Humanigen files for EUA for lenzilumab in COVID-19

Californian cytokine storm syndrome specialist Humanigen (Nasdaq: HGEN) on Friday announced it has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for lenzilumab for the treatment of patients hospitalized with COVID-19.

This EUA application follows positive results from the LIVE-AIR Phase III clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients. News of the progress saw a surprising 11% decline to $20.23 in Humanigen’s shares by close of trading on Friday.

“Filing for EUA in the US is a critical step to making a therapeutic option available for COVID-19,” said Dr Cameron Durrant, chief executive of Humanigen, adding: “There is a need for therapies for hospitalized patients who require supplementary oxygen. Treatments can be lifesaving; despite vaccinations, infections and significant breakthrough disease will continue. Lenzilumab, should the FDA grant authorization, can address a critical unmet need for an effective treatment. We are extremely grateful to the investigative team and volunteers in the clinical trial program, as their involvement was vital in delivering this positive Phase III study.”