When Veru swiftly wrapped up a phase 3 trial of its COVID treatment last April, expectations bubbled that the company may be able to pry one more emergency use authorization from the FDA.
Those dreams were dashed Friday, after the company announced that regulators declined the EUA route for sabizabulin for now, recommending a confirmatory phase 3 trial instead. The company’s shares slid quickly on the news, down 38% in the first hours of trading from $3.78 to $2.35 per share.
It’s a disappointing ruling for Veru, which reported in April 2022 that its treatment reduced deaths among hospitalized patients with moderate to severe COVID at risk of acute respiratory distress syndrome by 55% compared to placebo. With that data in hand, the company ended its phase 3 trial early to ask regulators for authorization. The company’s share price more than doubled at the time to nearly $10.
Now, the FDA has at least made sure to hand Veru a participation trophy in the form of advice on a confirmatory trial. The company says regulators relayed that it should pay close attention to the time frame for an interim analysis, so that if a strong efficacy signal is once again seen, “the trial could be stopped in an efficient time frame.”