Pharmaceutical firm Veru (NASDAQ:VERU) kicked off the first complete week of November with a bang as it delivered overall positive results regarding its Covid-19 therapeutic sabizabulin. Targeting the treatment of Covid-19 for hospitalized patients at high risk of acute respiratory distress syndrome (ARDS), sabizabulin demonstrated effectiveness at reducing the death rate in a late-stage trial. As a result, VERU stock popped up 40% despite some uncertainty over the data.
According to a Reuters report, the U.S. Food and Drug Administration (FDA) mentioned that its staff reviewers “said the data did not help in clearly identifying a relevant patient population and remained unclear about the mortality rate in the placebo group.”
Per the FDA’s briefing document related to Veru’s request for emergency use authorization, VERU-111 (sabizabulin), “is a new molecular entity (NME), that is not approved for any indication. Prior to being developed for COVID-19, it was being studied in castration-resistant prostate cancer. It is proposed as a microtubule inhibitor, but it’s [sic] mechanism of action in COVID-19 is uncertain.”
Notably, the FDA declared that “the available clinical information for VERU-111 is limited when compared to the typical efficacy and safety databases available for other products that have been granted EUA.”
Still, optimism rang out for VERU stock as the FDA’s review team also stated that the underlying clinical study “met its prespecified primary endpoint of all-cause mortality at Day 60.”
Momentum Continues for VERU Stock
Aside from Monday’s 40% moonshot, VERU stock has been a rare investment in 2022, giving its stakeholders reason to smile. Since the start of the year, shares gained a blistering 132%. For comparison’s sake, the benchmark S&P 500 index fell 21% during the same period.
To be fair, circumstances did not look auspicious for VERU stock for most of the first half of this year. Shares actually traded in negative territory until April 11. That was when an independent data monitoring committee recommended that the Phase 3 trial for sabizabulin be stopped early due to overwhelming evidence of efficacy.
At the time, a report published on Biospace mentioned that sabizabulin showed a statistically significant and clinically meaningful 55% reduction in deaths compared to placebo in moderate-severe hospitalized patients.
Therefore, investors are likely optimistic that the pharmaceutical firm will win EUA approval, which will be discussed later this week.
On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.