NEW YORK, May 01, 2024 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against bluebird bio, Inc. (“Blue” or the “Company”) (NASDAQ: BLUE) and reminds investors of the May 28, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $100,000 In Blue To Contact Him Directly To Discuss Their Options

If you suffered losses exceeding $100,000 investing in Blue stock or options between April 24, 2023 and December 8, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/BLUE.

Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See www.faruqilaw.com.

The bluebird bio class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) they could obtain FDA approval for lovo-cel without any box warnings for haematological malignancies; (2) 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; (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.

The bluebird bio class action lawsuit further alleges that on December 8, 2023, bluebird bio disclosed that: (i) it received approval from the FDA for its ex-vivo gene therapy drug Lyfgenia for sickle cell disease; (ii) 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 6 months for at least 15 years, plus viral vector integration site analysis at month 6, 12, and as warranted; and (iii) bluebird bio's anticipated priority review voucher was denied by the FDA. On this news, the price of bluebird bio stock fell more than 40%, 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 (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.

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.

The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.  

Faruqi & Faruqi, LLP also encourages anyone with information regarding Blue’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

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