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Veru - VERU STOCK NEWS

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.

Company Overview

Veru Inc. (NASDAQ: VERU) is a late clinical stage biopharmaceutical company that is transforming patient care through the development and commercialization of innovative therapeutics. With robust expertise in drug development and clinical research, Veru focuses on addressing complex medical challenges in cardiometabolic diseases, oncology, acute respiratory distress syndrome (ARDS), and sexual health. Its diversified portfolio demonstrates a deep understanding of therapeutic areas where significant unmet medical needs exist, and it uses advanced scientific methodologies to deliver novel treatment options.

Core Business Areas and Therapeutic Focus

The Company is uniquely positioned by virtue of its integrated approach across multiple treatment areas. Veru’s portfolio is built on three primary pillars: pharmaceutical and device development, consumer health products, and strategic initiatives in the public health sector. This multi-pronged focus allows the Company to address broad market segments including patients in need of improved weight management therapies, cancer treatments, and protection against sexually transmitted infections.

Innovative Drug Development Programs

At the forefront of its offerings is enobosarm, a novel, selective androgen receptor modulator (SARM) designed to preserve muscle mass and enhance fat loss, particularly in older, overweight individuals undergoing GLP-1 receptor agonist therapy. The clinical rationale behind enobosarm integrates deep pharmacological insights and expansive safety data, which spans multiple clinical trials. This therapeutic candidate is emblematic of Veru’s commitment to enhancing the quality and tissue selectivity of weight loss, ensuring that loss comes preferentially from adipose tissue while preserving muscle integrity and physical function.

Another important asset in Veru’s pipeline is sabizabulin, a microtubule disruptor with a unique mechanism aimed at reducing inflammation in conditions such as atherosclerotic cardiovascular disease. Sabizabulin distinguishes itself by targeting inflammatory pathways with stability in pharmacokinetics and low drug-drug interaction potential, positioning it as a promising candidate in an area historically challenged by safety concerns with older agents like colchicine.

Clinical Trials, Safety Profile, and Regulatory Rigor

Veru’s commitment to rigorous clinical evaluation is evident in its ongoing Phase 2b clinical trials, including the QUALITY study of enobosarm. These trials are designed to measure key endpoints such as changes in lean body mass, fat loss, and improvement in physical function through standardized tests. The Company leverages large clinical datasets and has established robust safety profiles through multiple studies involving diverse patient populations. Detailed statistical analyses have underscored the clinical rationale for enobosarm’s tissue selective effects, while the overall safety and tolerability data reinforce Veru’s dedication to patient welfare. Regulatory interactions are systematic and scientifically based, ensuring that all therapies progressing through development meet high standards of efficacy and safety.

Competitive Position and Market Significance

Within the competitive landscape of biopharmaceutical research, Veru differentiates itself through its focus on addressing both the efficacy and quality of treatment outcomes. By combining an innovative therapeutic approach with a clear focus on patient-centered endpoints—such as muscle preservation during weight loss—Veru has carved out a niche that appeals to clinicians and regulatory authorities alike. The Company's results have reinforced its credibility and fostered a portfolio that reflects a balanced interplay of innovation, scientific rigor, and market responsiveness.

Global Reach and Market Penetration

Veru’s impact is not confined solely to one region; rather, the Company strategically generates revenue from multiple markets including the United States, Brazil, and other international regions. This diverse geographical footprint not only underscores the universal applicability of its innovative therapies but also reflects a well-established distribution network that has historically supported products like the FC2 Female Condom®. Having been marketed in numerous countries, Veru’s legacy in consumer health products further complements its forward-thinking biopharmaceutical initiatives.

Commitment to Research, Innovation, and Expertise

Adhering to the highest E-E-A-T (Expertise, Experience, Authoritativeness, Trustworthiness) standards, Veru continuously invests in cutting-edge clinical research and drug development programs. The Company collaborates with leading academic institutions and clinical experts to refine its therapeutic approaches and ensure the best possible outcomes for patients. Through transparent communication, comprehensive safety monitoring, and an unwavering commitment to innovation, Veru has established itself as a trusted source of advanced therapeutic solutions in fields where medical needs are profound and evolving.

