bluebird bio, Inc. (BLUE) shares are declining more than 9 percent on Monday morning trade in spite of FDA lifting its partial clinical hold for patients under the age of 18 in the evaluation of lovotibeglogene autotemcel or lovo-cel for sickle cell disease. The company said it plans to resume enrollment and treatment of pediatric and adolescent patients in the first quarter of next year.
The partial hold since December 2021 was related to an investigation by bluebird bio into an adolescent patient with persistent, non-transfusion-dependent anemia following treatment with lovo-cel. The company remains on track to submit a Biologics License Application to FDA for lovo-cel in the first quarter of 2023.
Currently, shares are at $6.97, down 9.48 percent from the previous close of $7.70 on a volume of 838,433.
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