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Bluebird Expects Three Filings In 2020, But US Zynteglo Submission Pushed Back

 
• By Mandy Jackson

A BLA filing for Zynteglo in beta-thalassemia is expected in the second half of 2020 instead of the first half, but the first commercial patient in the EU will be treated in the first half of this year.

Close up of old English dictionary page with word behind schedule
While delayed, Zynteglo will be one of three US filings for bluebird in 2020 • Source: Shutterstock

bluebird bio Inc. will have an eventful 2020, including the submission of three different products for regulatory approvals, but at least one milestone will be reached a little later than previously expected.

The company launched its gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) in the EU, where it was approved for transfusion-dependent beta-thalassemia (TDT) in June, and will treat its...

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