Faruqi & Faruqi, LLP investigates claims

NEW YORK, May 8, 2024 (GLOBE NEWSWIRE) — Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating and reminds investors of potential claims against bluebird bio, Inc. (“Blue” or the “Company”) (NASDAQ: BLUE ). to the May 28, 2024 deadline to seek the role of lead plaintiff in a federal securities class action lawsuit filed against the Company.

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson encourages investors who have suffered losses of more than $100,000 in Blue to contact him directly to discuss their options

If you suffered losses of more than $100,000 by investing in Blue stocks or options between April 24, 2023 and December 8, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi Partners Josh Wilson directly at 877-247-4292 or 212-983-9330 (ext. 1310). For more information you can also click here: www.faruqilaw.com/BLUE.

Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The company 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 throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) they received FDA approval for lovo-cel without warnings for hematological malignancies; (2) They would receive a priority review voucher from the FDA and in turn sell it to strengthen their financial position for the introduction of Lovocel. (3) as a result, the Company had materially 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 also alleges that on December 8, 2023, bluebird bio disclosed that: (i) the Company had received FDA approval for its ex vivo gene therapy drug Lyfgenia for sickle cell anemia; (ii) along with the approval came a black box warning for hematologic malignancies with the requirement to monitor patients for cancer by complete blood count at least every 6 months for at least 15 years, plus viral vector integration site analysis in the 6th and 12th days. month, and how justified; and (iii) bluebird bio’s expected priority review voucher was rejected by the FDA. According to the complaint, the price of Bluebird organic shares fell more than 40% on this news.

On April 24, 2023, Defendants announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the gene therapy Lovo-Cel (Lovotibeglogene Autotemcel) in patients with sickle cell disease (SCD) at age 12 years and older who have experienced vaso-occlusive events (VOEs) in the past. The BLA also included a request for priority review, which, if granted, would shorten FDA’s review of the application to six months from the time of submission, compared to a standard review period of 10 months.

On December 8, 2023, Blue issued a press release announcing that the Company received FDA approval for its ex vivo gene therapy drug Lyfgenia for sickle cell anemia. Approval was accompanied by a black box warning for hematologic malignancies, with a requirement to monitor patients for cancer at least every six months for at least 15 years by complete blood count, plus viral vector integration site analysis at months 6, 12, and if necessary. Additionally, the company’s expected priority review voucher was rejected by the FDA.

As a result of this news, the price of Blue’s common stock decreased from a closing 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 greatest financial interest in the relief sought by the class, who is appropriate and typical of the class, and who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may request the Court to serve as lead plaintiff through counsel of their choice, or may elect to do nothing and remain an absent class member. Your ability to participate in any recovery will not be affected by the decision to serve as lead plaintiff or not.

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

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