Veru stock skyrocketed Monday after the Food and Drug Administration posted a mixed review of its repurposed cancer drug for Covid treatment.
The FDA briefing documents come ahead of an advisory committee meeting set for Wednesday.
A panel of independent experts will decide whether the benefits of Veru's drug, dubbed VERU-111, outweigh its risks in some Covid patients. The agency isn't bound by the panel's vote, though it takes it under consideration.
On the stock market today, Veru stock catapulted 39.5% to 14.44. Earlier, shares soared nearly 54%.
Veru Stock: Small Study Size
Veru is testing its drug in patients with forms of breast and prostate cancer.
But it also believes the same drug could help hospitalized patients with moderate to severe Covid who are also at heightened risk of acute respiratory distress syndrome, or ARDS. ARDS is a life-threatening condition in which the lungs can't provide the body's vital organs with enough oxygen.
In briefing documents ahead of the advisory committee meeting, the FDA reviewer acknowledged Veru met the goals of its study. Fewer patients who received VERU-111 died in the study. The results were so successful that independent experts said Veru could stop the study early. The news sent Veru stock close to a record high in August.
But the study was small, involving just 150 patients. Veru had enrolled an additional 54 patients at that point. They were allowed to finish the study. Still, the FDA said Veru would need at least 300 patients to show a statistically significant result.
It's important to note, Veru is asking for an emergency use authorization rather than a full approval for VERU-111 in Covid patients.
Shares Surge To A Recent High
Still, Veru stock surged to a two-month high Monday.
Shares have a strong Relative Strength Rating of 94 out of a best-possible 99. This means Veru stock ranks in the leading 6% of all stocks in terms of 12-month performance, according to IBD Digital.
The move Monday also sent Veru stock above its 50-day moving average for the first time since September, MarketSmith.com shows.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.