BLUE - bluebird bio suspends sickle cell disease trial; shares drop 26%

bluebird bio (BLUE) has lost ~25.8% in premarket after the company announced the temporary suspension of two clinical trials for its gene therapy candidate, LentiGlobin, and the marketing of ZYNTEGLO™ gene therapy, approved in Europe for transfusion-dependent ?-thalassemia.The decision to halt Phase 1/2 (HGB-206) and Phase 3 (HGB-210) for LentiGlobin in sickle cell disease (“SCD”) (bb1111) was taken due to a suspected unexpected serious adverse reaction (“SUSAR”) of acute myeloid leukemia (“AML”), the company said.A patient who received the experimental therapy more than five years ago in Group A of HGB-206 was diagnosed with AML. The investigations are ongoing to determine if the cause had any relationship to the use of BB305 lentiviral vector in the manufacture of LentiGlobin for SCD.Though no cases of hematologic malignancy have been reported in any patient who has received ZYNTEGLO, the company has decided to temporarily suspend its marketing as ZYNTEGLO is also manufactured using the same BB305

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bluebird bio suspends sickle cell disease trial; shares drop 26%