Why Veru (VERU) Stock Is Crashing Today - Veru (NASDAQ:VERU)

The FDA declined to grant Veru Inc's VERU request for Emergency Use Authorization (EUA) for sabizabulin to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS).
Separately, the FDA also commented on the company's proposed confirmatory Phase 3 study protocol for hospitalized moderate to severe COVID-19 patients at risk for ARDS and death that could support a new EUA authorization and/or NDA approval.
Also See: Biden Administration Plans To End COVID-19 Public Health Emergency In May.
FDA stated that in the potential confirmatory Phase 3 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 design and timing of this potential Phase 3 confirmatory study soon.
In May 2022, pre-EUA meeting with the FDA, the agency indicated that our clinical data package was sufficient to support a EUA submission.
In November, as per the briefing documents, the FDA had spelled out its concerns with the pivotal data that Veru submitted.
It acknowledged that sabizabulin hit the mark on mortality in the small trial but noted uncertainties or imbalances that, while not problematic individually, "raise questions about the results."
Price Action: VERU shares are down 36.7% at $2.39 during the premarket session on the last check Friday.

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Why Veru Stock Is Crashing Today?