bluebird bio, Inc. (BLUE)
Bronstein, Gewirtz & Grossman, LLC a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against bluebird bio, Inc. (“Blue” or “the Company”) (NASDAQ: BLUE) and certain of its officers.
Class Definition:
This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired Blue securities between April 24, 2023 and December 8, 2023, inclusive (the “Class Period”). Such investors are encouraged to join this case.
Case Details:
According to the Complaint, Blue is a biotechnology company that researches, develops, and commercializes gene therapies for severe genetic diseases. On April 24, 2023, Blue 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 (VOEs). 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.
The Complaint alleges that throughout the Class Period the Company made materially false and/or misleading statements. Specifically, Blue created the false impression that:
(1) it could obtain FDA approval for lovo-cel without any black box warnings for haematological malignancies;
(2) it 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;
(3) as a result, the Company had significantly overstated Lyfgenia’s clinical and/or commercial prospects; and
(4) therefore, the Company’s public statements were materially false and misleading at all relevant times.
On December 8, 2023, according to the Complaint, Blue issued a press release announcing that it received approval from the FDA for its ex-vivo gene therapy drug Lyfgenia for sickle cell disease. However, the FDA approval also came with a black box warning for haematological malignancies and requirement to monitor patients for cancer through complete blood counts at least every six months for at least 15 years. Further, the Company’s anticipated priority review voucher was denied by the FDA.
On this news, the price of Blue’s common stock declined, according to the Complaint, from a closing market price of $4.81 per share on December 7, 2023, to $2.86 per share on December 8, 2023.
What’s Next?
A class action lawsuit has already been filed. You may review a copy of the Complaint. You may also contact Peretz Bronstein, Esq. or his Law Clerk and Client Relations Manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660. If you suffered a loss in Blue you have until May 28, 2024, to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff.
There is No Cost to You
We represent investors in class actions on a contingency fee basis. That means we will ask the court to reimburse us for out-of-pocket expenses and attorneys’ fees, usually a percentage of the total recovery, only if we are successful.
Why Bronstein, Gewirtz & Grossman:
Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits. Our firm has recovered hundreds of millions of dollars for investors nationwide.
Attorney advertising. Prior results do not guarantee similar outcomes.
Contact:
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Yael Nathanson