Bluebird Exits Europe, Casting Clouds Over Gene Therapy Commercial Effort

The company will prioritize US market for gene therapies; FDA also placed eli-cel for CALD on clinical hold following a case of MDS.

Exit sign
Bluebird is ending its commercial effort in Europe • Source: Alamy

bluebird bio announced two disappointing developments for its gene therapy business, casting a shadow over the planned separation of its gene therapies into a new standalone company in the fourth quarter. The company said it would wind down commercial initiatives for its gene therapy business in Europe after failing for two years to secure reimbursement for its approved gene therapy Zynteglo (betibeglogene autotemcel) for transfusion-dependent beta-thalassemia (TDT).

Bluebird also announced that the US Food and Drug Administration placed a clinical hold on its elivaldogene autotemcel (eli-cel, Lenti-D)...

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