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 plans for an underwritten public offering of its common stock, subject to market conditions. The company may grant underwriters a 30-day option to purchase an additional 15% of the offered shares. Proceeds from this offering will support research, clinical trials, regulatory costs, marketing, and general corporate purposes. The offering is filed under an effective shelf registration statement with the SEC, with Jefferies acting as book-running manager. There is no guarantee on the offering's completion or terms.
Veru Inc. (NASDAQ: VERU) reported record net revenues of $15 million and gross profit of $11 million in Q1 FY21, up 38% and 49% respectively. The company is advancing its oncology drug pipeline, particularly focusing on prostate and breast cancer treatments, with multiple Phase 3 clinical trials expected to start in 2021. A positive Phase 2 trial of VERU-111 for COVID-19 showed a significant 81% reduction in death or respiratory failure among hospitalized patients. Veru aims to submit a New Drug Application for TADFIN next week, which could bolster its financial position.
Veru Inc. (NASDAQ: VERU) announces positive Phase 2 clinical trial results for VERU-111, an oral treatment for hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). The trial showed an 81% relative reduction in death or respiratory failure at Day 29 and 82% relative decrease in mortality compared to placebo. Patients receiving VERU-111 had fewer ICU days and mechanical ventilation needs. The company aims for a Phase 3 trial to start in April 2021, with a focus on regulatory discussions with the FDA.
Veru Inc. (NASDAQ: VERU) will release its fiscal 2021 first quarter financial results on February 10, 2021, before market opening. A conference call will be held at 8 a.m. ET on the same day to discuss the company’s performance and answer questions. Veru focuses on oncology, developing treatments for prostate and breast cancer, including clinical trials for its drug candidates VERU-111 and VERU-100. The company is also advancing multiple clinical trials across its pipeline and will provide insights into future developments during the call.
Veru Inc. announced a significant breakthrough in breast cancer research, revealing the androgen receptor acts as a tumor suppressor in ER+ breast cancer. Preclinical studies indicate that enobosarm, a selective androgen receptor agonist, shows potent antitumor activity in resistant cases. The Phase 3 ARTEST study for enobosarm is set to commence next quarter, targeting patients resistant to existing therapies. This research could change treatment approaches and emphasizes enobosarm's potential without unwanted side effects, marking a new era in breast cancer treatment.
Veru Inc. (NASDAQ: VERU) announced its participation in the H.C. Wainwright Bioconnect 2021 Conference, with an on-demand presentation available from January 11-14, 2021. The webcast will also be archived for 90 days. Veru focuses on oncology, developing treatments for prostate and breast cancer, including investigational drugs such as VERU-111, VERU-100, and enobosarm. The company plans to advance various clinical trials throughout 2021.
Veru Inc. (NASDAQ: VERU) announced promising results from its Phase 2 clinical trial for enobosarm, focused on ER+/HER2- metastatic breast cancer. Highlighted as a Spotlight Presentation at the 2020 San Antonio Breast Cancer Symposium, enobosarm showed a clinical benefit rate of 32% in a 136-patient cohort. The FDA has approved a Phase 3 ARTEST study, set to begin in Q2 2021, to further evaluate enobosarm's efficacy against active comparators in similar patient populations. This novel therapy offers hope for patients who have exhausted other treatment options.
Veru Inc. (NASDAQ: VERU) presented promising preclinical data for VERU-111, showing its potential in treating triple negative breast cancer (TNBC) resistant to paclitaxel. Findings from the 2020 San Antonio Breast Cancer Symposium revealed that VERU-111 significantly inhibited tumor growth in both paclitaxel-sensitive and resistant models. The company plans to engage with the FDA in early 2021 to discuss advancing VERU-111 into a Phase 2b clinical trial for women with taxane-resistant TNBC, potentially leading to accelerated approval.
Veru Inc. (NASDAQ: VERU) has completed its transformation into a late-stage oncology biopharmaceutical company focused on prostate and breast cancer therapies. It has licensed worldwide rights to enobosarm, an oral androgen receptor targeting agent for endocrine-resistant ER+ HER2- metastatic breast cancer. Veru plans to initiate four registration trials in 2021, including the ARTEST trial for enobosarm and studies for VERU-111 and VERU-100. The company expects to fund these trials through existing resources without the need for new equity financing until at least FY 2022.
Veru Inc. (NASDAQ: VERU) reported record financial results for fiscal 2020, with net revenues rising 34% to $42.6 million and gross profit increasing 42% to $30.8 million. Notably, FC2 prescription sales surged 93% to $27.1 million. Despite a net loss of $19 million, which included a $14.1 million non-cash impairment charge, adjusted operating loss improved significantly. The company completed the $20 million sale of its PREBOOST business and anticipates that current cash and operational cash flow will support drug development through at least fiscal 2022. Key clinical trials are advancing, including a late-stage breast cancer drug entering Phase 3.