Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, today announced positive efficacy and safety results from a planned interim analysis of the double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). The Independent Data Safety Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to efficacy, and they further remarked that no safety concerns were identified. In response to the aforementioned development, the VERU stock gained massively.
Highlights
- Independent Data Monitoring Committee Unanimously Recommends that Phase 3 Clinical Trial for Sabizabulin for Treatment of Hospitalized COVID-19 Patients at High Risk for ARDS Be Stopped Early Due to Overwhelming Evidence of Efficacy.
- Sabizabulin Treatment Showed Statistically Significant and Clinically Meaningful 55% Reduction in Deaths Compared to Placebo in Moderate-Severe Hospitalized Patients (p=0.0029).
- Sabizabulin Oral Daily Dosing was Well Tolerated with a Similar Safety Profile Compared to Placebo.
- Company to Meet with FDA to Seek Emergency Use Authorization.
- The Company Hosted a Conference Call at 8:00 am ET to Discuss Results and Planned Next Steps.
CEO’s Statement
“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.” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru
VERU stock
The VERU stock was up by a huge 45.06% and traded at $6.31 (up by 1.96 points) at 10:05 a.m. EDT in the market trading session today. The market capitalization of the stock stood at $504.29 million. Moreover, the share volume traded for the VERU stock was 34,912,324, skyrocketing from the average share volume of 906,481.
