By Chris Wack


Veru Inc. shares were down 39% at $2.30 Friday after the company said late Thursday that the U.S. Food and Drug Administration declined to grant an emergency use authorization request for its Covid-19 drug candidate sabizabulin.

The stock hit its 52-week low of $2.26 earlier in the session and is down 58% over the past 12 months.

According to the Miami-based biopharmaceutical company, sabizabulin is a novel microtubule disruptor used to treat adult patients hospitalized with moderate to severe Covid-19 who are at a high risk of acute respiratory distress syndrome or death.

The FDA stated that despite having declined to issue an EUA for sabizabulin at this time, the agency remains committed to working with Veru in its efforts to develop sabizabulin.

The FDA also provided comments on Veru's proposed confirmatory Phase 3 study protocol to support a new EUA authorization or approval of a new drug application for the same indication of sabizabulin.

The FDA said that regarding the potential confirmatory Phase 3 clinical study design, "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 expects to communicate the details of the potential Phase 3 confirmatory study's design and timing soon.

The use of sabizabulin for treating hospitalized moderate to severe Covid-19 patients at high risk for ARDS is also currently under review for potential emergency authorization by regulatory agencies outside the U.S.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

03-03-23 1412ET