Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company specializing in the prevention and treatment of immune hyperactivity known as “cytokine storm”, announced today. The FDA has disapproved an application for emergency use of lenzilumab for the treatment of new patients with the virus. Lenzilumab outweighs the known and potential risks of using it to treat COVID19.
The FDA Rejected Humanigen’s Application For The Emergency Use
In the letter, the FDA mentioned that it cannot conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of using it to treat COVID19. The company stated the same verbally as well.
Humanigen hopes that ongoing research will provide additional safety and efficacy data to support its new EUA application.
The company filed an emergency use application with the FDA in May, citing recent test data.
Humanigen also began the UK licensing process in June through an ongoing review process.
Humanigen, Inc., a clinical phase biopharmaceutical company specializing in the prevention and treatment of an increased immune response known as a cytokine storm. This layer binds and deactivates granulocytes, macrophages, and colony-stimulating factors (GMCSF). Results from preclinical models indicate that GMCSF is an upstream regulator of many inflammatory cytokines and chemokines involved in cytokine storms.
The LIVEAIR study showed that early intervention with lenzilumab can prevent the effects of a full-blown cytokine storm in hospitalized COVID19 patients. The human gene has sent lenzilumab to the UK Medicines and Health Administration for ongoing review for a marketing license.
treating COVID19-associated cytokine storm, CART cell therapy targeting CD19, and studying the efficacy of lenzilumab in other inflammatory conditions such as acute host-graft disease in patients undergoing stem cell transplantation and other kinds of different treatments.
All statements in this press release are statements that are forward-looking. Forward-looking statements reflect management’s current knowledge, assumptions, judgments, and expectations regarding future events or results of operations.
While management believes that the expectations expressed in such statements are reasonable, they do not provide any assurance that such expectations will be met, and it should be noted that facts or actual results could differ materially from the expectations set out in the forward-looking statements.
“Plan”, “potential”, “may”, “goal”, “accelerate”, “continue” and similar expressions that define forward-looking statements, including but not limited to statements about the adequacy of ACTIV5 / BETB data examination to support future new applications in the USA statements of our efforts to apply for registration and obtain a marketing license or conditional marketing license for lenzilumab during COVID19 in the UK and other territories; as well as our other plans for lenzilumab, risks and uncertainties, including, but not limited to, risks associated with our inability to generate profits and the need for additional capital to grow our business; our dependence on partners to drive the development of our candidate products; inherent uncertainty for the development, authorization and re-approval of the core requirement and the launch of any new pharmaceutical products; the result of an unfinished or future litigation; as well as various risks and uncertainties described in the Risk Factors section of our most recent annual and quarterly reports and other SEC documents.
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