What happened
Shares of Veru (VERU 4.96%) were skyrocketing 40.7% higher at 11:17 a.m. ET on Monday. The huge gain came after the U.S. Food and Drug Administration (FDA) released a briefing document related to Veru's Emergency Use Authorization (EUA) request for the COVID-19 drug sabizabulin. The FDA's Pulmonary-Allergy Drugs Advisory Committee Meeting to review this EUA request is scheduled for Nov. 9, 2022.
So what
Today's jump adds to a strong year-to-date performance for Veru. The biotech stock had soared 76% before the FDA briefing document was released.
Some might focus on the FDA staff's concerns in the briefing document. For example, the agency pointed out the small size of Veru's clinical study evaluating sabizabulin. The FDA's review also identified "uncertainties with the data." These uncertainties included a high mortality rate in the study's placebo group and other questions about the study.
However, investors appear to have dismissed these concerns in light of the overall favorable tone of the briefing document. The FDA review team acknowledged that Veru's study met the primary endpoint with a mortality benefit at day 60. The briefing document also stated that none of the uncertainties invalidate this observed mortality benefit.
Now what
The recommendation from the Pulmonary-Allergy Drugs Advisory Committee Meeting will be known later this week. The FDA doesn't have to go along with the advisory committee's recommendation, though.
At this point, the chances of Veru winning EUA for sabizabulin appear to be pretty good. However, based on comments in the briefing document, the FDA will probably require Veru to conduct another clinical trial if the COVID-19 drug is authorized.
