Bluebird bio Shares Plumb New Lows After FDA Extends Reviews
January 18 2022 - 2:26PM
Dow Jones News
By Colin Kellaher
Shares of bluebird bio hit an all-time low on Tuesday after the
Food and Drug Administration extended by three months its reviews
of two of the biotechnology company's drug candidates.
The Cambridge, Mass., company said the FDA pushed the target
action date for betibeglogene autotemcel, or beti-cel, for the
inherited blood disorder beta thalassemia to Aug. 19 and the date
for elivaldogene autotemcel, or eli-cel, for the genetic disorder
cerebral adrenoleukodystrophy to Sept. 16.
Bluebird said the extensions give the FDA more time to review
information it submitted at the agency's request, which was deemed
a major amendment to the company's applications.
Bluebird also said it received written questions from the FDA
related to the partial clinical hold the agency imposed last month
on the company's clinical program for lovotibeglogene autotemcel,
or lovo-cel, in sickle-cell disease. The company said it is still
evaluating the potential impact of the partial hold on its prior
plan to file for FDA approval of the gene therapy in the first
quarter of next year, adding that it will give an update when it
reports its 2021 results late next month.
Bluebird shares were recently changing hands at $7.99, down
8.5%, after earlier hitting $7.96, their lowest level since the
company went public in 2013.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 18, 2022 14:11 ET (19:11 GMT)
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