Bluebird Bio Inc BLUE shares are trading lower Monday. The stock initially surged in premarket trading following the U.S. Food and Drug Administration's accelerated approval of SKYSONA, but it turned sharply lower at the open.
On Friday, Bluebird announced that SKYSONA was granted accelerated approval from the FDA to slow the progression of neurologic dysfunction in boys 4 to 17 years of age with early, active cerebral adrenoleukodystrophy (CALD).
Nearly half of CALD patients who do not receive treatment die within five years of symptom onset. Prior to the approval of SKYSONA, effective options were limited to treatments associated with the risk of serious potential complications including death.
"For the ALD community, this long-awaited approval represents significant hope and offers families a new option where, for many, there had been none," said Andrew Obenshain, CEO of Bluebird Bio.
Bluebird anticipates that commercial product will be available by the end of 2022. The company also confirmed that the previous clinical hold on its eli-cel clinical development program has been lifted.
BLUE Price Action: Bluebird Bio has a 52-week high of $10.74 and a 52-week low of $2.86.
The stock was down 11.9% at $5.59 at time of publication, according to Benzinga Pro.
Photo: Konstantin Kolosov from Pixabay.
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