Shares of Bluebird bio Inc. leapt 7.2% in premarket trading after the gene therapy company said the U.S. Food and Drug Administration (FDA) lifted the clinical holds on the company’s trials for its sickle cell disease (SCD) treatments. The lifted hold comes after the treating investigator concluded that the previously reported case of myelodysplastic syndrome (MDS) in its Phase 1/2 study of LentiGlobin for SCD was not a case of MDS, and revised the diagnosis to transfusion-dependent anemia. The company said it is working with study investigators to resume all study activities as soon as possible. “Over the past four months, we have gained deeper knowledge and understanding of the pathophysiology of sickle cell disease that will allow us to better serve patients and the broader community,” said Andrew Obenshain, president of severe genetic diseases at Bluebird. “We look forward to resuming our clinical programs and continuing to advance toward major regulatory submissions for sickle cell disease and β-thalassemia.” The stock has tumbled 28.5% year to date through Friday, while the iShares Nasdaq Biotechnology ETF has gained 1.0% and the S&P 500 has advanced 12.6%.
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