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 BLUE LentiGlobin for sickle cell disease and two Phase 3 studies of betibeglogene autotemcel gene therapy for transfusion-dependent β-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.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsgene therapySickle Cell Disease
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