Jefferies Analyst Predicts FDA Emergency Use Nod For Veru COVID Therapy In 1 Month

 

• Despite recent investor skepticism, the Phase 3 COVID-19 results for Veru Inc's 
  VERU+3.38%+ Free Alerts
   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.
• 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.

https://www.benzinga.com/analyst-ratings/analyst-color/22/07/27991012/this-analyst-predicts-fda-emergency-use-nod-for-this-new-covid-19-therapy-in-a-mont