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), an oncology biopharmaceutical company, announced the acceptance of two abstracts for presentation at the 39th Miami Breast Cancer Conference on March 3-6, 2022. The studies focus on enobosarm's efficacy and safety for treating AR+ ER+ HER2- metastatic breast cancer. Veru's ongoing initiatives include the Phase 3 ARTEST study on enobosarm and a clinical collaboration with Lilly for the ENABLAR-2 study. The company also develops new drugs for prostate cancer and has a COVID-19 treatment study underway, both receiving FDA Fast Track designations.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, at 11:20 am ET. The presentation will focus on Veru's development of novel medications for breast and prostate cancers, including the Phase 3 ARTEST study of enobosarm and various ongoing studies for sabizabulin. A webcast will be available at verupharma.com/investors and archived for 30 days.
Veru Inc. (NASDAQ: VERU) announced updated clinical data from a Phase 1b/2 study of sabizabulin in men with metastatic castration-resistant prostate cancer, presented at the 2022 ASCO Genitourinary Cancers Symposium. The study showed promising results with a 20.7% overall response rate and 59% stable disease or objective response in patients with measurable disease. Sabizabulin also demonstrated good tolerability without significant adverse effects. The ongoing Phase 3 VERACITY trial will further evaluate its efficacy prior to IV chemotherapy.
Veru Inc. (NASDAQ: VERU) announced a successful planned conditional power analysis conducted by the Independent Data Monitoring Committee (IDMC) for its Phase 3 COVID-19 study of sabizabulin, which targets hospitalized patients with a high risk for acute respiratory distress syndrome (ARDS). The IDMC confirmed that the study should continue as originally designed, with clinical results anticipated in the first half of 2022. The study has received Fast Track designation from the FDA, affirming the urgent need for effective COVID-19 therapies.
Veru Inc. (NASDAQ: VERU) announced its fiscal 2022 Q1 results, revealing a 3% decline in total net revenues to $14.1 million from $14.6 million. However, US FC2 prescription net revenues increased by 27% to $11.6 million. The company's gross profit rose by 9% to $11.8 million, with a gross margin reaching a record 84%. While the net loss was $6.4 million compared to a net income of $17.2 million in the previous year, Veru received FDA Fast Track designations for its COVID-19 and breast cancer drug trials.
Veru Inc. (NASDAQ: VERU) announced the upcoming Phase 3 ENABLAR-2 trial set to begin in Q1 2022. The trial will evaluate enobosarm in combination with Eli Lilly's Verzenio (abemaciclib) as a second-line treatment for AR+ER+HER2- metastatic breast cancer. Veru will conduct the trial, while Lilly provides Verzenio. The study aims to enroll 186 patients and assess efficacy via progression-free survival, with secondary endpoints including overall response rate. Enobosarm is a selective androgen receptor targeting agonist that has shown promise in improving outcomes for this patient demographic.
Veru Inc. (NASDAQ: VERU) has secured FDA Fast Track designation for its Phase 3 clinical program investigating sabizabulin, aimed at treating hospitalized COVID-19 patients at risk for Acute Respiratory Distress Syndrome (ARDS). This designation highlights the urgent need for effective treatments as COVID-19 cases surge. The Phase 3 trial involves 300 patients across multiple countries, with clinical results expected in the first half of 2022. Sabizabulin's dual anti-viral and anti-inflammatory effects target both SARS-CoV-2 and the cytokine storm associated with severe COVID-19.
Veru Inc. (NASDAQ: VERU) announced its fiscal 2022 Q1 financial results will be released on February 9, 2022, before market opens. A conference call with management is scheduled for the same day at 8 a.m. ET to discuss performance and answer questions. Veru focuses on oncology with drugs for breast and prostate cancers, including enobosarm and sabizabulin, and is also conducting a Phase 3 study for sabizabulin in COVID-19 patients. The company collaborates with Roche/Ventana for companion diagnostics and is advancing its sexual health division with products like ENTADFI.
Veru Inc. (NASDAQ: VERU) has received FDA Fast Track designation for enobosarm, aimed at treating AR+ ER+ HER2- metastatic breast cancer. This designation is significant for expediting drug development for serious conditions. Enobosarm is currently being evaluated in the Phase 3 ARTEST study for patients who have progressed on multiple therapies. The company is dedicated to developing innovative treatments for breast and prostate cancers, with ongoing studies to improve patient outcomes in challenging cases.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the H.C. Wainwright BioConnect Conference from January 10-13, 2022, starting at 7:00 am EST on January 10th. A webcast of the presentation will be available on their website, which will remain accessible for 30 days. Veru focuses on developing treatments for breast and prostate cancers, including enobosarm and sabizabulin. The company also has a sexual health division, funding its drug development. Current studies include late-stage trials for these cancer treatments and a Phase 3 COVID-19 study for sabizabulin.