Bluebird sinks after Lyfgenia gets boxed warning, review voucher denied

Bluebird Bio said that while Lyfgenia was granted priority review in June, the company did not receive a Rare Pediatric Disease Priority Review Voucher as part of the review. On October 30, Bluebird entered into an agreement to sell the Rare Pediatric Disease Priority Review Voucher if received, for $103M. Bluebird shares are sinking after the FDA approved Lyfgenia for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events. Along with not getting the Rare Pediatric Disease Priority Review Voucher, Lyfgenia’s label included a boxed warning for hematologic malignancy. Shares of Bluebird Bio are down 40%, or $1.94, to $2.87 in afternoon trading.