See Why Humanigen Stock Is Plunging To 52-Week Low - Humanigen Inc (OTC:HGEN)

The FDA declined Humanigen Inc's HGEN request for emergency use authorization (EUA) of its lenzilumab drug to treat newly hospitalized COVID-19 patients.
The Company filed its application with the FDA for emergency drug use in May, citing late-stage trial data.
Related Content: Humanigen Files U.S. Emergency Use Application For Lenzilumab For COVID-19.
"In its letter, FDA stated 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 expects an ongoing study in around 500 patients to provide additional safety and efficacy data to support its new EUA request.
Read Next: Humanigen's COVID-19 Candidate Shows 2.5 Fold Increase In Survival Without Ventilation.
Humanigen also started the process of U.K. authorization for the drug in June through a rolling review submission.
Also Read: Lenzilumab Application Is Under Review In U.K. For COVID-19.
Price Action: HGEN stock is down 53.70% at $7 during the premarket session on the last check Thursday.