Veru said it hopes to have a ‘streamlined’ process of Emergency Use Authorization from the U.S. Food & Drug Administration for its oral Covid treatment.
Veru Inc. (VERU) – Get Veru Inc Report shares surged higher Tuesday following the drugmaker’s plans to seek Emergency Use Authorization from the U.S. Food & Drug Administration for its newly-developed Covid treatment.
Miami-based Veru said data from a late-stage study showed its new oral treatment, known as sabizabulin, provided a 55% reduction in deaths, when compared to a placebo, in hospitalized patients suffering from moderate-to-severe forms of Covid — irrespective of variant type. Sabizabulin was granted “fast track’ designation by the FDA in January, a move that Veru said could “streamline” its EUA process.
“We strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties which demonstrated positive efficacy and safety results in the Phase 3 COVID-19 study, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients,” said CEO Mitchell Steiner.
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Veru shares were marked 20.1% higher in pre-market trading to indicate an opening bell price of $14.79 each, a move that would value the group at just under $1.2 billion.
Oppenheimer analyst Leland Gershell, who carries an ‘outperform’ rating with a $36 price target on the stock, said FDA approval would provide Veru with a “substantial near-term revenue opportunity”.
Its demonstrated ability to improve outcomes in those at high risk of acute respiratory distress syndrome (ARDS) and death distinguishes sabizabulin from Mercks’s (MRK) – Get Merck & Co., Inc. Report Lagevrio and Pfizer’s (PFE) – Get Pfizer Inc. Report Paxlovid, indicated for milder disease and for which respective US government procurement contracts worth $2.2 billion and $5.3 billion have been awarded,” he said.
“With the global pandemic showing little sign of abating and (The Biomedical Advanced Research and Development Authority) to be allocated $9.25 billion in additional COVID-19 funding, we believe sabizabulin will serve critical roles in the US and abroad,” Gershell said.
