Bluebird announces FDA approval of gene therapy for rare blood disease


Shares of Buebird Bio Inc. BLUE, +3.04% jumped 12.1% in trading on Wednesday after the Food and Drug Administration approved the company’s gene therapy as a treatment for beta‑thalassemia in some adult and pediatric patients. Beta-thalassemia is a rare, genetic blood disease, and the patients who qualify for the treatment require regular red blood cell transfusions. The one-time wholesale acquisition price for Zynteglo is $2.8 million. Bluebird also announced an outcomes-based agreement in which the company will reimburse commercial and government payers up to 80% of the total cost if a patient fails to stay transfusion-free for two years. Bluebird’s stock has tumbled 25.9% so far this year, while the broader S&P 500 SPX, -0.72% is down 9.6%. fdsup://factset/Doc%20Viewer%20Single?_expand=oE8Pv7&float_window=true EST (833-888-6378) for more information, and additional details will be available at in the coming days. ZYNTEGLO was reviewed under Priority Review, and the Company received a Priority Review voucher upon approval. ZYNTEGLO was previously granted Orphan Drug designation and Breakthrough Therapy designation.

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