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. 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.
Veru Inc. (NASDAQ: VERU) has engaged Morgan Stanley as a financial advisor to explore strategic alternatives for its FC2 Female Condom® business. The company reported record revenue and gross profit from this segment, with fiscal 2020 net revenues at $41 million and gross profit of $29 million. Veru is considering the monetization of the FHC Business due to a shift towards late-stage clinical programs, including trials for oncology and COVID-19. Despite exploring options, Veru remains open to continuing the FHC Business if beneficial for shareholders.
Veru Inc. (NASDAQ: VERU) announced its participation in the H.C. Wainwright Global Life Sciences Conference, with a fireside chat available on-demand starting March 9, 2021, at 7 a.m. ET. The chat can be accessed via their website for at least 90 days. Veru focuses on developing novel medicines for prostate and breast cancer, with key products including VERU-111 and VERU-100, and is advancing clinical trials for COVID-19 treatments. The company also offers the FC2 Female Condom as part of its sexual health division and submitted a New Drug Application for TADFIN™ for benign prostatic hyperplasia.
Veru Inc. has successfully completed an expedited end of Phase 2 trial meeting with the FDA regarding its treatment, VERU-111, for hospitalized COVID-19 patients. The FDA recognized the clinically meaningful benefits of VERU-111 in reducing respiratory failure and mortality rates, allowing the drug to advance into a Phase 3 clinical study. This study is expected to commence in April 2021 and will include approximately 400 patients. The Phase 2 trial showed an 81% relative reduction in treatment failures and a significant drop in ICU days.
Veru Inc. announced the submission of a 505(b)(2) New Drug Application (NDA) to the FDA for TADFIN™, a combination capsule of tadalafil 5mg and finasteride 5mg, intended for daily oral use to treat benign prostatic hyperplasia (BPH). This milestone marks Veru’s first NDA submission, aiming for FDA approval by December 2021. If approved, TADFIN will enhance Veru's sexual health revenue, which includes the existing FC2 Female Condom. The company plans to leverage telemedicine for launching TADFIN, anticipating a significant reduction in marketing costs.
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