InflaRx Scores FDA Emergency Use Nod For COVID Antibody

  • InflaRx NV's IFRX stock is up Wednesday morning as the FDA granted emergency-use authorization to its monoclonal antibody for hospitalized COVID patients when initiated within 48 hours of receiving artificial life support.
  • Vilobelimab, which will be sold under Gohibic, was cleared for use in hospitalized adults within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
  • The recommended dosage of Gohibic is 800 mg, administered by intravenous infusion after dilution, given up to six times over the treatment period.
  • Last year in March, the drug failed a topline readout in critically ill intubated patients with COVID-induced pneumonia based on a site-stratified analysis of 28-day all-cause death
  • However, in a predefined analysis without site stratification, InflaRx later reported that "vilobelimab significantly reduced all-cause mortality at 28 days."
  • Germany-based InflaRx is continuing discussions with the FDA related to the submission of an application for full approval of Gohibic in this COVID-19 indication.
  • InflaRx is continuing to develop vilobelimab in other indications, including pyoderma gangrenosum, for which the company is currently initiating a Phase 3 trial.
  • Price Action: IFRX shares are up 21.75% at $4.59 during the premarket session on the last check Wednesday. The company's stock closed 83.90% higher at $3.77 on Tuesday.
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