BLUE - FDA partial clinical hold put on bluebird bio sickle cell gene therapy; shares fall 20%

The FDA has placed a partial clinical hold on bluebird bio's (NASDAQ:BLUE) lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease those under 18. Shares are down 20% in premarket trading. The hold relates to an ongoing investigation into an adolescent patient with persistent, non-transfusion-dependent anemia following treatment with lovo-cel. The patient is now doing well. Despite the setback, bluebird plans to continue follow-up on patients treated from two previous trial to evaluate the efficacy and safety of lovo-cel. Read about recent phase 1/2 results on lovo-cel.

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FDA partial clinical hold put on bluebird bio sickle cell gene therapy; shares fall 20%