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) announced its participation in four upcoming healthcare investor conferences, aimed at discussing its innovative biopharmaceutical solutions for prostate cancer management. The conferences include the Morgan Stanley Virtual Healthcare Conference from September 14-18, 2020, and the Cantor Fitzgerald Global Healthcare Conference on September 15-17, where Veru will present on September 15 at 8:00 a.m. ET. Additionally, the company will present at the H.C. Wainwright Conference on September 16 and the Oppenheimer Summit on September 21, with a focus on its pipeline products, including VERU-111 and VERU-100.
Veru Inc. (NASDAQ: VERU) has signed a three-year multi-million unit extension agreement with Roman, a leader in men's digital health, for the exclusive U.S. distribution of its PREBOOST® (4% benzocaine wipes) under the Roman Swipes brand. The partnership aims to increase patient access to this product for the treatment of premature ejaculation (PE), which affects 20-30% of men. Mitchel Steiner, CEO, emphasized the importance of this collaboration in providing convenient, clinically-backed treatments.
Veru Inc. (NASDAQ: VERU) reported a 6% increase in net revenues to $10.3 million for Q3 2020, driven by a 23% rise in U.S. prescription sales of FC2®. Gross profit for the quarter was 63%, with an operating loss narrowing to $1.4 million. Year-to-date revenues surged 34% to $30.8 million, buoyed by a remarkable 95% increase in FC2 sales. The company also received positive FDA input on the Phase 3 trial design for VERU-111, aiming for metastatic prostate cancer treatment, with plans to commence in Q1 2021. Investor conference call held today at 8 a.m. ET.
Veru Inc. (NASDAQ: VERU) has announced that VERU-111 has shown significant anti-inflammatory effects in vitro, targeting key cytokines involved in the cytokine storm related to COVID-19. In a University of Tennessee study, VERU-111 effectively reduced levels of TNFα, IL-1α, IL-1β, IL-6, and IL-8 by substantial percentages, indicating its potential for treating the severe respiratory syndrome. A Phase 2 clinical trial is currently enrolling 40 patients to evaluate its efficacy in preventing acute respiratory distress syndrome (ARDS) in high-risk COVID-19 patients.
Veru Inc. (NASDAQ: VERU) plans to release its fiscal 2020 third-quarter financial results on August 13, 2020, prior to the market opening. The company's management will conduct a conference call at 8 a.m. ET to discuss performance and answer questions. Veru is engaged in developing treatments for prostate cancer, including VERU-111 and VERU-100, with ongoing clinical studies. The company is also advancing its specialty pharmaceutical pipeline, including TADFIN for benign prostatic hyperplasia. The call will be available via webcast and archived for three months.
Veru Inc. (NASDAQ: VERU) announced that results from its Phase 1b/2 study of VERU-111, a novel treatment for metastatic castration-resistant prostate cancer, will be presented at the ESMO Virtual Congress 2020 on September 19-21, 2020. The study evaluates patients who have failed androgen receptor-targeting agents like enzalutamide. Enrollment for the ongoing Phase 2 study is nearing completion. Veru continues to advance its pipeline of products targeting unmet medical needs in urology and oncology.
Veru Inc. (NASDAQ: VERU) announced FDA regulatory clarity on the Phase 3 trial design for VERU-111, an oral treatment targeting metastatic castration-resistant prostate cancer. The FDA accepted the trial's focus on pre-chemotherapy patients and approved radiographic progression-free survival as a primary endpoint. This lowers the required sample size to approximately 200-300 participants. The final protocol submission is planned for Q4 2020, with a Phase 3 study anticipated to start in Q1 2021. The milestone signifies a significant step forward in addressing unmet medical needs in prostate cancer treatment.
Veru Inc. (NASDAQ: VERU) has been added to the Russell 2000® and Russell 3000® Indices, effective today, following Russell's annual reconstitution. This inclusion is expected to enhance visibility and attract investment. The Russell 2000 Index includes small-cap stocks representing about 10% of the total market cap of the Russell 3000 Index, which covers approximately 98% of the U.S. equity market. Veru focuses on developing treatments for prostate cancer, with several products in clinical trials and a growing portfolio in urology.
Veru Inc. (NASDAQ: VERU) has commenced its Phase 2 clinical trial for VERU-111, a microtubule depolymerization drug aimed at treating COVID-19. The trial will enroll 40 hospitalized patients at high risk for acute respiratory distress syndrome (ARDS). Patients will receive either VERU-111 or a placebo for 21 days. The drug has shown potential for inhibiting SARS-CoV-2 and alleviating severe inflammation related to the virus. The primary endpoint is the proportion of patients alive without respiratory distress by Day 29. Quick enrollment is anticipated due to rising COVID-19 cases.
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on oncology and urology, will present at the Jefferies Virtual Healthcare Conference on June 2, 2020, at 9:30 a.m. ET. The presentation will cover the company's prostate cancer treatments, including VERU-111, which is currently in clinical trials for metastatic castration-resistant prostate cancer. Other pipeline products include Zuclomiphene citrate and VERU-100, targeting advanced prostate cancer. A webcast of the presentation will be available on their website for at least 90 days post-event.