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) announced that the FDA has agreed that no additional efficacy studies or safety data are required for Emergency Use Authorization (EUA) of its COVID-19 treatment, sabizabulin. A EUA application is planned for submission in Q2 2022. The Phase 3 study demonstrated a 55.2% reduction in mortality among hospitalized patients with COVID-19. The company has begun scaling up production and is in discussions for advance purchase agreements with government officials. A conference call is scheduled for May 12, 2022, to discuss FDA meeting outcomes and next steps.
On May 2, 2022, Veru Inc. (NASDAQ: VERU) announced that the FDA granted a pre-Emergency Use Authorization meeting set for May 10, 2022, following the positive results from a Phase 3 COVID-19 study on sabizabulin. The trial demonstrated a significant 55% reduction in death rates among hospitalized patients. The company aims to expedite the EUA process as COVID-19 cases rise. Veru is also advancing its breast cancer and prostate cancer drug portfolios, with multiple studies ongoing or planned, including collaborations with Eli Lilly.
Veru Inc. (NASDAQ: VERU) will announce its fiscal 2022 second quarter financial results on May 12, 2022, prior to market opening. A conference call is scheduled for the same day at 8 a.m. ET to discuss company performance and answer questions. The call will be accessible via phone and webcast. Veru is developing treatments for COVID-19 and cancers, with its COVID-19 candidate sabizabulin showing a 55% reduction in mortality in a recent trial. The company has also received FDA Fast Track designation for its COVID-19 program and is advancing its late-stage cancer therapies.
Veru Inc. (NASDAQ: VERU) presented promising results from its Phase 2 study of sabizabulin for severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) at the ECCMID conference in Lisbon. The study showed an 82% relative reduction in deaths (p=0.0442) and a reduction in ICU days from 9.6 to 2.6 days (p=0.0261). These results support advancing to a Phase 3 study, which previously halted for overwhelming efficacy. The company is pursuing FDA emergency use authorization and aims to bring sabizabulin to patients promptly.
Veru Inc. (VERU) announced positive results from a Phase 3 clinical trial of sabizabulin for hospitalized COVID-19 patients at high risk for ARDS. The Independent Data Monitoring Committee has recommended early termination of the trial due to a statistically significant 55% reduction in deaths compared to placebo (p=0.0029). The treatment was well tolerated, showing a comparable safety profile to placebo. Veru will meet with the FDA to seek emergency use authorization and has initiated manufacturing processes to prepare for anticipated demand.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, announced the acceptance of two abstracts for presentation at the 39th Miami Breast Cancer Conference on March 3-6, 2022. The studies focus on enobosarm's efficacy and safety for treating AR+ ER+ HER2- metastatic breast cancer. Veru's ongoing initiatives include the Phase 3 ARTEST study on enobosarm and a clinical collaboration with Lilly for the ENABLAR-2 study. The company also develops new drugs for prostate cancer and has a COVID-19 treatment study underway, both receiving FDA Fast Track designations.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, at 11:20 am ET. The presentation will focus on Veru's development of novel medications for breast and prostate cancers, including the Phase 3 ARTEST study of enobosarm and various ongoing studies for sabizabulin. A webcast will be available at verupharma.com/investors and archived for 30 days.
Veru Inc. (NASDAQ: VERU) announced updated clinical data from a Phase 1b/2 study of sabizabulin in men with metastatic castration-resistant prostate cancer, presented at the 2022 ASCO Genitourinary Cancers Symposium. The study showed promising results with a 20.7% overall response rate and 59% stable disease or objective response in patients with measurable disease. Sabizabulin also demonstrated good tolerability without significant adverse effects. The ongoing Phase 3 VERACITY trial will further evaluate its efficacy prior to IV chemotherapy.
Veru Inc. (NASDAQ: VERU) announced a successful planned conditional power analysis conducted by the Independent Data Monitoring Committee (IDMC) for its Phase 3 COVID-19 study of sabizabulin, which targets hospitalized patients with a high risk for acute respiratory distress syndrome (ARDS). The IDMC confirmed that the study should continue as originally designed, with clinical results anticipated in the first half of 2022. The study has received Fast Track designation from the FDA, affirming the urgent need for effective COVID-19 therapies.
Veru Inc. (NASDAQ: VERU) announced its fiscal 2022 Q1 results, revealing a 3% decline in total net revenues to $14.1 million from $14.6 million. However, US FC2 prescription net revenues increased by 27% to $11.6 million. The company's gross profit rose by 9% to $11.8 million, with a gross margin reaching a record 84%. While the net loss was $6.4 million compared to a net income of $17.2 million in the previous year, Veru received FDA Fast Track designations for its COVID-19 and breast cancer drug trials.
FAQ
What is the current stock price of Veru (VERU)?
What is the market cap of Veru (VERU)?
What does Veru Inc. specialize in?
What are the main divisions of Veru Inc.?
What is the FC2 Female Condom?
What is enobosarm?
What is sabizabulin?
What recent FDA clearance did Veru receive?
What are Veru’s recent financial highlights?
Has Veru faced any compliance issues recently?
What is Veru’s role in global health?
What are the expected timelines for Veru’s clinical trials?
