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 the upcoming Phase 3 ENABLAR-2 trial set to begin in Q1 2022. The trial will evaluate enobosarm in combination with Eli Lilly's Verzenio (abemaciclib) as a second-line treatment for AR+ER+HER2- metastatic breast cancer. Veru will conduct the trial, while Lilly provides Verzenio. The study aims to enroll 186 patients and assess efficacy via progression-free survival, with secondary endpoints including overall response rate. Enobosarm is a selective androgen receptor targeting agonist that has shown promise in improving outcomes for this patient demographic.
Veru Inc. (NASDAQ: VERU) has secured FDA Fast Track designation for its Phase 3 clinical program investigating sabizabulin, aimed at treating hospitalized COVID-19 patients at risk for Acute Respiratory Distress Syndrome (ARDS). This designation highlights the urgent need for effective treatments as COVID-19 cases surge. The Phase 3 trial involves 300 patients across multiple countries, with clinical results expected in the first half of 2022. Sabizabulin's dual anti-viral and anti-inflammatory effects target both SARS-CoV-2 and the cytokine storm associated with severe COVID-19.
Veru Inc. (NASDAQ: VERU) announced its fiscal 2022 Q1 financial results will be released on February 9, 2022, before market opens. A conference call with management is scheduled for the same day at 8 a.m. ET to discuss performance and answer questions. Veru focuses on oncology with drugs for breast and prostate cancers, including enobosarm and sabizabulin, and is also conducting a Phase 3 study for sabizabulin in COVID-19 patients. The company collaborates with Roche/Ventana for companion diagnostics and is advancing its sexual health division with products like ENTADFI.
Veru Inc. (NASDAQ: VERU) has received FDA Fast Track designation for enobosarm, aimed at treating AR+ ER+ HER2- metastatic breast cancer. This designation is significant for expediting drug development for serious conditions. Enobosarm is currently being evaluated in the Phase 3 ARTEST study for patients who have progressed on multiple therapies. The company is dedicated to developing innovative treatments for breast and prostate cancers, with ongoing studies to improve patient outcomes in challenging cases.
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, will present at the H.C. Wainwright BioConnect Conference from January 10-13, 2022, starting at 7:00 am EST on January 10th. A webcast of the presentation will be available on their website, which will remain accessible for 30 days. Veru focuses on developing treatments for breast and prostate cancers, including enobosarm and sabizabulin. The company also has a sexual health division, funding its drug development. Current studies include late-stage trials for these cancer treatments and a Phase 3 COVID-19 study for sabizabulin.
Veru Inc. (NASDAQ: VERU) announced the FDA approval of ENTADFI (finasteride and tadalafil) for treating benign prostatic hyperplasia (BPH), addressing urinary tract symptoms in men. This capsule, taken once daily, is more effective than finasteride alone with fewer sexual side effects. Commercialization is set for early 2022 through Veru’s telemedicine and partnerships with GoodRx, aiming to tap into the multi-billion dollar BPH market. The approval represents a key milestone for Veru, boosting potential revenue streams to fund further oncology research.
Veru Inc. (NASDAQ: VERU) announced promising human preclinical data for its drug enobosarm, which shows enhanced androgen receptor expression and tumor suppression when used alone or with the CDK4/6 inhibitor palbociclib. Presented at the San Antonio Breast Cancer Symposium, the findings suggest that this combination may effectively combat resistant breast cancer types. Veru's ongoing Phase 3 trials for enobosarm, aimed at AR+ER+HER2- metastatic breast cancer patients, are supported by these results, which highlight enobosarm's potential as a targeted therapy.
Veru Inc. (NASDAQ: VERU) reported a 44% increase in fiscal 2021 net revenues, reaching $61 million, and a 56% rise in gross profit to $48 million. The fourth quarter saw net revenues climb 33% to $15.6 million and gross profit rise 29% to $12.3 million. Operating loss improved to $1.9 million from $11.3 million in FY2020. The company is advancing multiple clinical programs, including Phase 3 studies for sabizabulin, targeting COVID-19 and metastatic cancers. Anticipated clinical results for COVID-19 are expected in 1H 2022.
Veru Inc. (NASDAQ: VERU) will report its fiscal 2021 fourth quarter and full-year financial results on December 2, 2021, before market opens. Management will conduct a conference call at 8 a.m. ET to discuss the performance and answer questions. Veru focuses on oncology, developing treatments for breast and prostate cancer, including ongoing studies for drugs like enobosarm and sabizabulin. The company also has a Sexual Health Division with a PDUFA date for ENTADFI in December 2021. The release contains forward-looking statements regarding the efficacy and approval of its drug candidates.
Veru Inc. announced its inclusion in Deloitte’s Technology Fast 500™, recognizing significant growth in its revenue, which surged 212% from 2017 to 2020, primarily from its Sexual Health Division. The company focuses on oncology, particularly treatments for breast and prostate cancer. Key products include enobosarm and sabizabulin, with ongoing clinical studies for metastatic cancers and COVID-19 treatment. CEO Mitchell Steiner highlighted telemedicine as a growth driver, enabling further investment in their oncology pipeline.
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