9 September 2021 - - The US FDA has declined US-based biopharmaceutical company Humanigen, Inc's (NASDAQ: HGEN) request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients, the company said.

In its letter, FDA said that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19.

Humanigen, Inc. (NASDAQ: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called 'cytokine storm'.

Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF).

Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm.

Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission.

Humanigen's Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

Humanigen has submitted lenzilumab to Medicines and Health Regulatory Agency in the United Kingdom for a rolling review towards potential Marketing Authorization.

Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19, CD19-targeted CAR-T cell therapies and exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis.