Benzinga | Jun 7, 2021 09:53AM EDT

FDA Gives Signal to Halted Bluebird Bio's Gene Therapy Trials In Sickle Cell Disease, Thalassemia

* The FDA has lifted the clinical hold on Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of Bluebird Bio Inc's (NASDAQ:BLUE) LentiGlobin for sickle cell disease and two Phase 3 studies of betibeglogene autotemcel gene therapy for transfusion-dependent ?-thalassemia.

* The company is working closely with study investigators and clinical trial sites to resume all study activities as soon as possible.

* In March, the company said that based on the analyses completed to date, it is very unlikely the suspected unexpected serious adverse reaction of acute myeloid leukemia in its Phase 1/2 study of LentiGlobin was related to the BB305 lentiviral vector.

* Later, the company revised the diagnosis for the previously reported case of myelodysplastic syndrome (MDS) in its Phase 1/2 study of LentiGlobin.

* The further assessment concluded this is not a case of MDS and revised the diagnosis to transfusion-dependent anemia.

* Price Action: BLUE shares are up 1.5% at $31.38 during the market session on the last check Monday.