U.S. Markets closed
  • S&P 500

    4,662.85
    +3.82 (+0.08%)
     
  • Dow 30

    35,911.81
    -201.81 (-0.56%)
     
  • Nasdaq

    14,893.75
    +86.94 (+0.59%)
     
  • Russell 2000

    2,162.46
    +3.02 (+0.14%)
     
  • Crude Oil

    84.27
    +2.15 (+2.62%)
     
  • Gold

    1,817.30
    -4.10 (-0.23%)
     
  • Silver

    22.99
    -0.17 (-0.74%)
     
  • EUR/USD

    1.1416
    -0.0044 (-0.3881%)
     
  • 10-Yr Bond

    1.7720
    +0.0610 (+3.57%)
     
  • Vix

    19.19
    -1.12 (-5.51%)
     
  • GBP/USD

    1.3680
    -0.0030 (-0.2216%)
     
  • USD/JPY

    114.2000
    +0.0200 (+0.0175%)
     
  • BTC-USD

    43,013.28
    -57.40 (-0.13%)
     
  • CMC Crypto 200

    1,037.76
    +12.02 (+1.17%)
     
  • FTSE 100

    7,542.95
    -20.90 (-0.28%)
     
  • Nikkei 225

    28,124.28
    -364.85 (-1.28%)
     

Bluebird Bio To Withdraw Marketing Of Skysona Gene Therapy In Europe

·1 min read
  • Bluebird Bio Inc (NASDAQ: 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.

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.