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Bluebird, awaiting FDA feedback, says it’s likely to miss filing goal for sickle cell gene therapy

March 29, 2023


Bluebird is now several months into launching two rare disease gene therapies for which it won FDA approval last fall. But its progress on that front was overshadowed Wednesday by news of the delay for the company’s sickle cell treatment, which is viewed by analysts and investors as more consequential to its future success as a business.

Bluebird expects the delay to be slight, emphasizing that it continues to forecast an expedited FDA review of lovo-cel and, if approved, an early 2024 launch. Still, it’s another setback for a program that’s hit a number of clinical and safety-related hurdles as it has progressed through development.

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