2023-04-05 11:57:18 ET
Shares of InflaRx (NASDAQ: IFRX) were up 48% an hour after the market opened on Wednesday on news the company's COVID-19 therapy was receiving an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). The German clinical-stage biotech focuses on anti-inflammatory therapies.
The healthcare stock jumped to a 52-week high of $7.25 a share in early trading after the FDA approved an EUA for Gohibic (vilobelimab), a monoclonal anti-human complement factor C5a antibody, to treat hospitalized COVID-19 patients within 48 hours of receiving oxygen through a ventilator or through a heart-lung machine. The EUA is based on the company's successful phase 3 study of the drug on 369 hospitalized patients that showed a 23.9% reduction in the mortality rate compared with placebo.
While an EUA is not the same thing as a full approval, it does mean that the company can begin earning revenue from its first marketed product in the meantime.
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Why Shares of InflaRx Are Soaring Wednesday