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Case Status:    ONGOING    
On or around 03/28/2024 (Date of last review)

Filing Date: March 28, 2024

According to the Complaint, bluebird bio, Inc. is a biotechnology company that researches, develops, and commercializes gene therapies for severe genetic diseases.

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.

The Complaint alleges that the Company’s announcement provided investors with false and misleading information in order to bolster investor expectations and share prices. Specifically, the Complaint alleges Defendants created the false impression that: (i) they could obtain FDA approval for lovocel 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, and that as a result, Plaintiff and other shareholders purchased the Company’s securities at artificially inflated prices.

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