Bluebird Bio Shares Leap Premarket After FDA Clears Skysona

By Colin Kellaher

Shares of bluebird bio Inc. rose sharply in premarket trading Monday after the biotechnology company received accelerated U.S. Food and Drug Administration approval for its Skysona gene therapy for boys with a rare, fatal neurodegenerative disease.

The Somerville, Mass., company said the approval makes Skysona, also known as eli-cel, the first therapy to slow the progression of neurologic dysfunction in boys ages 4 through 17 with early, active cerebral adrenoleukodystrophy.

Bluebird said it agreed to provide confirmatory long-term clinical data to the FDA as a condition of the Skysona accelerated approval, adding that it expects the drug will be available by the end of the year.

Shares of bluebird, which closed Friday at $6.34, were recently up nearly 16% to $7.33 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 19, 2022 06:23 ET (10:23 GMT)

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