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. (NASDAQ: VERU) is a late clinical stage biopharmaceutical company whose news flow is closely tied to the development of its two lead small molecule drug candidates, enobosarm and sabizabulin. Company press releases emphasize cardiometabolic and inflammatory diseases, with a particular focus on obesity, chronic weight management, and inflammation in atherosclerotic cardiovascular disease.
Much of Veru’s recent news has centered on enobosarm, a selective androgen receptor modulator (SARM) being developed to make weight reduction by GLP-1 receptor agonist (GLP-1 RA) drugs more tissue selective for fat loss while preserving lean mass and physical function. Updates include topline efficacy and safety data from the Phase 2b QUALITY study and its Maintenance Extension, which evaluated enobosarm in older patients receiving semaglutide for weight reduction. The company has reported that enobosarm plus semaglutide preserved lean mass, increased fat loss, and reduced declines in stair climb power compared to placebo plus semaglutide, as well as reduced weight and fat regain after semaglutide discontinuation.
Investors following VERU news will also see announcements about regulatory interactions and trial design. Veru has disclosed a successful FDA meeting that, according to the company, provided regulatory clarity for enobosarm as a muscle preservation drug in combination with GLP-1 RA therapy for obesity, including guidance that incremental weight loss can serve as an acceptable primary endpoint and confirmation of the 3 mg dose for future development. News releases describe the planned Phase 2b PLATEAU study, designed to evaluate enobosarm 3 mg in patients with obesity initiating GLP-1 RA treatment, with endpoints focused on total body weight, body composition, and physical function.
Additional VERU headlines cover capital markets activity and corporate actions, such as an underwritten public offering to fund enobosarm development, a 1-for-10 reverse stock split, and Nasdaq notifications regarding minimum bid price compliance. Conference presentations at scientific meetings, collaborations on a modified release enobosarm formulation using Laxxon Medical’s SPID-Technology, and periodic financial results also feature prominently in the company’s news stream.
For investors and observers, the Veru news page provides a consolidated view of clinical trial milestones, FDA-related updates, financing transactions, and scientific presentations that shape the outlook for VERU’s cardiometabolic and inflammatory disease programs.
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.
Veru Inc. (NASDAQ: VERU) has appointed David D. Ho, M.D., as the Chairman of its Scientific Advisory Board (SAB). Dr. Ho, a renowned expert in infectious disease research, will help drive the clinical development of Veru’s infectious disease program, particularly focusing on sabizabulin, a new treatment for COVID-19. Earlier studies showed that sabizabulin reduced mortality by 55.2% in high-risk patients. Dr. Ho's expertise is expected to bolster Veru's efforts in bringing innovative therapies to market for COVID-19 and other viral diseases.
Veru Inc. (NASDAQ: VERU) announced that the U.S. FDA is reviewing its Emergency Use Authorization (EUA) application for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS. The company reported a net loss of $83.8 million for fiscal 2022, with total revenues decreasing to $39.4 million from $61.3 million in 2021. Despite a decline in FC2 revenue due to challenges with telemedicine customers, Veru is preparing for commercialization of sabizabulin. The company also highlighted ongoing clinical trials for various cancer treatments, including enobosarm and sabizabulin.
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.