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

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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