The oncology-focused biopharmaceutical company Veru ( NASDAQ: VERU ) has added ~11% in the pre-market Thursday after Jefferies argued that late-stage results for the company’s oral COVID therapy sabizabulin could warrant an emergency use nod from the FDA.
Veru ( VERU ) climbed 13% on Wednesday after the company said that Phase 3 results for the anti-viral and anti-inflammatory drug candidate published in the New England Journal of Medicine.
The results indicated that the 204-subject trial achieved primary endpoint as sabizabulin led to about 55% relative reduction in mortality compared to placebo in moderate-severe hospitalized COVID-19 patients at Day 60.
According to Jefferies analyst Chris Howerton the results “likely portends” FDA’s emergency use authorization for in about 30 days. Despite recent investor skepticism, the published data addressed most concerns.
However, Dr. Ilan Schwartz, an infectious disease expert at the University of Alberta noted that the trial was relatively small.
“Overall, I think this is very exciting, although I would welcome larger and independent confirmatory studies,” The New York Times quoted Dr. Schwartz as saying.
However, Dr. Schwartz who was not involved in the study cheered the results. “We have a small number of treatments for patients with severe disease that improve mortality, but another treatment that can further reduce deaths would be very welcome.”
In terms of current analyst ratings, Veru ( VERU ) commands a Strong Buy recommendation on Wall Street.
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Veru up 11% as Jefferies predicts emergency nod for COVID therapy