Summary
- bluebird bio's Zynteglo receives positive CHMP opinion for approval of Zynteglo to treat transfusion dependent beta-thalassemia patients.
- The European Commission is expected to make its final decision for potential European approval of Zynteglo by Q2 of 2019.
- A major risk for bluebird bio will be finding the right pricing strategy if it does receive regulatory approval of Zynteglo.
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bluebird bio (BLUE) is one step closer to potentially obtaining European approval for its gene therapy Zynteglo. That's because the Committee for Medicinal Products for Human Use (CHMP) recommended that the gene therapy product should be approved for the European Union. If bluebird gets approval for the gene therapy, that would be a welcomed news for patients. In addition, the biotech is making strides to gain FDA approval in the United States for the very same gene therapy next year.
