The US Food and Drug Administration (FDA) granted emergency-use authorization (EUA) to InflaRx NV's monoclonal antibody for the treatment of hospitalized Covid-19 patients, sending the company’s stock soaring.
Shares of the German biopharmaceutical company skyrocketed nearly 60% to $6.02 on Wednesday.
InflaRx’s injection, known as Gohibic, works by targeting a part of the immune system that is thought to play a role in the inflammation that leads to Covid-19 disease progression. The EUA application is meant for patients within 48 hours of receiving artificial life support.
The recommended dosage of Gohibic is 800 mg administered by intravenous infusion after dilution, given up to six times over the treatment period, the FDA said in a statement.
The data behind the FDA’s decision comes from a late-stage trial showing that patients treated with Gohibic had a lower risk of death by day 28 and day 60 of treatment compared with a placebo.
InflaRx is in discussion with the FDA about submitting an application for full approval of Gohibic in this Covid-19 indication.
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