Bluebird Bio Surges Following FDA Decision

Shares of bluebird bio, Inc. BLUE surged approximately 10 percent in Monday’s pre-market following the receipt of a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its LentiGlobin BB305 Drug Product for the treatment of transfusion-dependent patients with beta-thalassemia major..

According to the company's press release, LentiGlobin seeks to treat beta-thalassemia major and severe sickle cell disease by inserting a functional human beta-globin gene into the patient's own hematopoietic stem cells ex vivo and then returning those modified cells to the patient through an autologous stem cell transplantation.

"The FDA's Breakthrough designation of LentiGlobin highlights that new therapies are needed for the treatment of patients with beta-thalassemia major, especially treatments with the potential to meaningfully reduce or liberate patients from transfusion dependence," said David Davidson, M.D., chief medical officer of bluebird bio.

bluebird bio, Inc. stock pulled back at the market open and recently traded at $95.78, up 3.09 percent