Business
Veru Reports Fiscal 2023 First Quarter Financial Results
Sabizabulin for moderate to severe COVID-19 under review for potential emergency authorization by multiple global regulatory agencies Presented late-breaker
About this update from Veru Inc.
[{"type":"text","content":"Sabizabulin for moderate to severe COVID-19 under review for potential emergency authorization by multiple global regulatory agencies Presented late-breaker oral presentation at IDWeek; sabizabulin treatment resulted in 81.2% relative reduction in deaths compared to the placebo in the WHO 4 subset group Company to host conference call and webcast today at 8:00 a.m. ET MIAMI, FL, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2023 first quarter and provided a business update. “We have been busy seeking emergency authorization for sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for ARDS with major global regulatory bodies,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “Our U.S. and international commercial teams are on standby. We are actively enrolling subjects in our advanced breast and prostate cancer Phase 3 clinical studies. Further, we have put in place a multi-pronged strategy to increase revenues from our sexual health program which appears to be successful as Q2 FY 2023 sales are significantly improving. As we await regulatory decisions, we have implemented measures to prudently conserve our cash, and we will provide an update once we are able to determine our path forward.” Infectious Disease Program Updates Sabizabulin, a Novel Oral Microtubule Disruptor, for the Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) Sabizabulin for the treatment of COVID-19 is currently under regulatory review for potential emergency authorization by U.S. Food and Drug Administration (FDA), European Union’s European Medicines Agency (EMA), United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, South Korea’s Ministry of Food and Drug Safety (MFDS), and Switzerland’s Swissmedic. With respect to Europe, if the EMA authorizes sabizabulin for emergency use under Article 18, then individual EU nations may decide to authorize sabizabulin in their respective countries. In October 2022, Phase 3 data ...