Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company focused on breast and prostate cancer, posted overwhelming results from the interim analysis of Phase 3 COVID-19 clinical trial of the oral vaccine candidate, sabizabulin 9 mg, versus placebo. Based on the promising efficacy reflected by the trial, the Independent Data Safety Monitoring Committee halted the Phase 3 study early, with no new safety concerns identified.
Following the update, shares of the company skyrocketed 182.3% at yesterday’s close, and further rose 13.36% in the extended trading session.
The analysis included 150 hospitalized COVID-19 patients, who were at high risk for Acute Respiratory Distress Syndrome (ARDS).
Supporting Data
The Phase 3 COVID-19 study was designed to evaluate the oral dose of sabizabulin 9 mg, once daily, versus placebo in about 210 patients. These patients included individuals who were infected by the Delta and Omicron variants of COVID-19 and were hospitalized due to moderate to severe conditions. Also, they had a high risk for ARDS and death and the primary endpoint was death at or before day 60.
The trial took place in the United States, Brazil, Colombia, Argentina, Mexico, and Bulgaria.
Further, an interim analysis was conducted, which included the first 150 patients who participated in the study. According to the analysis, the sabizabulin treatment resulted in a “clinically and statistically meaningful 55% relative reduction in deaths.” Additionally, the study reflected a well-tolerated safety profile.
CEO’s Comments
On reaching the milestone, Veru CEO Mitchell Steiner said, “We strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties which demonstrated positive efficacy and safety results in the Phase 3 COVID-19 study, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients.”
Regulatory Approvals
Following the positive update, Veru now plans to submit an application for Emergency Use Authorization (EUA) of sabizabulin with the U.S. Food and Drug Administration (FDA). Remarkably, in January 2022, the clinical program was awarded the Fast Track designation by the FDA.
On obtaining the FDA authorization, the company plans to meticulously produce commercial drug supply to meet expected requirements.
Also, for obtaining an advance purchase agreement of the drug for the U.S., Veru is under discussion with BARDA and other U.S. government agencies.
Wall Street’s Take
Following promising results and the company’s favorable risk-reward profile, Brookline Capital Markets analyst Kumaraguru Raja maintained a Buy rating and a price target of $29 (136.16% upside potential) on Veru.
Shares of Veru have rallied 25.82% over the past year, while the stock still scores a Strong Buy consensus rating, based on three unanimous Buys. That’s alongside an average Veru price target of $25, which implies 103.58% upside potential to current levels.
Risk Analysis
According to the new TipRanks Risk Factors tool, Veru stock is at risk mainly from three factors: Finance and Corporate, Tech and Innovation, and Legal and Regulatory, which contribute 16, 12, and 11 risks, respectively, to the total 59 risks identified for the stock.
Bottom Line
Given the company’s strong pharmaceutical results, high analyst ratings, decent risk profile, and current stock movements, investors might consider investing in this stock.
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