Bluebird Bio (NASDAQ:BLUE) stock is diving on Tuesday after announcing a suspension of some of its clinical trials.
Bluebird Bio is putting studies of LentiGlobin gene therapy for sickle cell disease (SCD) on pause as it investigates a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML). That includes its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies.
The halt to the studies comes after reports that a patient treated over five years ago “in Group A of HGB-206 was diagnosed with AML.” To go along with this, the company also notes that another patient from Group C of HGB-206 was diagnosed with myelodysplastic syndrome (MDS).
Bluebird Bio says that it’s working with regulators as it investigates these two cases. The company is also erring on the side of caution and has paused marketing of Zynteglo. This is the company’s treatment with betibeglogene autotemcel for transfusion-dependent β-thalassemia.
Nick Leschly, CEO of Bluebird Bio, said this about the news hammering BLUE stock today.
“The safety of every patient who has participated in our studies or is treated with our gene therapies is the utmost priority for us. We are committed to fully assessing these cases in partnership with the healthcare providers supporting our clinical studies and appropriate regulatory agencies. Our thoughts are with these patients and their families during this time.”
BLUE stock was down 33.7% as of Tuesday afternoon.
On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article.