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Biotech / Medical : Female Health FHCO

VERU 2.965

-1.5%

Oct 31 9:30 AM EST

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From: Savant	5/13/2022 10:14:32 AM
	of 211

VERU U.S. Food and Drug Administration has agreed that the biopharmaceutical company's COVID-19 treatment can be submitted for a request for Emergency Use Authorization. The company said the FDA's agreement was based on efficacy and safety data from a completed Phase 3 trial of its sabizabulin treatment for hospitalized COVID-19 patients at high risk for acute respiratory disease syndrome. Veru expects to submit a request for an EUA application in the second quarter of 2022. "The discussion with FDA in the Pre-EUA meeting has established a direct path forward to expedite the availability of sabizabulin to the high risk hospitalized patients with COVID-19," said Chief Executive Mitchell Steiner. "In the Phase 3 COVID-19 clinical study, sabizabulin demonstrated a clear mortality benefit in hospitalized moderate to severe COVID-19 patients on current standard of care with no significant safety signals." Veru's stock has run up 32.3% year to date through Tuesday, while the S&P 500 has dropped 16.1%.

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