Welcome to our dedicated page for Veru news (Ticker: VERU), a resource for investors and traders seeking the latest updates and insights on Veru stock.
Veru Inc. develops late clinical-stage biopharmaceutical programs for cardiometabolic and inflammatory diseases. Company news centers on clinical development of enobosarm, an oral selective androgen receptor modulator being studied with GLP-1 receptor agonist therapy to make weight reduction more selective for fat loss while preserving lean mass, physical function, and bone.
Recurring updates also cover sabizabulin, an oral microtubule disruptor being developed for chronic inflammation related to atherosclerotic cardiovascular disease. Veru’s announcements commonly include fiscal results, business updates, clinical-study progress, regulatory feedback, scientific presentations, and conference webcasts tied to its small-molecule pipeline.
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.
Veru Inc. (NASDAQ: VERU) announced that the FDA will hold a meeting on October 6, 2022, to discuss the Emergency Use Authorization for sabizabulin as a treatment for hospitalized COVID-19 patients at high risk for ARDS. The FDA completed audits of clinical sites without reporting deficiencies. A Phase 3 trial demonstrated a 55.2% reduction in deaths for patients treated with sabizabulin compared to placebo, prompting the request for authorization. The company is also engaged in late-stage development for breast and prostate cancer treatment options.
Veru Inc. (NASDAQ: VERU) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 7:00 AM EDT. The company focuses on developing medicines for COVID-19, other viral diseases, and cancer treatments. They completed a Phase 3 COVID-19 study for sabizabulin, showing a 55.2% reduction in deaths for treated patients. Veru submitted a request for emergency use authorization for sabizabulin, with ongoing studies for enobosarm in breast cancer and ongoing trials for prostate cancer treatments.
On August 22, 2022, Veru announced that Australia’s TGA approved an expedited regulatory pathway for sabizabulin, designed for hospitalized COVID-19 patients at high risk of Acute Respiratory Distress Syndrome (ARDS). This provisional registration allows for quicker access to treatment in Australia. Veru's sabizabulin showed a statistically significant 55.2% reduction in deaths during a Phase 3 trial, prompting the company to pursue similar approvals from the FDA, EMA, and MHRA. The company is also advancing its oncology programs for breast and prostate cancer treatments.