Bluebird Bio To Withdraw Marketing Of Skysona Gene Therapy In Europe

Bluebird Bio Inc BLUE will withdraw the regulatory marketing authorization for Skysona (elivaldogene autotemcel) in the European Union.
The update comes as a part of the company's winding down of operations there.
Bluebird will also withdraw marketing authorization of the biologic in the UK.
Skysona (elivaldogene autotemcel, Lenti-D), one-time gene therapy, is indicated for early cerebral adrenoleukodystrophy (CALD) in patients under 18 years of age with an ABCD1 genetic mutation.
Adrenoleukodystrophy (ALD) is a disease linked to the X chromosome due to fatty acid buildup caused by a defect in the very long chain of fatty acids transporter in peroxisomes, resulting in damage to the myelin sheath of the nerves, hence seizures and hyperactivity.
In addition, the company will withdraw authorizations for Zynteglo (betibeglogene autotemcel) in the EU and UK in early 2022.
The company does not intend to initiate any new trials in Europe for beta-thalassemia, cerebral adrenoleukodystrophy, or sickle cell disease programs.
Related: Bluebird Bio's Shares Drop To 52-Week Low After Another Gene Therapy Trial Placed On FDA Hold.
Price Action: BLUE shares are up 0.81% at $21.15 during the market session on the last check Thursday.