FDA lifts clinical holds on LentiGlobin studies

Shares of US biotech bluebird bio (Nasdaq: BLUE) jumped more than 7% pre-market today, after it announced that the US Food and Drug Administration had lifted the clinical holds on several studies with its gene therapy LentiGlobin. The stock drifted back after regular trading started.

The clinical holds applied to the Phase I/II HGB-206 and Phase III HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) for adult and pediatric patients with SCD, and the Phase III Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of betibeglogene autotemcel gene therapy (beti-cel; licensed as Zynteglo in the European Union and the UK) for adult, adolescent and pediatric patients with transfusion-dependent β-thalassemia (TDT).

The company is working closely with study investigators and clinical trial sites to resume all study activities as soon as possible. In a conversation with SVB Leerink Research analyst Dr Mani Foroohar, bluebird indicated that US TDT regulatory filing timelines remain on track for mid-year (thus – quite near term).