U.S. markets closed
  • S&P 500

    4,482.73
    -50.03 (-1.10%)
     
  • Dow 30

    34,715.39
    -313.26 (-0.89%)
     
  • Nasdaq

    14,154.02
    -186.23 (-1.30%)
     
  • Russell 2000

    2,024.04
    -38.75 (-1.88%)
     
  • Crude Oil

    86.29
    -0.61 (-0.70%)
     
  • Gold

    1,840.20
    -2.40 (-0.13%)
     
  • Silver

    24.48
    -0.24 (-0.98%)
     
  • EUR/USD

    1.1315
    -0.0032 (-0.28%)
     
  • 10-Yr Bond

    1.8330
    +0.0060 (+0.33%)
     
  • GBP/USD

    1.3595
    -0.0016 (-0.12%)
     
  • USD/JPY

    113.9720
    -0.3810 (-0.33%)
     
  • BTC-USD

    40,883.38
    -965.60 (-2.31%)
     
  • CMC Crypto 200

    992.43
    -2.83 (-0.28%)
     
  • FTSE 100

    7,585.01
    -4.65 (-0.06%)
     
  • Nikkei 225

    27,772.93
    +305.70 (+1.11%)
     

FDA Not In Favor Of Summit Therapeutics' Endpoint Change To Pivotal Infection Trials

  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • SMMT
  • Summit Therapeutics Inc (NASDAQ: SMMT) announced that the FDA disagrees with its proposed change to the primary endpoint in Phase 3 Ri-CoDIFy studies.

  • In a regulatory filing, the Company said that the federal agency does not agree with its proposed change to the primary endpoint implemented in the ongoing trials.

  • In August, Summit said that the two blinded pivotal Phase 3 trials would be combined into a single study.

  • The trials were designed to evaluate ridinilazole versus vancomycin for Clostridioides difficile infection.

  • The trial's primary endpoint seeks to prove ridinilazole's superiority in sustained clinical response compared to vancomycin.

  • The Company plans to disclose the combined results of the study when topline data become available.

  • "These topline results will best inform all parties as to the next appropriate course of action regarding ridinilazole," Summit added in the 8-K filing. The topline data from the trial are expected in Q1 2022.

  • Read Next: Summit Therapeutics Unveils Preclinical Candidate For Multidrug-Resistant Infections.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: SMMT stock dropped 19.7% at $6.48 during after-hours trading on Tuesday.

See more from Benzinga

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