Bluebird bio Shares Rise on FDA Priority Review of Beti-cel

 Shares of bluebird bio Inc. rose nearly 10% in premarket trading Monday after the biotechnology company said the U.S. Food and Drug Administration granted priority review to betibeglogene autotemcel, or beti-cel, in the inherited blood disorder beta thalassemia.

The Cambridge, Mass., company said the application covers the use of the gene therapy in adult, adolescent and pediatric patients across all genotypes who require regular red-blood- cell transfusions.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Bluebird said the agency set a target action date of May 20, 2022, for the application.

Bluebird said beti-cel, if approved, would be the first one-time treatment in the U.S. that addresses the underlying genetic cause beta thalassemia, offering an alternative to regular transfusions and iron chelation therapy.

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