Veru Stock Price, News & Analysis

Veru Inc. (NASDAQ: VERU) announced participation in a fireside chat at the Jefferies Healthcare Conference on June 8, 2022, from 11:00 AM to 11:25 AM Eastern Time. The event will be accessible via webcast, and the archived version will be available for 30 days following the live session. Veru focuses on developing innovative treatments for COVID-19 and cancers, with promising clinical data showing a 55.2% reduction in deaths in COVID-19 patients during a Phase 3 trial. The company is preparing for an FDA emergency use authorization request for its drug, sabizabulin.

Veru Inc. (NASDAQ: VERU) announced the appointment of Joel Batten as Executive Vice President and Head of its U.S. Infectious Disease Franchise, effective May 23, 2022. Batten previously led the RSV Franchise at Sobi North America, generating approximately $600M in revenue. His extensive experience in commercial roles at AstraZeneca and Sanofi is expected to enhance Veru's strategies for their antiviral candidate, sabizabulin, currently under review for emergency use authorization by the FDA following positive Phase 3 trial results showing a 55.2% reduction in deaths among patients treated.

Veru Inc. (NASDAQ: VERU), a biopharmaceutical company, will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, from 11:30 AM to 12:00 PM EDT. The webcast will be accessible on their website following the presentation. Veru focuses on developing treatments for COVID-19 and cancers, notably through its investigational drug sabizabulin, which shows a 55.2% reduction in deaths from COVID-19 in a Phase 3 trial. The company also has clinical studies underway for its breast and prostate cancer therapies.

Veru Inc. announced significant developments regarding its COVID-19 treatment, sabizabulin, following a positive Phase 3 clinical study that showed a 55.2% reduction in mortality in hospitalized patients. The FDA has indicated that the company can proceed with an Emergency Use Authorization (EUA) request, which is expected to be submitted by Q2 2022. Financial results for Q2 2022 show a slight revenue decrease to $13.0 million, with an operating loss of $11.8 million. The company also reports progress on multiple cancer clinical trials and other drug development initiatives.

Veru Inc. (NASDAQ: VERU) announced that the FDA has agreed that no additional efficacy studies or safety data are required for Emergency Use Authorization (EUA) of its COVID-19 treatment, sabizabulin. A EUA application is planned for submission in Q2 2022. The Phase 3 study demonstrated a 55.2% reduction in mortality among hospitalized patients with COVID-19. The company has begun scaling up production and is in discussions for advance purchase agreements with government officials. A conference call is scheduled for May 12, 2022, to discuss FDA meeting outcomes and next steps.

On May 2, 2022, Veru Inc. (NASDAQ: VERU) announced that the FDA granted a pre-Emergency Use Authorization meeting set for May 10, 2022, following the positive results from a Phase 3 COVID-19 study on sabizabulin. The trial demonstrated a significant 55% reduction in death rates among hospitalized patients. The company aims to expedite the EUA process as COVID-19 cases rise. Veru is also advancing its breast cancer and prostate cancer drug portfolios, with multiple studies ongoing or planned, including collaborations with Eli Lilly.

Veru Inc. (NASDAQ: VERU) will announce its fiscal 2022 second quarter financial results on May 12, 2022, prior to market opening. A conference call is scheduled for the same day at 8 a.m. ET to discuss company performance and answer questions. The call will be accessible via phone and webcast. Veru is developing treatments for COVID-19 and cancers, with its COVID-19 candidate sabizabulin showing a 55% reduction in mortality in a recent trial. The company has also received FDA Fast Track designation for its COVID-19 program and is advancing its late-stage cancer therapies.

Veru Inc. (NASDAQ: VERU) presented promising results from its Phase 2 study of sabizabulin for severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) at the ECCMID conference in Lisbon. The study showed an 82% relative reduction in deaths (p=0.0442) and a reduction in ICU days from 9.6 to 2.6 days (p=0.0261). These results support advancing to a Phase 3 study, which previously halted for overwhelming efficacy. The company is pursuing FDA emergency use authorization and aims to bring sabizabulin to patients promptly.

Veru Inc. (VERU) announced positive results from a Phase 3 clinical trial of sabizabulin for hospitalized COVID-19 patients at high risk for ARDS. The Independent Data Monitoring Committee has recommended early termination of the trial due to a statistically significant 55% reduction in deaths compared to placebo (p=0.0029). The treatment was well tolerated, showing a comparable safety profile to placebo. Veru will meet with the FDA to seek emergency use authorization and has initiated manufacturing processes to prepare for anticipated demand.