What happened
Shares of Veru (VERU -7.75%) surged 16.8% on Tuesday, after the biopharmaceutical company submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its novel coronavirus oral drug candidate, sabizabulin.
So what
Sabizabulin is a once-daily antiviral and anti-inflammatory treatment for hospitalized patients with moderate to severe COVID-19, who are at high risk of acute respiratory distress syndrome. ARDS is an often-fatal condition that makes it difficult for people to breathe without a ventilator.
"COVID-19 new cases and hospitalizations are on the rise again with a summer and fall-winter peaks expected," Veru CEO Mitchell Steiner said in a press release. "Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 who are at risk for ARDS remains and will continue to be unacceptably high with current standard of care."
Image source: Getty Images.
In April, Veru announced promising results from a phase 3 study that showed sabizabulin reduced deaths in hospitalized patients with moderate to severe COVID-19 by 55%. The trial was halted because of the overwhelming efficacy of the drug.
"By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19," Steiner said. "We are moving as quickly as possible to get this potential treatment to patients by expeditiously submitting this request for EUA application."
Now what
As it awaits the FDA's decision, Veru is ramping up its drug production capabilities. The company also intends to request emergency authorization for sabizabulin from international regulatory agencies.
If Veru is granted EUA from the FDA and other healthcare regulators, demand for its new COVID-19 treatment could be strong. And sales of the drug could drive its share price significantly higher in the weeks and months ahead.
