Shares of Bluebird Bio Inc. BLUE, -23.93% were down 21.6% in premarket trading on Monday after the company announced several setbacks to its business as part of its second-quarter earnings announcement. Bluebird plans to wind down its gene therapy operations in Europe, citing “European payers,” which are primarily governments there. “European payers have not yet evolved their approach to gene therapy in a way that can recognize the innovation and the expected life-long benefit of these products,” Bluebird executive Andrew Obenshain said in a news release. The company said it may license its three investigational gene therapies to a European company. Bluebird also said the Food and Drug Administration had placed a hold on its experimental Eli-cel product after a possible adverse event from a Phase 3 clinical study. Bluebird plans to complete its submission to the U.S. regulator sometime this year when the hold is lifted. Eli-cel, or elivaldogene autotemce, is a treatment for cerebral adrenoleukodystrophy, a rare disease that affects young boys. Bluebird’s stock is down 42.1% for the year, while the broader S&P 50 SPX, -0.01% is up 18.2%.
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