Humanigen (NASDAQ: HGEN) shares have plunged over 50% premarket after the FDA declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients.
According to Humanigen, the FDA stated in its letter that it could not conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19.
The company said the FDA has committed to working with Humanigen to develop lenzilumab and has invited it to submit additional data as it becomes available.
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“We remain committed to bringing lenzilumab to patients hospitalized with COVID-19,” said Cameron Durrant, CEO of Humanigen.
“We believe the ongoing ACTIV-5/BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an EUA to treat hospitalized COVID-19 patients.”
Humanigen shares are trading at $6.96 premarket, down 53.94%. Its stock price is down 13.66% so far this year.
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