Why Are Bluebird Bio Shares Trading Lower Today?

  • The FDA has placed a partial clinical hold on Bluebird bio Inc's BLUE lovotibeglogene autotemcel (lovo-cel) gene therapy program for sickle cell disease (SCD) for patients under the age of 18. 
  • The partial, temporary suspension relates to an ongoing investigation by bluebird bio into an adolescent patient with persistent, non-transfusion-dependent anemia following treatment with lovo-cel, now 18 months post-treatment. 
  • The patient is clinically well, and there is no evidence of malignancy or clonal predominance. 
  • Related: Bluebird bio's Neurodegenerative Disease Gene Therapy Under Priority FDA Review, Despite Clinical Hold.
  • Bluebird anticipates receiving written questions from the agency in early 2022. 
  • Enrollment and dosing for patients 18 and older living with SCD in the HGB-206, HGB-210, and LTF-307 clinical studies and follow-up for treated patients of all ages in all studies continue as planned.
  • The Company is evaluating the impact of the partial clinical hold on Q1 of 2023 projected timing for the lovo-cel biologics license application (BLA) submission. 
  • Lovo-cel gene therapy is designed to add functional copies of a modified form of the β-globin gene into a patient's hematopoietic (blood) stem cells.
  • Price Action: BLUE shares are down 20.70% at $8.42 during the premarket session on the last check Monday.
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