinical and/or Commercial Prospects of its Drug

Robbins LLP informs investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired bluebird bio, Inc. (NASDAQ: BLUE) common stock between April 24, 2023 and December 8, 2023. Bluebird is a biotechnology company that researches, develops, and commercializes gene therapies for severe genetic diseases.

The Allegations

According to the complaint, on April 24, 2023, defendants announced submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events. The BLA also included a request for priority review, which, if granted, would shorten the FDA’s review of the application to six months from the time of filing, versus a standard review timeline of 10 months.

On December 8, 2023, Bluebird issued a press release announcing that it received approval from the FDA for its ex-vivo gene therapy drug Lyfgenia for sickle cell disease. Along with the approval came a black box warning for haematological malignancies with a requirement to monitor patients for cancer through complete blood counts at least every six months for at least 15 years, plus viral vector integration site analysis at month 6, 12 and as warranted. Further, the Company’s anticipated priority review voucher was denied by the FDA. On this news, the price of Bluebird’s common stock declined from a closing market price of $4.81 per share on December 7, 2023, to $2.86 per share on December 8, 2023.

Plaintiffs allege that defendants created the false impression that (i) they could obtain FDA approval for lovo-cel without any box warnings for haematological malignancies, and (ii) they would be granted a priority review voucher by the FDA and in turn sell it in order to strengthen their financial position for the lovo-cel launch. As a result, the Company had significantly overstated Lyfgenia’s clinical and/or commercial prospects.

What Now: You may be eligible to participate in the class action against bluebird bio, Inc. Shareholders who want to serve as lead plaintiff for the class must file their papers with the court by May 28, 2024. A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.