UPDATED: Bluebird hits the brakes on LentiGlobin studies, Zynteglo marketing after AML, myelodysplastic syndrome cases spur fresh safety concerns
Bluebird bio $BLUE has run into a fresh set of troubles for its gene therapy LentiGlobin.
The biotech, which has seen its gene therapy work mired at the FDA due to CMC issues, revealed Tuesday morning it had suspended work on its early-stage study as well as the Phase III sickle cell trial for LentiGlobin in order to investigate two more serious side effects among patients in the program.
In addition, bluebird CEO Nick Leschly hit the brakes on marketing Zynteglo (betibeglogene autotemcel; beti-cel) in Europe, where it’s approved for beta thalassemia, because it uses the same BB305 lentiviral vector used in the gene therapy for sickle cell disease.
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