FDA Staff Flags Uncertainties on Veru's COVID Drug; EUA Hopes Lift Shares

By Bhanvi Satija

November 08, 2022

(Reuters) - Staff reviewers at the U.S. Food and Drug Administration on Monday identified several uncertainties around Veru Inc's data for its experimental COVID-19 drug but did not raise any new concerns, sending its shares surging 52%.

The reviewers also did not offer any strong argument against the emergency use authorization (EUA) even as they flagged the small size of the trial that showed the drug reduced death rates, analysts said.

The data did not help clearly identify a relevant patient population and the high rate of deaths in a placebo group in the trial may raise questions about the results, the reviewers said.

"None of these uncertainties or imbalances alone invalidate the mortality benefit ... but all of these issues together in a small trial which is more vulnerable to imbalances raise questions about the results," the FDA said.

A panel of the health regulator's outside experts is scheduled to discuss authorization of the drug later this week, including whether additional data is required.

Cantor Fitzgerald analyst Brandon Folkes said the FDA is "leading the advisory committee towards granting an EUA" provided Veru commits to an adequate post-EUA study.

Veru has applied for an EUA for the drug, sabizabulin, as a treatment for hospitalized moderate-to-severe COVID-19 patients at high risk of developing an acute respiratory distress syndrome.

The application is based on a late-stage study of 210 patients that showed the drug helped in a 55.2% reduction in death rates versus placebo.

"Given that there was uncertainty heading into the recent documents, in terms of what the FDA would say, there is a bit of relief," said Leland Gershell, Oppenheimer analyst.

Veru's shares were up at $15.7 in afternoon trading. They fell nearly 9% since mid-September, when the FDA rescheduled the advisory committee meeting.

If authorized, sabizabulin, which Veru was originally testing as a treatment for prostate cancer, would become its second drug on the market.

(Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Shinjini Ganguli and Sriraj Kalluvila)

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