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. (symbol: VERU) is a comprehensive biopharmaceutical company dedicated to advancing treatments in men’s and women’s health, as well as oncology. The company specializes in developing and commercializing innovative pharmaceuticals and medical devices.
Veru operates through three divisions:
- Pharmaceuticals and Devices: This division focuses on treatments for conditions such as benign prostatic hyperplasia, male infertility, prostate cancer, gout, sexual dysfunction, and side effects of hormonal therapies in men. For women's health, Veru is developing treatments targeting female sexual health and advanced breast and ovarian cancers.
- Consumer Health Products: This division includes the marketing and distribution of the FC2 Female Condom, the only FDA-approved female condom that offers dual protection against sexually transmitted infections, including HIV/AIDS and unintended pregnancies. Since its introduction, FC2 has been distributed to 144 countries.
- Public Sector: Veru collaborates with international health organizations, including ministries of health and the U.N., to improve global health outcomes. The company supplies large-scale tenders, such as a multi-year contract with the South African government for FC2.
Veru is currently in late-stage development for several pivotal pharmaceuticals:
- Enobosarm: A novel selective androgen receptor modulator (SARM) being developed to enhance fat loss while preserving muscle mass in overweight or obese patients receiving GLP-1 RA drugs. Enobosarm is also under investigation for treating metastatic breast cancer.
- Sabizabulin: A microtubule disruptor in Phase 3 clinical trials aimed at treating viral-induced acute respiratory distress syndrome (ARDS), particularly in hospitalized COVID-19 patients.
Recent achievements include the FDA's clearance for a Phase 2b clinical study of enobosarm, marking significant progress in its weight loss and muscle preservation programs. The company has also initiated the enrollment of patients for this study, with results expected by the end of 2024, and a follow-up study expected to complete by mid-2025.
Financially, Veru is committed to ensuring robust funding for its ongoing projects. Recent financial updates reveal successful financing rounds and strategic partnerships, positioning the company well for future growth and development. The company is also actively working to regain compliance with Nasdaq listing requirements following delays in its SEC filings.
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.
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.
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