Veru COVID respiratory treatment sabizabulin declined authorization by FDA; down 26%

Mar. 02, 2023 5:00 PM ETVeru Inc. (VERU)By: Jonathan Block, SA News Editor8 Comments

The US FDA has declined to authorize sabizabulin, Veru's (NASDAQ:VERU) treatment for hospitalized adults with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome .
Shares are down 26% in after-hours trading.
The agency also addressed a potential phase 3 study protocol that could support a new Emergency Use Authorization (EUA) application or a New Drug Application.
The FDA told the company "strong consideration should be given to appropriate time frames for interim analyses so that – should a strong efficacy signal again be observed – the trial could be stopped in an efficient time frame."
Veru (VERU) CEO Mitchell Steiner said the EUA request was denied "because of the possibility of unknown influences, or uncertainties that may have affected the study as FDA agreed upon its review that our Phase 3 study met its primary endpoint and could not be invalidated by any known influences."
Read why Seeking Alpha contributor Ramkumar Raja Chidambaram recently issued a sell rating for Veru (VERU).