![]() We are committed to fully assessing these cases in partnership with the healthcare providers supporting our clinical studies and appropriate regulatory agencies. “The safety of every patient who has participated in our studies or is treated with our gene therapies is the utmost priority for us. ![]() Nick Leschly, CEO of Bluebird Bio, said this about the news hammering BLUE stock today. This is the company’s treatment with betibeglogene autotemcel for transfusion-dependent β-thalassemia. The company is also erring on the side of caution and has paused marketing of Zynteglo. ![]() 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).īluebird Bio says that it’s working with regulators as it investigates these two cases. That includes its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies. 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).
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |