Veru Stock Price, News & Analysis

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.

Veru Inc. (NASDAQ: VERU) has appointed Jason Davies as the new Executive Vice President – General Manager overseeing EMEA, LATAM, and APAC for its Infectious Disease Franchise. Davies brings extensive experience from Janssen, where he led launch strategies across EMEA. This role is critical as Veru aims to enhance its international strategies and market potential for sabizabulin, a treatment for COVID-19. The company also reported positive results from its Phase 3 COVID-19 study, showing a 55.2% reduction in deaths among treated patients, with ongoing efforts for FDA emergency use authorization.

Veru Inc. (NASDAQ: VERU) announced inducement awards for five new employees, granting stock options for 128,450 shares under its 2022 Employment Inducement Equity Incentive Plan. The awards are a material inducement for the employees' entry into the company. Veru is focused on developing treatments for COVID-19, cancers, and ARDS-related diseases. The company has reported significant results in its Phase 3 COVID-19 study, showing a 55.2% reduction in deaths among treated patients. The study was halted for efficacy, and an emergency use authorization has been requested from the FDA.

Veru Inc. (NASDAQ: VERU) reported a 46% decline in total net revenues to $9.6 million for Q3 FY2022, with US FC2 prescription revenues dropping 50% to $6.7 million. Gross profit also decreased by 49% to $7.1 million. Research and development expenses surged to $18.1 million, leading to an operating loss of $21.8 million and a net loss of $22.2 million ($0.28/share). Despite these challenges, Veru is advancing its COVID-19 treatment Sabizabulin, which has shown promising Phase 3 trial results, and aims for commercial launches pending FDA emergency authorizations.

Veru Inc. (NASDAQ: VERU) announced positive Phase 3 results for its COVID-19 treatment, Sabizabulin, presented at the International Conference on Emerging Infectious Diseases on August 8, 2022. The study demonstrated a statistically significant 55.2% reduction in mortality among hospitalized patients at high risk for Acute Respiratory Distress Syndrome (ARDS). Furthermore, Sabizabulin showed significant reductions in ICU stays, mechanical ventilation days, and overall hospital duration. The company is pursuing emergency authorization from various regulatory bodies to expedite Sabizabulin's availability.

Veru Inc. (NASDAQ: VERU) will announce its fiscal 2022 third-quarter financial results on August 11, 2022, before market opening. A conference call will follow at 8 a.m. ET to discuss performance. The company is known for developing treatments for COVID-19 and cancer. Veru has reported positive results from a Phase 3 COVID-19 study, showing a 55.2% reduction in deaths among treated patients. The company also continues to progress in clinical trials for various cancers, including two FDA-designated studies.

Veru Inc. (NASDAQ: VERU) has announced that the European Medicines Agency (EMA) Emergency Task Force has initiated a review of its drug, sabizabulin, for treating hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). This review will assess data from a clinical trial showing a 55.2% reduction in deaths among treated patients compared to a placebo. With rising COVID-19 cases in Europe, there is potential for sabizabulin to become available to EU member states before formal approval, pending positive recommendations from the EMA.