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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