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.
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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.