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) 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.
Veru Inc. (NASDAQ: VERU) reported a strong Q2 fiscal 2021, with net revenues increasing by 34% to $13.3 million and gross profit rising 47% to $10.9 million. The gross margin improved to 82%. The company is set to enroll patients in multiple pivotal clinical trials for its drug candidates, including sabizabulin for high-risk COVID-19 patients and prostate cancer therapies. Despite the growth, net loss increased to $2.8 million or $0.04 per share. Cash reserves stood at $136.7 million.
Veru Inc. (NASDAQ: VERU) announced results from a Phase 2 clinical study of enobosarm, an oral selective androgen receptor targeting agonist, in women with AR+ER+HER2- advanced breast cancer. The subset analysis revealed a 50% clinical benefit rate at 24 weeks and a 30% best objective tumor response, including complete responses in 2 patients. The average radiographic progression-free survival was 10 months at the 9mg dose. A Phase 3 trial, ARTEST, is expected to begin in June 2021, focusing on similar patient demographics.
Veru Inc. (NASDAQ: VERU) announced it will report its fiscal 2021 second quarter financial results on May 12, 2021, before market opening. The company specializes in oncology, focusing on prostate and breast cancer treatments. Critical products under development include sabizabulin, with a Phase 3 study targeting metastatic prostate cancer expected to begin in Q2 2021, and enobosarm for breast cancer, also anticipated to launch Phase 3 trials in Q2 2021. A conference call will be held at 8 a.m. ET on the same day to discuss performance and answer questions.
Veru Inc. (NASDAQ: VERU) announced acceptance of clinical results from the Phase 2 study of enobosarm, a selective androgen receptor targeting agonist, for presentation at the ESMO Breast Cancer Virtual Congress 2021 (May 5-8). This study focused on patients with AR+ER+HER2- advanced breast cancer who failed estrogen blockers and CDK 4/6 inhibitors. The upcoming Phase 3 ARTEST trial will evaluate enobosarm against active controls in patients with progressed disease. The company remains optimistic about the potential of enobosarm in targeted treatments for breast cancer.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the Oppenheimer 31st Annual Healthcare Conference on March 16th at 3:10 p.m. ET. The presentation will focus on Veru’s pipeline for managing prostate and breast cancer, including innovations like VERU-111 and VERU-100. The webcast will be archived for 90 days. Additionally, Veru is advancing TADFIN™ for benign prostatic hyperplasia. Investors can access more information on the presentation and products at Veru's investor website.
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