No stranger to headwinds, bluebird runs into two PDUFA delays unrelated to new safety issues

Bluebird bio hit another speed bump Tuesday in its efforts to win its first FDA approvals as regulators pushed back two PDUFA dates.

The FDA delayed the action dates for beti-cel and eli-cel, the one-time gene therapies for beta-thalassemia and cerebral adrenoleukodystrophy, by three months each, the biotech said in a press release Tuesday morning. Originally scheduled for May and June, respectively, the new PDUFA dates were pushed back to August and September.