Humanigen, Inc. (OTCMKTS: HGEN) is having an incredible start to the trading session. The stock is trading on gains of more than 10% after announcing that the FDA has approved the emergency use of its COVID-19 treatment. Here’s what’s happening:
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HGEN Stock Heads Up On FDA Approval
In the press release, Humanigen said that its lenzilumab candidate has been approved by the FDA to be administered in COVID-19 patients under individual patient emergency IND applictions under the company’s compassionate use program.
In the release, HGEN also said that it is advancing its plans to conduct a multicenter, Phase III, randomized, double-blinded, controlled, clinical trial with lenzilumab for the prevention of ARDS and/or death in novel coronavirus patients.
In a statement, Dr. Cameron Durrant, CEO at HGEN, had the following to offer:
We are gratified to be able to offer compassionate use of lenzilumab for patients with COVID-19. Humanigen has pioneered the field of GM-CSF neutralization and, unlike other GM-CSF approaches, has already conducted two Phase I and two Phase II studies, including in patients with severe respiratory conditions, with excellent safety results.
Lenzilumab has an excellent safety and tolerability profile and has not been associated with serious adverse events. Prior studies have included patients who are immunosuppressed, as well as patients with severe asthma. We have been working on prevention of cytokine storm for nearly three years. We have published extensively in this field, the mechanism of which has been subsequently reinforced by other companies following our lead in this area. In addition, we have filed extensive IP on GM-CSF neutralization across a wide range of therapeutic areas, including COVID-19.
This News Is Incredible
COVID-19 is changing life as we know it. Here in Florida, the entire state has been placed on a 30-day stay-at-home order, and many other states around the country are doing the same. More than 10 million Americans have lost their jobs, churches have closed, and parents have no idea when their children will be going back to school.
In the midst of this pandemic, the smartest minds in the scientific community are working to stop the spread and reduce the death toll associated with COVID-19. That’s why this news is so important.
Humanigen’s lenzilumab has been proven in various models to reduce or eliminate the risk of cytokine storm. Given that cytokine storm is a precursor to pneumonia and ARDS, the most deadly symptoms associated with COVID-19, this teatment has the potential to meet a dire need in the medical community.
Considering all factors, HGEN is stock that’s hard to ignore.
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