Business
Veru Reports Fiscal 2022 Fourth Quarter and Full Year Financial Results
U.S. FDA reviewing EUA application for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS European Medicines Agency’s (EMA) Emergency
About this update from Veru Inc.
[{"type":"text","content":"U.S. FDA reviewing EUA application for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS European Medicines Agency’s (EMA) Emergency Task Force reviewing sabizabulin for emergency use in EU member states Sabizabulin also under review for potential emergency authorization by MHRA (UK), TGA (Australia), and Health Canada Veru preparing for U.S. and international commercialization and distribution of sabizabulin, and manufacturing capacity for drug supply in place Company to host conference call and webcast today at 8:00 a.m. ET MIAMI, FL, Dec. 05, 2022 (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 2022 fourth quarter and full year ended September 30, 2022 and provided a business update. “This has been a transformational year for Veru. We reported positive Phase 3 results demonstrating that sabizabulin treatment resulted in a statistically and clinically significant reduction in death in hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death, which was published in the NEJM Evidence®,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “As sabizabulin is being reviewed in the U.S. and internationally for potential emergency use authorization, we are preparing for commercialization and will be ready to deliver this treatment to patients, if authorized.” Dr. Steiner added, “While FC2 revenue decreased this past year due to business challenges experienced by our largest telemedicine customers, we are working diligently to regenerate FC2 product sales, and our recently launched telemedicine platform has shown steady market uptake to date.” Infectious Disease Program HighlightsSabizabulin: A Novel Oral, First-in-Class, Microtubule Disruptor for the Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)In November 2022, the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee met with the Company to review its request for Emergency Use Authorization (EUA) of sabizabulin. The Advisory Committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hos...