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 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.
Veru Inc. (NASDAQ: VERU) will report its fiscal 2020 fourth quarter and year results on December 9, 2020, before the market opens. Management will host a conference call at 8 a.m. ET to discuss performance and answer questions. Veru focuses on developing novel medicines for prostate cancer, including VERU-111 and VERU-100. The company is advancing multiple clinical studies and expects to begin a Phase 2 trial for VERU-100 in Q1 2021 and submit the NDA for TADFYN® early next year.
Veru Inc. (NASDAQ: VERU) announced its participation in four upcoming healthcare investor conferences, aimed at discussing its innovative biopharmaceutical solutions for prostate cancer management. The conferences include the Morgan Stanley Virtual Healthcare Conference from September 14-18, 2020, and the Cantor Fitzgerald Global Healthcare Conference on September 15-17, where Veru will present on September 15 at 8:00 a.m. ET. Additionally, the company will present at the H.C. Wainwright Conference on September 16 and the Oppenheimer Summit on September 21, with a focus on its pipeline products, including VERU-111 and VERU-100.
Veru Inc. (NASDAQ: VERU) has signed a three-year multi-million unit extension agreement with Roman, a leader in men's digital health, for the exclusive U.S. distribution of its PREBOOST® (4% benzocaine wipes) under the Roman Swipes brand. The partnership aims to increase patient access to this product for the treatment of premature ejaculation (PE), which affects 20-30% of men. Mitchel Steiner, CEO, emphasized the importance of this collaboration in providing convenient, clinically-backed treatments.
Veru Inc. (NASDAQ: VERU) reported a 6% increase in net revenues to $10.3 million for Q3 2020, driven by a 23% rise in U.S. prescription sales of FC2®. Gross profit for the quarter was 63%, with an operating loss narrowing to $1.4 million. Year-to-date revenues surged 34% to $30.8 million, buoyed by a remarkable 95% increase in FC2 sales. The company also received positive FDA input on the Phase 3 trial design for VERU-111, aiming for metastatic prostate cancer treatment, with plans to commence in Q1 2021. Investor conference call held today at 8 a.m. ET.
Veru Inc. (NASDAQ: VERU) has announced that VERU-111 has shown significant anti-inflammatory effects in vitro, targeting key cytokines involved in the cytokine storm related to COVID-19. In a University of Tennessee study, VERU-111 effectively reduced levels of TNFα, IL-1α, IL-1β, IL-6, and IL-8 by substantial percentages, indicating its potential for treating the severe respiratory syndrome. A Phase 2 clinical trial is currently enrolling 40 patients to evaluate its efficacy in preventing acute respiratory distress syndrome (ARDS) in high-risk COVID-19 patients.
Veru Inc. (NASDAQ: VERU) plans to release its fiscal 2020 third-quarter financial results on August 13, 2020, prior to the market opening. The company's management will conduct a conference call at 8 a.m. ET to discuss performance and answer questions. Veru is engaged in developing treatments for prostate cancer, including VERU-111 and VERU-100, with ongoing clinical studies. The company is also advancing its specialty pharmaceutical pipeline, including TADFIN for benign prostatic hyperplasia. The call will be available via webcast and archived for three months.
Veru Inc. (NASDAQ: VERU) announced that results from its Phase 1b/2 study of VERU-111, a novel treatment for metastatic castration-resistant prostate cancer, will be presented at the ESMO Virtual Congress 2020 on September 19-21, 2020. The study evaluates patients who have failed androgen receptor-targeting agents like enzalutamide. Enrollment for the ongoing Phase 2 study is nearing completion. Veru continues to advance its pipeline of products targeting unmet medical needs in urology and oncology.
Veru Inc. (NASDAQ: VERU) announced FDA regulatory clarity on the Phase 3 trial design for VERU-111, an oral treatment targeting metastatic castration-resistant prostate cancer. The FDA accepted the trial's focus on pre-chemotherapy patients and approved radiographic progression-free survival as a primary endpoint. This lowers the required sample size to approximately 200-300 participants. The final protocol submission is planned for Q4 2020, with a Phase 3 study anticipated to start in Q1 2021. The milestone signifies a significant step forward in addressing unmet medical needs in prostate cancer treatment.
Veru Inc. (NASDAQ: VERU) has been added to the Russell 2000® and Russell 3000® Indices, effective today, following Russell's annual reconstitution. This inclusion is expected to enhance visibility and attract investment. The Russell 2000 Index includes small-cap stocks representing about 10% of the total market cap of the Russell 3000 Index, which covers approximately 98% of the U.S. equity market. Veru focuses on developing treatments for prostate cancer, with several products in clinical trials and a growing portfolio in urology.
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