Bluebird Bio Shares Halted as FDA Committee Meets to Discuss Applications
June 09 2022 - 6:50AM
Dow Jones News
By Chris Wack
Nasdaq has halted trading of bluebird bio Inc.'s common stock on
Thursday and Friday while a U.S. Food and Drug Administration
committee meets to discuss two biologics licensing applications,
the company said Thursday.
The FDA's Cellular, Tissue, and Gene Therapies Advisory
Committee is meeting to discuss applications for betibeglogene
autotemcel and elivaldogene autotemcel, or beti-cel and eli-cel,
bluebird said.
Beti-cel is under review for the treatment of people with
<BETA>-thalassemia who require regular red blood cell
transfusions. Eli-cel is under review for the treatment of early
active cerebral adrenoleukodystrophy in patients less than 18 years
of age who do not have an available and willing human leukocyte
antigen-matched sibling hematopoietic stem cell donor.
The Prescription Drug User Fee Act goal dates for a decision on
approval of beti-cel for people with beta-thalassemia who require
regular red blood cell transfusions and eli-cel for patients with
early active CALD without a matched sibling donor are Aug. 19,
2022, and Sept. 16, 2022, respectively.
The stock was up 3.5%, to $3.86, in premarket trading before the
halt took place at 6:55 a.m. ET.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
June 09, 2022 07:35 ET (11:35 GMT)
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