Veru, Inc. (VERU) Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin

FREE Breaking News Alerts from StreetInsider.com!

E-mail Address

StreetInsider.com Top Tickers, 10/28/2026

1. ORCL
2. AVGO
3. BA
4. CDNS
5. ANT
6. SPY
7. META
8. HOOD
9. STX
10. INTC

Go back to Veru, Inc. (VERU) Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin

Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin Treatment of Hospitalized COVID-19 Adult Patients at High Risk for ARDS

May 4, 2023 8:30 AM EDT

Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60

Study to expand treatment population to include all WHO-4, WHO-5, and WHO-6 hospitalized adult COVID-19 patients at high risk for ARDS regardless of the presence of comorbidities

Two interim efficacy analyses are planned; study may be stopped if statistical criteria are met for efficacy

If confirmatory Phase 3 clinical trial meets statistical... More