Shares of Bluebird Bio Inc. were rising in Friday’s after-hours market, following news that a U.S. Food and Drug Administration Committee supported two of the company’s gene therapies to treat various conditions.
At 5:02 p.m. ET, the company’s shares had risen 62.4% to trade at $6.01 per share. Volume at the time topped 3.5 million shares.
Trade in the company’s shares had been halted on Thursday and in Friday’s regular session due to pending news. Trade resumed after hours Friday.
on Thursday said a U.S. Food and Drug Administration committee endorsed elivaldogene autotemcel gene therapy to treat certain patients with early active cerebral adrenoleukodystrophy.
According to Bluebird, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee unanimously voted yes on the question, “Do the benefits of eli-cel outweigh the risks, for the treatment of any sub-population of children with early active cerebral adrenoleukodystrophy?” The company also said eli-cel, if it is approved, will be “the first approved gene therapy to address the underlying genetic cause of disease for patients living with CALD in the U.S.”
On Friday, the committee gave its support for beti-cel gene therapy for patients with beta-thalassemia who require regular red blood cell transfusions, Bluebird said. The answered with 13 yes votes to zero no votes on the question, “Do the benefits of beti-cel outweigh the risks for the treatment of subjects with transfusion-dependent beta-thalassemia?” Bluebird said.
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