FDA approves bluebird bio's Zynteglo gene therapy for beta thalassemia; shares up 7%

Md Saiful Islam Khan

Note: This article has been updated with bluebird bio share movement and the company's reimbursement program with payers.

• The U.S. FDA has approved bluebird bio's (NASDAQ:BLUE) Zynteglo (betibeglogene autotemcel), a gene therapy for the treatment of the blood disorder β-thalassemia.
• Shares are up 7% in Wednesday afternoon trading.
• In June, an FDA advisory panel voted 13-0 in favor of approval of the treatment.
• Bluebird has set a price tag of $2.8M for the one-time therapy. The company added that private and government payers will be reimbursed the cost of Zyntego if a patient fails to maintain transfusion independence up to two years following infusion.
• Zynteglo, also known as beti-cel, is considered a significant improvement in treatment for β-Thalassemia, which requires regular blood transfusions.
• Trading in bluebird bio (BLUE) was halted at 1241p ET with news pending. Shares began trading again at 230p.
• Year to date, shares are down 32%.
• Read Seeking Alpha contributor Terry Chrisomalis' very bullish case for bluebird bio (BLUE).