Veru, Inc. (NASDAQ: VERU) is engaged as an oncology-focused biopharmaceutical company, which specializes in novel treatments for breast and prostate cancers. Shares of the biopharma company are skyrocketing 203% through afternoon trading on Monday, April 11, 2022. Over the past three months, Veru has seen average daily volume of 1.08 million shares. However, volume of 206.67 million shares or dollar volume of around $2.62 billion, has already exchanged hands through early trading.
Shares of Veru are soaring after the company released strong positive efficacy and safety results from an interim analysis of its Phase 3 clinical trial of its novel COVID-19 drug versus a placebo. The trial included 150 COVID-19 patients that were hospitalized with high-risk for Acute Respiratory Distress Syndrome (ARDS).
The double-blind, randomized, placebo-controlled trial of the oral sabizabulin 9mg treatment featured a once-a-day dosing, compared to a placebo. Both groups were given access to standard of care treatments for COVID-19, such as remdesivir, dexamethasone, and more. Furthermore, the trial was conducted in the United States, Bulgaria, Brazil, Colombia, Argentina, and Mexico and featured both the Delta and Omicron variants of COVID-19.
The treatment group receiving the novel sabizabulin treatment resulted in a statistically significant 55% relative reduction in death compared to the placebo group. The placebo group had a mortality rate of 45%, compared to the sabizabulin-treat group, which had a mortality rate of 20%. The sabizabulin treat was well tolerated by patients, which saw no serious safety concerns or events.
The Phase 3 interim analysis results were so positive that the Independent Data Safety Monitoring Committee unanimously recommended the study be halted early due to efficacy. Veru is now planning a meeting with the U.S. Food and Drug Administration (FDA) to seek emergency use authorization for the sabizabulin oral treatment.
Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru: “This study represents a significant milestone in the global fight against COVID-19 as sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients with moderate to severe COVID-19. 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.”
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