Veru Inc. (NASDAQ: VERU) stock price increased after the US Food and Drug Administration agreed that the biopharmaceutical company’s COVID-19 treatment could be submitted for an Emergency Use Authorization request.
VERU was worth $9.67 at the time of writing, representing a 24% gain. Veru’s stock has risen 32.3% year to date, while the S&P 500 SPX, +0.25%, has fallen 16.1%.
According to the company, the FDA agreement was based on efficacy and safety data from a completed Phase 3 trial of the company’s sabizabulin treatment for hospitalized COVID-19 patients at high risk of an acute respiratory disease syndrome.
Furthermore, the FDA has agreed that the current safety data for sabizabulin is sufficient to support the safety portion of a EUA submission request. The FDA informed the company that additional safety data collected during the use of sabizabulin under the EUA, if granted, would be sufficient to support an NDA submission and that no additional safety clinical studies would be required.
Veru plans to submit a EUA application request 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. 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.” Chief Executive Mitchell Steiner
Veru is a biopharmaceutical company focused on developing novel treatments for COVID-19 and other viral and ARDS-related diseases and breast and prostate cancer management.