Veru Stock Price, News & Analysis

Veru Inc. (NASDAQ: VERU) has appointed David D. Ho, M.D., as the Chairman of its Scientific Advisory Board (SAB). Dr. Ho, a renowned expert in infectious disease research, will help drive the clinical development of Veru’s infectious disease program, particularly focusing on sabizabulin, a new treatment for COVID-19. Earlier studies showed that sabizabulin reduced mortality by 55.2% in high-risk patients. Dr. Ho's expertise is expected to bolster Veru's efforts in bringing innovative therapies to market for COVID-19 and other viral diseases.

Veru Inc. (NASDAQ: VERU) announced that the U.S. FDA is reviewing its Emergency Use Authorization (EUA) application for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS. The company reported a net loss of $83.8 million for fiscal 2022, with total revenues decreasing to $39.4 million from $61.3 million in 2021. Despite a decline in FC2 revenue due to challenges with telemedicine customers, Veru is preparing for commercialization of sabizabulin. The company also highlighted ongoing clinical trials for various cancer treatments, including enobosarm and sabizabulin.

Veru Inc. (NASDAQ: VERU) will host a conference call on December 5, 2022, at 8:00 a.m. ET to discuss its fiscal 2022 fourth quarter and full year financial results. The company focuses on developing treatments for COVID-19 and oncology. The Phase 3 study of sabizabulin, an oral treatment for severe COVID-19, demonstrated a 55.2% reduction in mortality compared to placebo. Veru is also advancing its oncology programs, including enobosarm for breast cancer and its prostate cancer portfolio.

Veru Inc. (NASDAQ: VERU) reported the results of the FDA’s Pulmonary-Allergy Drugs Advisory Committee meeting regarding sabizabulin for Emergency Use Authorization (EUA) in hospitalized COVID-19 patients at high risk for ARDS. The committee voted 8-5 against the use of sabizabulin, citing that its benefits do not outweigh risks. A Phase 3 trial showed a 20.5% absolute reduction in mortality at 60 days among treated patients. Veru aims to collaborate with the FDA on further clinical trials while navigating the regulatory landscape for sabizabulin in the ongoing COVID-19 crisis.

Veru Inc. (NASDAQ: VERU) announced promising results from a Phase 3 trial of sabizabulin for hospitalized COVID-19 patients requiring supplemental oxygen. Presented at IDWeek 2022, findings indicated a 55.2% relative reduction in mortality and significant decreases in ICU stays and mechanical ventilation days. In patients with comorbidities, there was an 81.2% relative reduction in deaths. Sabizabulin showed good tolerability, and the trial's success has led to plans for emergency use authorization discussions with the FDA.

Veru Inc. (NASDAQ: VERU) announced that data from its Phase 3 trial of sabizabulin for hospitalized COVID-19 patients requiring supplemental oxygen will be presented at IDWeek 2022, occurring from October 19-23 in Washington, D.C. The late-breaking presentation, titled 'Clinical Benefit of Oral sabizabulin for Hospitalized Adults with COVID-19 on Supplemental Oxygen', is scheduled for October 21, 2022. The trial shows sabizabulin resulted in a 55.2% relative reduction in deaths compared to placebo, leading to a request for Emergency Use Authorization from the FDA.

Veru Inc. (NASDAQ: VERU) announced inducement awards for seven new employees as part of their employment agreement, complying with NASDAQ Listing Rule 5635(c)(4). The stock options granted amount to a total of 99,150 shares, vesting in three annual installments. The company is advancing its infectious disease and oncology programs, reporting positive Phase 3 study results for sabizabulin in COVID-19 patients, showing a 55.2% reduction in deaths. Veru is also engaged in multiple ongoing clinical trials for breast and prostate cancers, aiming for regulatory approvals and market access.

Veru Inc. (NASDAQ: VERU) announced its participation in the Cantor Oncology, Hematology, HemeOnc Conference on September 28, 2022, in New York City. The biopharmaceutical company is focused on developing treatments for COVID-19 and cancers. A recent Phase 3 study of sabizabulin showed a significant 55.2% reduction in deaths among hospitalized COVID-19 patients. The FDA is set to discuss emergency use authorization for sabizabulin on November 9, 2022. The company also has ongoing studies for its oncology portfolio, including enobosarm for breast cancer.

Veru Inc. (NASDAQ: VERU) announced that the FDA has rescheduled the advisory committee meeting regarding Emergency Use Authorization for sabizabulin in COVID-19 patients at high risk for ARDS to November 09, 2022. The agenda remains unchanged. A positive Phase 3 study of sabizabulin in hospitalized COVID-19 patients showed a statistically significant 55.2% reduction in deaths compared to placebo. Additionally, the Company is progressing with late-stage studies for breast and prostate cancer treatments, including enobosarm and sabizabulin.