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 robust Q3 FY21, with net revenues soaring by 71% to $18M and gross profit jumping 113% to $14M, both achieving record highs. Year-to-date revenues reached $46M, marking a 48% increase. The company is advancing its oncology pipeline, with multiple clinical trials for prostate and breast cancers underway. Cash and equivalents stood at $123M, ensuring investment capacity for ongoing programs. Veru also initiated a Phase 3 COVID-19 trial, bolstering its therapeutic portfolio as the pandemic persists.
Veru Inc. (NASDAQ: VERU) announced it will report its fiscal 2021 third-quarter financial results on August 12, 2021, before market opening. A conference call is scheduled for the same day at 8 a.m. ET to discuss performance and address questions. Veru is focused on oncology, developing treatments for prostate and breast cancer. Current clinical trials include sabizabulin targeting resistant prostate cancer and enobosarm for metastatic breast cancer. The company also has a Sexual Health Business, featuring the FDA-approved FC2 Female Condom.
Veru Inc. (NASDAQ: VERU) announced updated clinical results for sabizabulin (VERU-111) in a Phase 1b/2 trial targeting metastatic castration-resistant prostate cancer. The study results, well received for their potential effectiveness, will be presented at the European Association of Urology 36th Annual Congress from July 8-12, 2021. The company plans to advance the drug to a Phase 3 trial, named VERACITY, aiming to address a significant unmet medical need. Veru's pipeline also includes other treatments for breast cancer and COVID-19, indicating a robust commitment to oncology and sexual health management.
Veru Inc. has initiated its Phase 3 VERACITY clinical trial for sabizabulin, an innovative oral treatment for metastatic castration-resistant prostate cancer. This trial aims to evaluate sabizabulin's efficacy and safety against other androgen receptor-targeting agents. The study will enroll 245 patients across 45 sites in the U.S. Preliminary results from previous trials indicated sabizabulin was well-tolerated and demonstrated significant tumor efficacy. The primary endpoint is median radiographic progression-free survival, indicating sabizabulin's potential to address unmet medical needs in advanced prostate cancer treatment.
Veru Inc. (NASDAQ: VERU) has initiated a Phase 2 clinical trial for VERU-100, a new GnRH antagonist for treating hormone-sensitive advanced prostate cancer. The trial aims to assess the drug's efficacy and safety in 35 participants, with results expected by the second half of 2021. Current androgen deprivation therapies face limitations as no long-acting formulations exist. If successful, VERU-100 could fill an unmet need in prostate cancer care, potentially capturing a share of the $2.8 billion ADT market.
Veru Inc. (NASDAQ: VERU) reported significant findings from its Phase 2 study of enobosarm, an oral selective androgen receptor agonist, demonstrating strong antitumor effects in AR+ER+HER2- metastatic breast cancer patients with ≥ 40% AR expression. The study included 136 heavily pretreated subjects, and results indicated a 48% tumor response rate in those with ≥ 40% AR positivity. Enobosarm was well tolerated and shows potential as a new endocrine therapy. A Phase 3 ARTEST study is set to initiate in Q3 2021 to further assess enobosarm's efficacy.
Veru Inc. has reported promising results for sabizabulin in ongoing Phase 1b/2 clinical trials, showcasing its safety and efficacy in treating men with metastatic castration resistant prostate cancer. The study revealed a 20.7% overall response rate and a median progression-free survival of 10.8 months for some patients. A Phase 3 trial, named VERACITY, is set to commence this month, targeting a key market need. Dr. Mitchell Steiner emphasized potential broad use of sabizabulin prior to chemotherapy, marking an important step in prostate cancer treatment.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the Jefferies Virtual Healthcare Conference on June 1, 2021, at 8:00 a.m. ET. They focus on developing treatments for prostate and breast cancer, including sabizabulin and enobosarm. A Phase 3 clinical trial for sabizabulin targeting metastatic castration-resistant prostate cancer will start early June. The company’s product pipeline includes ongoing studies for enobosarm in breast cancer and other candidates. The presentation will be accessible for 90 days on their website.
Veru Inc. (NASDAQ: VERU) announced acceptance of two abstracts for presentation at the 2021 American Society of Clinical Oncology Annual Meeting. The abstracts include Phase 2 trial data of enobosarm for AR+ER+HER2- metastatic breast cancer and updated results of sabizabulin (VERU-111) in metastatic castration-resistant prostate cancer (mCRPC). Both agents are advancing to Phase 3 trials, with ARTEST for enobosarm expected to start in June 2021 and VERACITY for sabizabulin also anticipated early June 2021. These developments aim to address significant unmet needs in breast and prostate cancer treatment.
Veru Inc. has initiated a Phase 3 clinical trial for sabizabulin, targeting hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). This novel oral therapy, known for its anti-viral and anti-inflammatory properties, aims to reduce mortality rates. The trial will involve up to 300 subjects across multiple countries, comparing daily doses of 9mg sabizabulin to a placebo. A successful Phase 2 study indicated an 82% reduction in mortality rates among patients treated with sabizabulin, reinforcing its potential as a critical treatment during the ongoing pandemic.