Humanigen Inc. (HGEN) stock prices were down by 3.94% as of the market closing on September 8th, 2021. This brought the price per share down to USD$15.11 at the end of the trading day. Subsequent premarket fluctuations saw the stock plummet by 50.96%, bringing it down to USD$7.41.
EUA for Lenzilumab
HGEN stock reported on September 9th, 2021 that the U.S Food and Drug Administration declined the company’s request for EUA. The emergency use authorization submission was for the company’s proprietary lenzilumab. The treatment was hoped to address the demographic of newly hospitalized Covid-19 patients. The clinical-stage biopharmaceutical company has concentrated its efforts to prevent and treat cytokine storm, an immune hyper-response. The FDA declined the EUA submission on the basis of not being able to conclude that the pros of the treatment would outweigh known and potential risks.
HGEN Stock Working with FDA
The United States Food and Drug Administration has committed to collaborating with HGEN stock. This partnership will serve to facilitate the development of lenzilumab. HGEN stock has been invited to submit additional data as it becomes available. The company is looking forward to NIH’s ACTIV-5/BET-B study, which is expected to provide further data. This data is expected to support a new emergency use authorization request. The company continues to allocate resources towards completing regulatory processes for lenzilumab. This is hoped to lead to Marketing Authorization for the company’s treatment for patients in the U.K and abroad.
Working Towards EUA Approval
Lenzilumab is a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Preclinical model projections indicate GM-CSF’s capacity as an upstream regulator of various inflammatory cytokines and chemokines involved in the cytokine storm. Investigations following the onset of the pandemic indicated high levels of GM-CSF secreting T cells to be linked to disease severity and ICU admission. HGEN stock’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab has the potential to prevent consequence of a full blown cytokine storm in hospitalized Covid-19 patients. The company has submitted lenzilumab to Medicines and Health Regulatory Agency in the UK. This submissions is for a rolling review towards potential Marketing Authorization.
Future Outlook for HGEN Stock
The FDA’s declining of EUA for lenzilumab has been a major blow to the company. HGEN stock is poised to leverage its resources towards remedying the situation. Investors are hopeful that management will be able to facilitate the commercialization and proliferation of its flagship treatment. This is hoped to result in significant and sustained increases in shareholder value.
