U.S. markets open in 2 hours 51 minutes
  • S&P Futures

    4,158.50
    +11.75 (+0.28%)
     
  • Dow Futures

    32,842.00
    +85.00 (+0.26%)
     
  • Nasdaq Futures

    13,282.25
    +53.50 (+0.40%)
     
  • Russell 2000 Futures

    1,926.20
    +4.40 (+0.23%)
     
  • Crude Oil

    87.96
    -1.05 (-1.18%)
     
  • Gold

    1,793.10
    +1.90 (+0.11%)
     
  • Silver

    20.10
    +0.26 (+1.33%)
     
  • EUR/USD

    1.0188
    +0.0001 (+0.01%)
     
  • 10-Yr Bond

    2.8400
    0.0000 (0.00%)
     
  • Vix

    21.78
    +0.34 (+1.59%)
     
  • GBP/USD

    1.2088
    +0.0018 (+0.15%)
     
  • USD/JPY

    134.9200
    -0.0500 (-0.04%)
     
  • BTC-USD

    24,076.99
    +1,063.37 (+4.62%)
     
  • CMC Crypto 200

    560.25
    +25.02 (+4.68%)
     
  • FTSE 100

    7,473.49
    +33.75 (+0.45%)
     
  • Nikkei 225

    28,249.24
    +73.37 (+0.26%)
     

Astellas's Pompe Disease Gene Therapy Trial Put On FDA Clinical Hold

  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • The FDA has placed a clinical hold on Astellas Pharma Inc's (OTC: ALPMY) FORTIS Phase 1/2 trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants.

  • FORTIS trial is evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adults with Late-Onset Pompe Disease.

  • The FDA has informed Astellas that it did not have sufficient information to assess the risks to subjects and requires additional information about the recently reported SAE.

  • To date, the site investigator has classified the SAE as Grade 1 (mild in severity) and deemed serious due to medical significance.

  • Astellas is working closely with the site investigator to follow the patient's clinical course and will continue gathering and reviewing all relevant data.

  • All enrolled participants will continue to be monitored closely per the study protocol.

  • Astellas is reviewing the potential financial impacts of this matter for the fiscal year ending March 31, 2023.

See more from Benzinga

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.