U.S. Markets closed
  • S&P 500

    4,280.15
    +72.88 (+1.73%)
     
  • Dow 30

    33,761.05
    +424.35 (+1.27%)
     
  • Nasdaq

    13,047.19
    +267.29 (+2.09%)
     
  • Russell 2000

    2,016.62
    +41.36 (+2.09%)
     
  • Crude Oil

    91.88
    -0.21 (-0.23%)
     
  • Gold

    1,818.90
    +3.40 (+0.19%)
     
  • Silver

    20.83
    +0.14 (+0.66%)
     
  • EUR/USD

    1.0263
    -0.0063 (-0.6055%)
     
  • 10-Yr Bond

    2.8490
    -0.0390 (-1.35%)
     
  • Vix

    19.53
    -0.67 (-3.32%)
     
  • GBP/USD

    1.2132
    -0.0071 (-0.5787%)
     
  • USD/JPY

    133.4400
    +0.4410 (+0.3316%)
     
  • BTC-USD

    24,321.69
    -89.88 (-0.37%)
     
  • CMC Crypto 200

    574.64
    +3.36 (+0.59%)
     
  • FTSE 100

    7,500.89
    +34.98 (+0.47%)
     
  • Nikkei 225

    28,546.98
    +727.68 (+2.62%)
     

InflaRx Provides Development Update For Vilobelimab In Skin Disorder, COVID-19

  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • InflaRx N.V. (NASDAQ: IFRXprovided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19.

  • The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to vilobelimab for PG.

  • PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin.

  • In addition, the company had a productive FDA end-of-phase II meeting to its plans for a Phase 3 development program in PG.

  • The FDA indicated its support for a randomized, controlled Phase 3 study and offered to review the study protocol.

  • Based on the agency's feedback and recommendations, InflaRx is now finalizing the design for a Phase 3 trial.

  • InflaRx requested a meeting with the FDA to obtain guidance for a potential emergency use authorization submission of vilobelimab in COVID-19 patients.

  • Related: InflaRx Shares Plunge After Disappointing Results On Vilobelimab In Critically Ill COVID-19 Patients.

  • This has been scheduled as a Type B meeting for early Q3. In addition, the company is in ongoing dialogue with the EMA about the next steps in developing vilobelimab in mechanically ventilated severe COVID-19 patients.

  • Price Action: IFRX shares were down 6.91% at $1.42 during the market session on the last check Wednesday.

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.