According to the Complaint, bluebird bio, inc. ("bluebird" or the Company) is a clinical-stage biotechnology company committed to developing potentially transformative gene therapies for severe genetic diseases and cancer. The Company is primarily focused on the treatment of sickle cell disease (“SCD”). SCD is a serious, progressively debilitating and life-threatening genetic disease that results from production of abnormal sickle hemoglobin (“HbS”), which leads to sickled red blood cells (“RBCs”) and hemolysis. As a result of this abnormal hemoglobin, many affected individuals live with severe anemia and vaso-occlusive events which include severe, recurrent pain crises that lead to organ damage and shortened life span.
The Company is conducting five clinical studies of its LentiGlobin product candidate, designed to treat SCD, with the stated goal of filing for regulatory approval in the US and EU for different genotypes of TDT and for severe SCD. The Company’s five studies are: (i) a Phase I/II study in the United States, Australia, and Thailand to evaluate its safety and efficacy in the treatment of subjects with TDT, called the Northstar Study (HGB-204); (ii) a multi-site, international, Phase III study to evaluate its safety and efficacy in the treatment of subjects with TDT and a non-?0
/?0 genotype, called the Northstar-2 Study (HGB-207); (iii) a multi-site, international, Phase III study for the treatment of subjects with TDT and a ?0 /?0 genotype, called the Northstar 3 Study (HGB-212); (iv) a single-center Phase I/II study in France to evaluate its safety and efficacy in the treatment of subjects with TDT or with severe SCD (HGB-205); and (v) a multi-site Phase I study in the United States to evaluate its safety and efficacy in the treatment of subjects with severe SCD (HGB-206).
Following treatment with LentiGlobin in the Northstar studies, patients are monitored for production of HbAT87Q, which is gene therapy derived-hemoglobin. The production of HbAT87Q increases the overall hemoglobin level in patients with the goal of reducing or eliminating the need for transfusions.
Throughout the Class Period, the Company stated that its various LentiGlobin studies, including HGB-205, would form the basis of its regulatory approval applications.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. The Complaint specifically alleges that Defendants made false and/or misleading statements and/or failed to disclose that: (i) LentiGlobin when used to treat severe SCD did not produce as much anti-sickling hemoglobin as the Company had previously reported; (ii) accordingly, the Company’s LentiGlobin product was not as effective as previously reported; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.
This case was voluntarily dismissed on December 12, 2018.