bluebird bio, Inc.

On December 8, 2023, bluebird announced that it had received approval from the U.S. Food and Drug Administration (“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 every six months as warranted. Additionally, the Company’s anticipated priority review voucher was denied by the FDA.

On this news, bluebird’s stock price fell $1.95, or 40.5%, to close at $2.86 per share on December 8, 2023, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants misled investors by creating the false impression that: (1) they could obtain FDA approval for lovo-cel without any black 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 lovo-cel launch; (3) as a result, the Company had significantly overstated Lyfgenia’s clinical and/or commercial prospects; and (4) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.