- German clinical-stage biopharma InflaRx ( NASDAQ: IFRX ) on Thursday said it had submitted an emergency use approval request to the U.S. FDA for its monoclonal antibody vilobelimab to treat critically ill COVID-19 patients.
- The company also said it was granted a fast track designation from the U.S. drug regulator for vilobelimab.
- IFRX stock +5.6% to $2.63 in early trading.
- The submission for the emergency use nod and the fast track clearance was based on the results of phase 3 studies conducted in invasively mechanically ventilated, critically ill COVID patients, IFRX said in a statement .
- The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
- The submission from InflaRx ( IFRX ) comes at a time when COVID cases in the U.S. are expected to rise in the fall and winter season.
For further details see:
InflaRx seeks FDA emergency use nod for its treatment for critically ill COVID-19 patients