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 the FDA approval of ENTADFI (finasteride and tadalafil) for treating benign prostatic hyperplasia (BPH), addressing urinary tract symptoms in men. This capsule, taken once daily, is more effective than finasteride alone with fewer sexual side effects. Commercialization is set for early 2022 through Veru’s telemedicine and partnerships with GoodRx, aiming to tap into the multi-billion dollar BPH market. The approval represents a key milestone for Veru, boosting potential revenue streams to fund further oncology research.
Veru Inc. (NASDAQ: VERU) announced promising human preclinical data for its drug enobosarm, which shows enhanced androgen receptor expression and tumor suppression when used alone or with the CDK4/6 inhibitor palbociclib. Presented at the San Antonio Breast Cancer Symposium, the findings suggest that this combination may effectively combat resistant breast cancer types. Veru's ongoing Phase 3 trials for enobosarm, aimed at AR+ER+HER2- metastatic breast cancer patients, are supported by these results, which highlight enobosarm's potential as a targeted therapy.
Veru Inc. (NASDAQ: VERU) reported a 44% increase in fiscal 2021 net revenues, reaching $61 million, and a 56% rise in gross profit to $48 million. The fourth quarter saw net revenues climb 33% to $15.6 million and gross profit rise 29% to $12.3 million. Operating loss improved to $1.9 million from $11.3 million in FY2020. The company is advancing multiple clinical programs, including Phase 3 studies for sabizabulin, targeting COVID-19 and metastatic cancers. Anticipated clinical results for COVID-19 are expected in 1H 2022.
Veru Inc. (NASDAQ: VERU) will report its fiscal 2021 fourth quarter and full-year financial results on December 2, 2021, before market opens. Management will conduct a conference call at 8 a.m. ET to discuss the performance and answer questions. Veru focuses on oncology, developing treatments for breast and prostate cancer, including ongoing studies for drugs like enobosarm and sabizabulin. The company also has a Sexual Health Division with a PDUFA date for ENTADFI in December 2021. The release contains forward-looking statements regarding the efficacy and approval of its drug candidates.
Veru Inc. announced its inclusion in Deloitte’s Technology Fast 500™, recognizing significant growth in its revenue, which surged 212% from 2017 to 2020, primarily from its Sexual Health Division. The company focuses on oncology, particularly treatments for breast and prostate cancer. Key products include enobosarm and sabizabulin, with ongoing clinical studies for metastatic cancers and COVID-19 treatment. CEO Mitchell Steiner highlighted telemedicine as a growth driver, enabling further investment in their oncology pipeline.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical firm, announced participation in the Jefferies London Healthcare Conference from November 16-18, 2021. The fireside chat is set for November 18, available on-demand starting at 8:00 am GMT. The discussion will focus on their innovative cancer treatments, particularly for breast and prostate cancers, highlighting their ongoing clinical trials for enobosarm and sabizabulin. For access to the webcast, visit verupharma.com.
Veru Inc. (NASDAQ: VERU) has initiated the Phase 3 ARTEST trial, enrolling its first patient for enobosarm, a targeted hormone therapy for AR+ER+HER2- metastatic breast cancer. This trial, conducted across 49 sites in the U.S. and Europe, aims to evaluate the efficacy and safety of enobosarm versus active controls for patients previously treated with estrogen blockers and CDK4/6 inhibitors. A companion diagnostic test will be developed to identify the most suitable candidates. The study targets around 210 patients and aims to address a significant unmet need in breast cancer treatment.
Veru Inc. (NASDAQ: VERU) announced positive updated clinical data for sabizabulin (VERU-111) from a Phase 1b/2 study involving 80 men with metastatic castration-resistant prostate cancer. Presented at the ESMO Congress 2021, the findings indicate a median radiographic progression-free survival of approximately 7.4 months. Sabizabulin demonstrated a favorable safety profile, with no serious adverse events reported. These results support ongoing Phase 3 VERACITY study, aiming to confirm the drug's efficacy and safety as a treatment option for patients who have failed prior therapies.
Veru Inc. (NASDAQ: VERU) announced that updated Phase 1b/2 clinical data for sabizabulin (VERU-111) in men with metastatic castration resistant prostate cancer will be presented at the ESMO Congress 2021, from September 16-21, 2021. Sabizabulin targets unique microtubule binding sites and aims to disrupt androgen receptor transport. The presentation takes place on September 19, 2021, by Dr. Mark C. Markowski. Meanwhile, the ongoing Phase 3 VERACITY trial evaluates sabizabulin against alternative treatments in chemotherapy-naïve patients.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, announced its participation in several upcoming healthcare investor conferences. Key dates include the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 20-23, and the Cantor Virtual Global Healthcare Conference from September 27-30, 2021. Presentations will be available online and archived for 90 days. Veru focuses on developing innovative treatments for prostate and breast cancer.