Jefferies Analyst Predicts FDA Emergency Use Nod For Veru's New COVID-19 Therapy In One Month

Despite recent investor skepticism, the Phase 3 COVID-19 results for Veru Inc's VERU sabizabulin published in the New England Journal of Medicine "addressed most concerns," Jefferies writes.
The analyst sees the data as "further derisking" Veru's COVID opportunity and reiterates a Buy rating on the shares with a $55 price target.
The data likely signals an FDA Emergency Use Authorization in 30 days, Howerton contends.
Related: Veru Seeks FDA Emergency Use Nod For Its COVID-19 Treatment.
Patients enrolled are, in fact, sicker and support the higher mortality observed.
There was no meaningful impact of region on outcomes. The baseline demographics were well-balanced across arms, says the analyst.
Sabizabulin treatment showed a statistically significant and clinically meaningful 55.2% reduction in deaths compared to placebo in moderate-severe hospitalized COVID-19 patients.
The sabizabulin treatment had a significant and clinically meaningful reduction in days in ICU, mechanical ventilation, and the hospital.
Sabizabulin was well tolerated with a more favorable safety profile compared to placebo.
HC Wainwright notes that no current FDA-approved or authorized COVID-19 therapeutics in the hospital setting can achieve over 50% relative reduction in deaths.
Hence, sabizabulin can potentially become the new standard of care for hospitalized moderate-severe COVID-19 patients if its EUA application is granted.
Price Action: VERU shares are up 4.53% at $13.61 during the market session on the last check Thursday.

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