U.S. Markets closed
  • S&P 500

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

    35,911.81
    -201.79 (-0.56%)
     
  • Nasdaq

    14,893.75
    +86.95 (+0.59%)
     
  • Russell 2000

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

    84.34
    +0.52 (+0.62%)
     
  • Gold

    1,816.20
    -0.30 (-0.02%)
     
  • Silver

    22.92
    +0.00 (+0.01%)
     
  • EUR/USD

    1.1416
    0.0000 (-0.0000%)
     
  • 10-Yr Bond

    1.7720
    +0.0610 (+3.57%)
     
  • Vix

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

    1.3674
    -0.0006 (-0.0438%)
     
  • USD/JPY

    114.4080
    +0.2080 (+0.1821%)
     
  • BTC-USD

    42,928.24
    -167.97 (-0.39%)
     
  • CMC Crypto 200

    1,034.45
    +8.72 (+0.85%)
     
  • FTSE 100

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

    28,292.20
    +167.92 (+0.60%)
     

Fast Track Status Expanded For Inventiva's NASH Treatment

  • 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 decided that the Fast Track designation previously granted to Inventiva SA's (NASDAQ: IVA) lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

  • The decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August.

  • Previously, the agency granted both Fast Track and Breakthrough Therapy designations to lanifibranor for NASH treatment in September 2019 and October 2020, respectively.

  • The Company has initiated a NATiV3 Phase 3 trial evaluating lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis.

  • The patient screening started on September 8.

  • Cash and cash equivalents stood at €93.6 million as of June 30, 2021.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: IVA stock closed 0.36% lower at $13.93 on Tuesday.

See more from Benzinga

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