Oppenheimer analyst Leland Gershell maintains Veru, Inc. at Outperform with a price target of $36.00, following a recent FDA AdComm vote.
(from a post on yhoo)
Veru (VERU): "See EUA More Likely Than Not " - Oppenheimer Reiterates Stock at Outperform, $36 PT, November 10, 2022 6:30 AM EST
The analyst comments: "At face value, yesterday's advisory committee vote of 5 yes, 8 no to the single voting question of whether sabizabulin's benefits outweigh its risks in those hospitalized with COVID-19 at high risk of ARDS may be taken by some as fait accompli that the FDA will deny VERU's EUA request. Irrespective of their individual votes, all the panel members were favorable on the drug's potential utility and expressed appreciation for the considerably limited amount of efficacy, safety, and mechanistic understanding on sabizabulin, as well as the potential for various aspects of the Phase 3 trial to have biased its outcome. We believe the key distinction between those who voted "yes" vs. "no" was the standard against which this unique case was measured—a standard that may have been unreasonably stringent in the minds of the "no" voters, as the Phase 3 was conducted during a critical/chaotic period of the pandemic in which more ideal trial conditions simply may not have existed.
We believe the most reasonable course of regulatory action will be that which the briefing documents appeared to lay out, that is, for the FDA to authorize sabizabulin for emergency use in the Phase 3 population (WHO 5 and 6, or WHO 4 with comorbidities) and, as a condition of such, stipulate that VERU conduct another randomized double-blind trial in the same population in which patients are fully matched with respect to baseline characteristics and evaluates sabizabulin for superiority to placebo on top of standard of care."
