What happened
Shares of Veru (VERU 5.51%) were flying 31.6% higher at 12:14 p.m. ET on Thursday. The big gain came after the drugmaker provided its fiscal 2022 third-quarter update before the market opened.
Veru's Q3 results didn't appear to justify the sizable jump for the stock. The company reported total net revenue fell 46% year over year to $9.6 million. Its net loss totaled $22.2 million, or $0.28 per share. This result was much worse than the loss of $2.7 million, or $0.03 per share, in the prior-year period.
However, Veru's management sounded optimistic about the prospects of winning Emergency Use Authorization (EUA) for sabizabulin in treating hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). They also expect a revenue boost from the launch of Entadfi, which treats benign prostatic hyperplasia (enlarged prostate) with a low potential for adverse sexual side effects. This positive outlook appeared to be all investors needed to pile into the biotech stock.
So what
Veru filed for U.S. EUA for the experimental drug in June. The European Medicines Agency (EMA) is reviewing potential emergency use of sabizabulin in the European Union (EU) under a new emergency regulatory pathway. The United Kingdom is also expediting a review of the drug.
It's fair to say that sabizabulin could be a game changer for Veru if it's authorized. The White House has warned of a potential major coronavirus wave in the fall and winter. Sabizabulin holds the potential to prevent thousands of deaths.
Now what
U.S., EU, and U.K. authorization decisions for sabizabulin shouldn't take very long. Veru has cranked up its manufacturing capacity and expects to be able to produce enough doses to treat around 250,000 patients per month worldwide beginning in September.
