FDA determined it couldn’t conclude that the benefits of lenzilumab from Humanigen (NSDQ:HGEN) outweigh the risks for patients hospitalized with COVID-19.
Lenzilumab is the company’s lead product candidate.
The drug works by neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF), which is implicated in the so-called cytokine storm.
The drug is the subject of 16 clinical trials spanning a range of diseases.
The Burlingame, California–based company had submitted EUA paperwork to the agency in May. Included in the filing were data from the LIVE-AIR Phase 3 clinical trial that evaluated the drug’s role in improving survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.
The company’s shares dropped 47.25% apiece to $7.97 following the announcement.
Analysts at H.C. Wainwright wrote in a brief note that the stock drop was an “overreaction,” but reduced their price target for the company from $36 to $28.
Humanigen is hoping the FDA’s decision is temporary. It plans on submitting additional data to the FDA from the NIH’s ACTIV-5/BET-B study. The company is aiming to obtain authorization to market the drug to treat hospitalized COVID-19 patients in the U.K. and elsewhere.
“We remain committed to bringing lenzilumab to patients hospitalized with COVID-19,” said Dr. Cameron Durrant, Humanigen CEO, in a statement.
In August, the company issued a press release indicating that lenzilumab may improve survival without ventilation in hospitalized Black and African American COVID-19 patients.