NEW YORK, March 28, 2024 (GLOBE NEWSWIRE) — Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Bluebird bio Inc. (“Blue” or the “Company”) (NASDAQ: BLUE) in the United States District Court for the District of Massachusetts on behalf of all persons and entities who purchased or otherwise acquired Blue securities between April 24, 2023 and December 8, 2023, both dates inclusive (the “Class Period”). Investors have until May 27, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Blue is a biotechnology company that researches, develops, and commercializes gene therapies for severe genetic diseases. Its product candidates for severe genetic diseases include ZYNTEGLO (betibeglogene autotemcel) for the treatment of transfusion-dependent ßthalassemia; LYFGENIA (lovotibeglogene autotemcel) for the treatment of sickle cell disease (SCD); and SKYSONA (elivaldogene autotemcel) to treat cerebral adrenoleukodystrophy.
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 (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.
According to the complaint, the Company’s announcement provided investors with false and misleading information in order to bolster investor expectations and share prices. Specifically, Defendants created the false impression that: (i) they could obtain FDA approval for lovo-cel without any box warnings for haematological malignancies; (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 lovocel launch; (iii) as a result, the Company had significantly overstated Lyfgenia’s clinical and/or commercial prospects; and (iv) therefore, the Company’s public statements were materially false and misleading at all relevant times. This caused Plaintiff and other shareholders to purchase Blue’s securities at artificially inflated prices.
On December 8, 2023, 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. 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 Blue’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.
If you purchased or otherwise acquired Blue shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact Information:
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
