After FDA Rejection, Humanigen's COVID-19 Drug Hopeful Sees Some Light Of Good News

Humanigen Inc HGEN announced that The Lancet Respiratory Medicine published results from its LIVE-AIR Phase 3 trial of lenzilumab in hospitalized COVID-19 patients.

• The Lancet paper concludes, "LIVE-AIR showed that lenzilumab treatment of hospitalized patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile similar to that of placebo." 
• Results of the LIVE-AIR Phase 3 trial demonstrate lenzilumab results in a statistically significant 54% relative improvement in the likelihood of survival without the need for invasive mechanical ventilation.
• Lenzilumab is a variant-agnostic therapeutic that targets the dysregulated host immune response, said Cameron Durrant, Chairman & CEO, Humanigen.
• According to the paper, '60% of LIVE-AIR patients were on room air or low-flow oxygen support...(Raising) the possibility of lenzilumab might be positioned for use before ICU admission and progression of respiratory failure requiring high-flow oxygen and non-invasive or invasive ventilation.'
• Lenzilumab is a proprietary Humaneered first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in cytokine release syndrome associated with COVID-19 and other indications. 
• In September, FDA declined Humanigen's request for emergency use authorization of its lenzilumab for newly hospitalized COVID-19 patients.
• Price Action: HGEN shares are up 9.16% at $6.08 during the premarket session on the last check Thursday.