- InflaRx ( NASDAQ: IFRX ) stock rose ~13% on July 26 after its CEO Niels Riedemann said the company plans to submit a request for an emergency use authorization (EUA) of its COVID-19 drug vilobelimab in the U.S. by the end of Q3.
- The Germany company said it had encouraging interactions with the U.S. Food and Drug Administration (FDA) at a recent Type B meeting which was held to discuss a potential EUA filing and the development of monoclonal antibody vilobelimab for critically ill invasively mechanically ventilated patients with COVID-19.
- InflaRx noted that it discussed in detail a completed phase 3 part of the PANAMO study in invasively mechanically ventilated, critically ill patients with COVID-19.
- In March, the company reported data from the phase 3 trial in which vilobelimab did not show statistical significance in reducing risk of death in mechanically ventilated patients with COVID-19.
- "Our constructive interactions with the FDA and the helpful guidance they provided have encouraged us to move forward with applying for EUA for vilobelimab in critically ill COVID-19 patients," said InflaRx Founder and CEO Riedemann.
For further details see:
InflaRx stock rises 13% on plans to file EUA for COVID drug in US for critically ill patients