In light of a Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia and a SUSAR of myelodysplastic syndrome in our HGB-206 clinical study reported to us in February 2021, bluebird bio put a clinical hold on our Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease (bb1111). As of February 23, bluebird bio announced that the FDA placed our clinical studies of LentiGlobin for SCD on clinical hold.

The patients are being managed by their physicians and we are keeping them and their families in our thoughts. There is nothing more important to us than the health and safety of each and every patient who has participated in our clinical studies or received our gene therapies. We are inspired by their stories and thank them for their courage.

We are taking these cases very seriously and are in ongoing dialogue with regulatory authorities as well as the physicians who are investigators in our clinical studies to fully assess the cause of these events. We are working hard to get answers and will continue to communicate with as much transparency as possible as information becomes available. We want to thank the entire patient community for your support and patience during this time.