Veru Inc. ( VERU Quick Quote VERU - Free Report) gained 3.38% on Jul 7, marking the second consecutive rise following successful results from the late-stage study for COVID-19.
The increase is attributed to the publication of positive results from a phase III study evaluating the efficacy and safety of oral sabizabulin 9 mg versus placebo in approximately 210 hospitalized moderate to severe COVID-19 patients.
Sabizabulin is a novel dual antiviral and anti-inflammatory agent for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) and death.
The results were published in
The New England Journal of Medicine (NEJM) Evidence.
Patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo. Patients in both treatment groups were allowed to receive standard of care treatment, including
Gilead’s ( GILD Quick Quote GILD - Free Report) Veklury (remdesivir), dexamethasone, anti-IL6 receptor antibodies, and JAK inhibitors.
The study met primary and key secondary endpoints.
A planned interim analysis was conducted on the first 150 patients randomized into the study. The Independent Data Safety Monitoring Committee unanimously recommended that the phase III study be halted early due to clear efficacy benefit.
Treatment with sabizabulin showed a statistically significant and clinically meaningful 55.2% reduction in deaths compared to placebo in moderate to severe hospitalized COVID-19 patients, thereby achieving the primary endpoint.
Sabizabulin treatment had a significant and clinically meaningful reduction in days in ICU, days on mechanical ventilation and in the hospital, hence meeting the key secondary endpoints. The drug was well tolerated with a more favorable safety profile compared to placebo.
Shares of Veru surged 128.5% in the year so far against the
industry’s decline of 26.5%.
Image Source: Zacks Investment Research
Veru submitted a request for Emergency Use Authorization application to the FDA on Jun 7, 2022.
A potential authorization by the FDA will be a significant boost for Veru as new variants of COVID-19 emerge.
Veru has a vast and diverse portfolio focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
We note that the FDA approved a supplemental new drug application (sNDA) for Gilead’s Veklury for the treatment of pediatric patients who are older than 28 days, weighing at least three kgs. The patients are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death.
Veru currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks are
Sesen Bio ( SESN Quick Quote SESN - Free Report) and Geron Corporation ( GERN Quick Quote GERN - Free Report) . Sesen sports a Zacks Rank #1 (Strong Buy) and Geron carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Loss estimates for SESN for 2022 have narrowed to 44 cents from a loss of 46 cents in the past 60 days. Sesen surpassed estimates in all of the trailing four quarters, the average surprise being 69.94%.
Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.