Bluebird Bio Shares Halted as FDA Committee Meets to Discuss Applications

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)

bluebird bio (NASDAQ:BLUE)
Historical Stock Chart
From Mar 2024 to Apr 2024