What happened
Shares of Veru (VERU +0.45%) were up by more than 20.6% as of 10:06 a.m. ET Wednesday following the publication of overwhelmingly positive results from a phase 3 clinical trial of the biotech's drug candidate sabizabulin as a treatment for people hospitalized with severe cases of COVID-19.
The results, published in the prestigious New England Journal of Medicine, indicate that patients treated with sabizabulin rather than a placebo experienced a 55.2% relative reduction in mortality, a 26% relative reduction in days spent in the hospital, and a 43% relative reduction in days spent in the intensive care unit. Furthermore, the medicine's side effect profile was found to be adequate, affirming the results from prior clinical trials.
NASDAQ: VERU
Key Data Points
So what
The data mean that Veru's chances of commercializing sabizabulin are quite high, which is important, as the company is also investigating it in a trio of other late-stage clinical trials for indications in certain types of metastatic breast cancer and metastatic treatment-resistant prostate cancer.
While Veru has commercialized some reproductive health products, those have not been lucrative enough to make the biotech consistently profitable. Getting sabizabulin to the market for an indication like severe COVID-19 would likely be enough to change that.
Now what
Veru has already sent its data packet to the Food and Drug Administration (FDA) in hopes of securing an Emergency Use Authorization (EUA) for sabizabulin, which would enable it to rapidly commercialize the drug. It's probable that its stock will get another big boost if the FDA approves the EUA application, which management contends could occur as soon as this month.
