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) reported a significant 43% increase in net revenues, reaching $9.9 million for Q2 FY 2020, and a 61% rise in gross profit to $7.4 million. The gross margin improved to 75%. The company is progressing in its clinical trials, with positive Phase 1b results for VERU-111 in treating advanced prostate cancer and FDA clearance for a Phase 2 COVID-19 study. Operating loss narrowed to $0.3 million compared to $2.1 million last year. The results highlight strong growth in prescription sales and bolster Veru's position in oncology therapeutics.
Veru Inc. (NASDAQ: VERU) has received FDA approval to initiate a Phase 2 clinical trial for VERU-111, an oral microtubule depolymerization agent, targeting COVID-19 treatment. This trial will assess its efficacy in hospitalized patients at high risk for acute respiratory distress syndrome (ARDS). The trial will involve 40 subjects, comparing VERU-111 to a placebo over 21 days. Following its promising Phase 1b results in prostate cancer, this dual-action agent aims to combat both the virus and inflammatory responses associated with COVID-19.
Veru Inc. announced promising results from the Phase 1b segment of the VERU-111 clinical trial for treating men with metastatic castration-resistant prostate cancer. The study, which included 39 subjects, verified the drug's safety at doses ≤63 mg, with no significant neutropenia or neurotoxicity. Notably, 75% of patients showed PSA declines, and the median duration of response was 10 months. The company plans to collaborate with the FDA next quarter to design a Phase 3 trial, aiming to position VERU-111 as a front-line treatment before chemotherapy.