Veru Stock Price, News & Analysis

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.

Veru Inc. (NASDAQ: VERU) announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) supports an expedited review of its marketing authorization application for sabizabulin, a treatment for hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). Veru plans to submit the application soon, emphasizing the urgency due to rising COVID-19 cases and high mortality rates. The company previously conducted a successful Phase 3 COVID-19 study, showing a 55.2% reduction in deaths among treated patients.

Veru Inc. (NASDAQ: VERU) announced the granting of inducement awards to three new employees under its 2022 Employment Inducement Equity Incentive Plan. A total of 94,450 stock options were awarded, vesting over three years. The company is focused on developing treatments for COVID-19, breast cancer, and prostate cancer. Notably, a Phase 3 trial for sabizabulin showed a 55.2% reduction in deaths among hospitalized COVID-19 patients, leading to a request for FDA emergency use authorization.

Veru Inc. has announced successful results from its Phase 3 clinical trial of sabizabulin for hospitalized COVID-19 patients. The treatment demonstrated a statistically significant 55.2% reduction in mortality compared to placebo. Key secondary endpoints showed notable reductions in ICU days, mechanical ventilation days, and hospital stays. The safety profile of sabizabulin was favorable, with fewer adverse events than the placebo group. Following these results, the company has requested Emergency Use Authorization from the FDA, positioning sabizabulin as a potential critical treatment in the ongoing fight against COVID-19.

On June 24, 2022, Veru Inc. (NASDAQ: VERU), a biopharmaceutical firm focused on developing COVID-19 treatments and cancer therapies, announced the granting of inducement stock options to three new employees. A total of 90,000 shares were awarded under the 2022 Employment Inducement Equity Incentive Plan, vesting in three annual installments. In clinical updates, a Phase 3 COVID-19 trial showed sabizabulin reduced mortality by 55.2%, prompting a request for FDA emergency use authorization. Veru also advanced its breast and prostate cancer drug portfolio with ongoing studies.

Veru Inc. has submitted an Emergency Use Authorization (EUA) application to the FDA for sabizabulin, a novel oral treatment for hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). The submission follows promising Phase 3 trial results indicating a 55.2% reduction in mortality among patients using sabizabulin. Discussions for EUA are ongoing with global regulatory bodies. The company is also scaling up manufacturing in anticipation of a U.S. commercial launch upon approval.

Veru Inc. (NASDAQ: VERU) announced the final results of its Phase 1b/2 clinical study of sabizabulin for metastatic castration-resistant prostate cancer (mCRPC). The study involved 80 men and showcased a median radiographic progression-free survival of 11.4 months, significantly exceeding the typical 3-4 months benchmark for existing treatments. Sabizabulin was well tolerated with no major safety concerns. The Phase 3 VERACITY study is currently enrolling patients, with completion expected by the end of 2022, alongside ongoing COVID-19 trials.