Veru (NASDAQ:VERU) stock is taking a beating on Friday after the U.S. Food and Drug Administration (FDA) denied the company’s request for an Emergency Use Authorization (EUA) for its Covid-19 treatment.
That rejection has to do with sabizabulin, which is Veru’s drug for treating patients in hospitals suffering from severe Covid-19. Specifically, the drug is meant for those at high risk of Acute Respiratory Distress Syndrome (ARDS).
Veru makes sure to point out that this rejection from the FDA is only specified “at this time.” The company says the government agency is still dedicated to working with Veru on the development of sabizabulin.
Mitchell Steiner, Chairman, President and CEO of Veru, said the following about the news:
“We are disappointed in the FDA’s decision to decline the request for an EUA because of the possibility of unknown influences, or uncertainties that may have affected the study as FDA agreed upon its review that our Phase 3 study met its primary endpoint and could not be invalidated by any known influences1, and we followed the unanimous recommendation of the Independent Data Monitoring Committee to stop the Phase 3 study because of clear clinical benefit.”
What This Means for VERU Stock
Without that EUA, Veru will be delayed in getting its Covid-related treatment to market. That could have a negative long-term effect on the stock as the company misses out on revenue that it was hoping for.
With this news, VERU stock is down 36.7% as of Friday morning.
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On the date of publication, William White did not hold (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.