Shares of Veru (NASDAQ: VERU) tanked more than 60% in pre-market trading on Thursday after the advisory committee meeting at the U.S. FDA voted against granting the emergency use authorization (EUA) for its oral COVID-19 therapy sabizabulin.
While the FDA review team did acknowledge that “Study 902 met its prespecified primary endpoint of all-cause mortality at Day 60”, the review committee did point out that “the VERU-111 program is quite small in size compared to other therapeutic programs for patients hospitalized with COVID-19.”
The FDA team also pointed out “a number of uncertainties with the data.”
Veru stated in a press release following the advisory team report that “there was additional discussion around the clinical trial design aspects of an additional clinical trial as a potential post authorization requirement.”
