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 promising results from a Phase 3 trial of sabizabulin for hospitalized COVID-19 patients requiring supplemental oxygen. Presented at IDWeek 2022, findings indicated a 55.2% relative reduction in mortality and significant decreases in ICU stays and mechanical ventilation days. In patients with comorbidities, there was an 81.2% relative reduction in deaths. Sabizabulin showed good tolerability, and the trial's success has led to plans for emergency use authorization discussions with the FDA.
Veru Inc. (NASDAQ: VERU) announced that data from its Phase 3 trial of sabizabulin for hospitalized COVID-19 patients requiring supplemental oxygen will be presented at IDWeek 2022, occurring from October 19-23 in Washington, D.C. The late-breaking presentation, titled 'Clinical Benefit of Oral sabizabulin for Hospitalized Adults with COVID-19 on Supplemental Oxygen', is scheduled for October 21, 2022. The trial shows sabizabulin resulted in a 55.2% relative reduction in deaths compared to placebo, leading to a request for Emergency Use Authorization from the FDA.
Veru Inc. (NASDAQ: VERU) announced inducement awards for seven new employees as part of their employment agreement, complying with NASDAQ Listing Rule 5635(c)(4). The stock options granted amount to a total of 99,150 shares, vesting in three annual installments. The company is advancing its infectious disease and oncology programs, reporting positive Phase 3 study results for sabizabulin in COVID-19 patients, showing a 55.2% reduction in deaths. Veru is also engaged in multiple ongoing clinical trials for breast and prostate cancers, aiming for regulatory approvals and market access.
Veru Inc. (NASDAQ: VERU) announced its participation in the Cantor Oncology, Hematology, HemeOnc Conference on September 28, 2022, in New York City. The biopharmaceutical company is focused on developing treatments for COVID-19 and cancers. A recent Phase 3 study of sabizabulin showed a significant 55.2% reduction in deaths among hospitalized COVID-19 patients. The FDA is set to discuss emergency use authorization for sabizabulin on November 9, 2022. The company also has ongoing studies for its oncology portfolio, including enobosarm for breast cancer.
Veru Inc. (NASDAQ: VERU) announced that the FDA has rescheduled the advisory committee meeting regarding Emergency Use Authorization for sabizabulin in COVID-19 patients at high risk for ARDS to November 09, 2022. The agenda remains unchanged. A positive Phase 3 study of sabizabulin in hospitalized COVID-19 patients showed a statistically significant 55.2% reduction in deaths compared to placebo. Additionally, the Company is progressing with late-stage studies for breast and prostate cancer treatments, including enobosarm and sabizabulin.
Veru Inc. (NASDAQ: VERU) announced that the FDA will hold a meeting on October 6, 2022, to discuss the Emergency Use Authorization for sabizabulin as a treatment for hospitalized COVID-19 patients at high risk for ARDS. The FDA completed audits of clinical sites without reporting deficiencies. A Phase 3 trial demonstrated a 55.2% reduction in deaths for patients treated with sabizabulin compared to placebo, prompting the request for authorization. The company is also engaged in late-stage development for breast and prostate cancer treatment options.
Veru Inc. (NASDAQ: VERU) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 7:00 AM EDT. The company focuses on developing medicines for COVID-19, other viral diseases, and cancer treatments. They completed a Phase 3 COVID-19 study for sabizabulin, showing a 55.2% reduction in deaths for treated patients. Veru submitted a request for emergency use authorization for sabizabulin, with ongoing studies for enobosarm in breast cancer and ongoing trials for prostate cancer treatments.
On August 22, 2022, Veru announced that Australia’s TGA approved an expedited regulatory pathway for sabizabulin, designed for hospitalized COVID-19 patients at high risk of Acute Respiratory Distress Syndrome (ARDS). This provisional registration allows for quicker access to treatment in Australia. Veru's sabizabulin showed a statistically significant 55.2% reduction in deaths during a Phase 3 trial, prompting the company to pursue similar approvals from the FDA, EMA, and MHRA. The company is also advancing its oncology programs for breast and prostate cancer treatments.
Veru Inc. (NASDAQ: VERU) has appointed Jason Davies as the new Executive Vice President – General Manager overseeing EMEA, LATAM, and APAC for its Infectious Disease Franchise. Davies brings extensive experience from Janssen, where he led launch strategies across EMEA. This role is critical as Veru aims to enhance its international strategies and market potential for sabizabulin, a treatment for COVID-19. The company also reported positive results from its Phase 3 COVID-19 study, showing a 55.2% reduction in deaths among treated patients, with ongoing efforts for FDA emergency use authorization.
Veru Inc. (NASDAQ: VERU) announced inducement awards for five new employees, granting stock options for 128,450 shares under its 2022 Employment Inducement Equity Incentive Plan. The awards are a material inducement for the employees' entry into the company. Veru is focused on developing treatments for COVID-19, cancers, and ARDS-related diseases. The company has reported significant results in its Phase 3 COVID-19 study, showing a 55.2% reduction in deaths among treated patients. The study was halted for efficacy, and an emergency use authorization has been requested from the FDA.