Veru (NASDAQ:VERU) stock is rising higher on Wednesday following a recent ruling from the U.S. Food and Drug Administration (FDA) on its Covid-19 treatment.
According to a Veru press release, the FDA has agreed to allow the company to submit its sabizabulin Covid-19 drug for Emergency Use Authorization (EUA). This decision was based on study results for its use in “hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome.”
The FDA agreed that the results from the company’s Phase 3 COVID-19 study were sufficient for it to submit a EUA. This comes after the Independent Data Monitoring Committee stopped the study early due to “overwhelming efficacy.”
Veru is already prepared for approval after scaling up its manufacturing capabilities. This will allow it to handle commercialization in the U.S., as well as other regions where approval is pending. It’s also initiated talks with the U.S., and other governments, for orders of its Covid-19 treatment.
Mitchell Steiner, M.D., chairman, president and CEO of Veru, said the following in the news release boosting the company’s stock higher today.
“The discussion with FDA in the Pre-EUA meeting has established a direct path forward to expedite the availability of sabizabulin to the high risk hospitalized patients with COVID-19.”
Veru expects to submit its EUA application to the FDA in the second quarter of 2022.
It’s also worth noting that VERU stock is experiencing heavy trading on today’s news. This has some 22 million shares on the move. For the record, the company’s daily average trading volume is around 18.7 million shares.
VERU stock is up 8% as of Wednesday morning.
There’s more recent stock market news for traders to dive into below!
InvestorPlace has all the hottest stock new for Wednesday in one place! Among that is what’s happening with Redbox (NASDAQ:RDBX) stock, this morning’s pre-market stock movers, as well as tech stocks to consider for a rebound. You can find all of that news at the following links!
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On the date of publication, William White 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.
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