InflaRx Scores FDA Emergency Use Nod For COVID Antibody

Loading...
Loading...
  • 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.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsPenny StocksHealth CareFDAMoversGeneralBriefsCOVID-19 Coronaviruswhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...