SAN DIEGO, March 30, 2024 (GLOBE NEWSWIRE) — Robbins LLP informs investors that a shareholder has filed a class action on behalf of all persons and entities who purchased or otherwise acquired common stock of bluebird bio, Inc. (NASDAQ : BLUE) between April 24, 2023 and December 8, 2023. Bluebird is a biotechnology company that researches, develops and commercializes gene therapies for serious genetic diseases.
For more information, submit a form, email Attorney Aaron Dumas, Jr., or call us at (800) 350-6003.
The accusations: Robbins LLP is investigating allegations that bluebird bio, Inc. (BLUE) overstated the clinical and/or commercial prospects of its drug
According to the complaint, on April 24, 2023, the defendants announced the submission of a 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) ) aged 12 years or older who have a history of vaso-occlusive events (VOE). 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 submission, compared to a standard review timeline of 10 months.
On December 8, 2023, Bluebird issued a press release announcing that it had received FDA approval for its ex vivo gene therapy drug Lyfgenia for sickle cell disease. Along with the approval came a black box warning for hematologic malignancies with a requirement to monitor patients for cancer through complete blood counts at least every six months for at least 15 years, as well as analysis of the site of viral vector integration at month 6, 12 and as guaranteed. Additionally, the Company’s expected priority review voucher was denied by the FDA. On this news, the price of Bluebird’s common stock fell 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 warning for hematologic malignancies; (ii) they would receive a priority review voucher from the FDA and sell it themselves to strengthen their financial position for the launch of lovo-cel; and (iii) as a result, the Company significantly overestimated the clinical and/or commercial prospects of Lyfgenia.
And now: You may be entitled to participate in the class action against bluebird bio, Inc. Shareholders who wish to serve as lead plaintiff for the class must file their paperwork with the court by May 28, 2024. A lead plaintiff is a representative party acting on behalf of other class members in handling 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 may remain an absent class member. For more information, click Here.
All representation is based on contingency fees. Shareholders pay no commissions or expenses.
About Robbins LLP: Some law firms that issue press releases on this topic do not actually pursue securities class actions; Robbins LLP does. A recognized leader in shareholder rights litigation, the attorneys and staff at Robbins LLP have been committed to helping shareholders recover losses, improve corporate governance structures and hold company executives accountable for their wrongdoings since 2002. In the beginning, we raised over $1 billion for shareholders.
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