Veru Stock Price, News & Analysis

Veru Inc. (NASDAQ: VERU), a biopharmaceutical company, will host a conference call and audio webcast on May 11, 2023, at 8:00 a.m. ET to discuss its fiscal 2023 Q2 financial results and provide a business update. Interested investors can access the call through the company's website or by dialing specified telephone numbers. Veru is focused on developing treatments for breast cancer and SARS-CoV-2, with ongoing clinical trials for its candidates, including enobosarm for metastatic breast cancer and sabizabulin for COVID-19. Sabizabulin has shown a statistically significant 51.6% reduction in deaths in a Phase 3 trial. The company plans to conduct further trials and has received Fast Track designation from the FDA for its COVID-19 treatment.

Veru Inc. (NASDAQ: VERU) has announced the sale of its ENTADFI^® business to Blue Water Vaccines, Inc. for a total of $20 million, with potential additional earnings of up to $80 million based on sales milestones. The deal includes an upfront payment of $6 million and scheduled payments of $4 million in fiscal 2023 and $10 million in fiscal 2024. This move aims to provide Veru with the financial flexibility needed to further develop its drug candidates, namely enobosarm for metastatic breast cancer and sabizabulin for SARS-CoV-2 related complications, with Phase 3 data anticipated in 2024. The company is also advancing multiple studies focusing on infectious diseases and oncology.

Veru Inc. (NASDAQ: VERU) has announced a Purchasing Agreement with Afaxys Group Services, LLC (AGS) to supply its FC2 Female Condom® through AGS's Group Purchasing Organization. This agreement aims to provide affordable contraceptive options to approximately 31 million individuals relying on community health services. The FC2 Female Condom is FDA-approved and serves dual functions: preventing unintended pregnancies and reducing sexually transmitted infections, including HIV/AIDS. A preferred pricing model will ensure access for healthcare providers serving underrepresented populations. Dr. Mitchell Steiner, Veru's CEO, highlighted the agreement's role in enhancing accessibility to sexual and reproductive health services.

Veru Inc. (NASDAQ: VERU) has reported promising results from a preclinical study of sabizabulin, demonstrating its ability to inhibit the release and spread of the poxvirus, specifically the vaccinia virus. Conducted by researchers at the University of Rochester, the study showed significant dose-dependent inhibition of viral release and cell-to-cell spread at concentrations achievable with a 9mg daily oral dose. This breakthrough supports Veru's plans to expand sabizabulin's applications to combat smallpox and other related infections, especially during potential outbreaks. The company is set to meet with the FDA for a pre-Investigational New Drug meeting to discuss the Animal Rule regulatory pathway, indicating a strategic move towards clinical development for this promising antiviral.

Veru Inc. (NASDAQ: VERU) announced promising results from a preclinical study of sabizabulin, showing robust anti-inflammatory effects in a mouse model for influenza-induced Acute Respiratory Distress Syndrome (ARDS). The study demonstrated a significant reduction in inflammatory cells by 53% and critical cytokines like IL-6 by 74%. Following a positive Phase 3 COVID-19 clinical trial, Veru plans to initiate a Phase 3 study for hospitalized influenza patients at high risk for ARDS. The FDA granted an expedited meeting to discuss the confirmatory Phase 3 study for COVID-19. These developments highlight sabizabulin's potential as a broad antiviral and anti-inflammatory agent.

Veru Inc. (NASDAQ: VERU) announced that its CEO, Mitchell Steiner, will present at the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023, at 12 pm ET. The presentation will outline the company's corporate strategy focusing on the clinical development of drug candidates targeting COVID-19 and oncology, with Phase 3 clinical trial data expected in 2024. A live webcast of the event will be available on the company’s website, with an archived version to follow. Veru specializes in developing treatments for infectious diseases and oncology and has FDA-approved products in its sexual health program.

On March 2, 2023, Veru announced that the FDA declined its request for Emergency Use Authorization (EUA) for sabizabulin, a treatment for hospitalized adults with moderate to severe COVID-19 at high risk for Acute Respiratory Distress Syndrome (ARDS). The FDA cited unknown influences affecting the study despite agreeing the Phase 3 trial met its primary endpoint. However, the FDA expressed willingness to collaborate on a new Phase 3 study that could lead to an EUA or NDA approval. The company continues to seek authorization for sabizabulin from other regulatory agencies globally.

Veru Inc. (NASDAQ: VERU) announced significant updates regarding sabizabulin, which is under review for emergency authorization to treat COVID-19 by multiple global regulatory agencies. A late-breaker presentation at IDWeek revealed an 81.2% relative reduction in deaths compared to placebo in severe COVID-19 patients. Financially, the company reported a decrease in net revenues to $2.5 million from $14.1 million year-over-year and an operating loss of $35.6 million. Cash reserves decreased to $46.9 million. Veru is actively enrolling in clinical trials for cancer treatments and optimizing revenue strategies in its sexual health program.

Veru Inc. has scheduled a conference call and audio webcast for February 9, 2023, at 8:00 a.m. ET to discuss its fiscal 2023 first quarter financial results and provide a business update. The call will cover key developments related to its product pipeline, including sabizabulin for COVID-19 and enobosarm for oncology. Notably, sabizabulin has shown a 51.6% reduction in deaths in its Phase 3 trial, and its review is pending by various regulatory authorities, including the U.S. FDA. Investors can access the webcast on the company's website, and a replay will be available for three months.