VERU - Veru spikes as FDA agrees to discuss plans for oral COVID-19 therapy

2023-04-04 09:17:24 ET

Veru ( NASDAQ: VERU ) shares added ~7% pre-market Tuesday after disclosing that the FDA has granted a meeting to discuss a Phase 3 confirmatory study for sabizabulin, the company’s experimental COVID-19 therapy.

In early March, the FDA declined to authorize sabizabulin for emergency use to treat hospitalized adults with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS).

However, the company said it would continue to work with the regulator on plans to advance sabizabulin towards a new emergency use authorization and/or NDA approval in a potential Phase 3 confirmatory study.

Announcing pre-clinical data to support the oral drug on Tuesday, Veru ( VERU ) said that the FDA granted an “expedited meeting” this month to finalize a clinical trial design and discuss requirements for a EUA submission and new drug application for sabizabulin.

The company plans to run a placebo-controlled randomized Phase 3 study for the microtubule disruptor to study its effects on hospitalized influenza patients at high risk for ARDS.

As for pre-clinical data, the company said that in contrast to the anti-inflammatory agent dexamethasone, sabizabulin led to a statistically significant decrease in inflammatory cells in the lungs of an influenza-induced pulmonary inflammation mouse ARDS model.

Read: Despite the recent FDA snub, Seeking Alpha author Terry Chrisomalis reaffirmed his Strong Buy on VERU, citing potential EUA decisions favoring sabizabulin overseas.

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