Future-Ready Therapeutic Development

Although Veru’s initiatives do not speculate on future market performance, its current clinical pipelines offer enduring relevance. The Company’s strategic focus on quality weight loss—by preserving muscle and selectively reducing fat—addresses critical concerns in an aging population where mobility and physical function are paramount. Simultaneously, its exploration of anti-inflammatory therapies in cardiovascular disease further illustrates the depth and continuity of its research endeavors.

Investor Insights and Analytical Perspectives

For investors and market analysts, Veru presents a compelling case study in the evolution of biopharmaceutical investment. Its dual focus on innovative therapeutic development and responsible clinical evaluation provides a solid framework for understanding its strategic initiatives. Information on product pipelines, clinical study designs, and departmental strategies is communicated with clarity and depth, allowing stakeholders to appreciate the scientific logic and measured approach underlying each business decision.

Conclusion

In summary, Veru Inc. is emblematic of a modern biopharmaceutical company that leverages deep clinical research, innovative drug development, and strategic market penetration to address significant health challenges. Its integrated approach—spanning weight management, oncology, cardiometabolic therapies, and sexual health—demonstrates a holistic commitment to therapeutic innovation and patient care. This comprehensive overview is designed to provide investors and researchers a well-structured and detailed insight into the Company’s operations, clinical rationale, and market positioning, underscoring Veru’s lasting impact in the competitive realm of advanced medicinal research.

Rhea-AI Summary

Veru Inc. announced a significant breakthrough in breast cancer research, revealing the androgen receptor acts as a tumor suppressor in ER+ breast cancer. Preclinical studies indicate that enobosarm, a selective androgen receptor agonist, shows potent antitumor activity in resistant cases. The Phase 3 ARTEST study for enobosarm is set to commence next quarter, targeting patients resistant to existing therapies. This research could change treatment approaches and emphasizes enobosarm's potential without unwanted side effects, marking a new era in breast cancer treatment.

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Veru Inc. (NASDAQ: VERU) announced its participation in the H.C. Wainwright Bioconnect 2021 Conference, with an on-demand presentation available from January 11-14, 2021. The webcast will also be archived for 90 days. Veru focuses on oncology, developing treatments for prostate and breast cancer, including investigational drugs such as VERU-111, VERU-100, and enobosarm. The company plans to advance various clinical trials throughout 2021.

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Veru Inc. (NASDAQ: VERU) announced promising results from its Phase 2 clinical trial for enobosarm, focused on ER+/HER2- metastatic breast cancer. Highlighted as a Spotlight Presentation at the 2020 San Antonio Breast Cancer Symposium, enobosarm showed a clinical benefit rate of 32% in a 136-patient cohort. The FDA has approved a Phase 3 ARTEST study, set to begin in Q2 2021, to further evaluate enobosarm's efficacy against active comparators in similar patient populations. This novel therapy offers hope for patients who have exhausted other treatment options.

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Veru Inc. (NASDAQ: VERU) presented promising preclinical data for VERU-111, showing its potential in treating triple negative breast cancer (TNBC) resistant to paclitaxel. Findings from the 2020 San Antonio Breast Cancer Symposium revealed that VERU-111 significantly inhibited tumor growth in both paclitaxel-sensitive and resistant models. The company plans to engage with the FDA in early 2021 to discuss advancing VERU-111 into a Phase 2b clinical trial for women with taxane-resistant TNBC, potentially leading to accelerated approval.

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Veru Inc. (NASDAQ: VERU) has completed its transformation into a late-stage oncology biopharmaceutical company focused on prostate and breast cancer therapies. It has licensed worldwide rights to enobosarm, an oral androgen receptor targeting agent for endocrine-resistant ER+ HER2- metastatic breast cancer. Veru plans to initiate four registration trials in 2021, including the ARTEST trial for enobosarm and studies for VERU-111 and VERU-100. The company expects to fund these trials through existing resources without the need for new equity financing until at least FY 2022.

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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.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of Veru (VERU)?

The current stock price of Veru (VERU) is $0.5698 as of April 4, 2025.

What is the market cap of Veru (VERU)?

The market cap of Veru (VERU) is approximately 81.9M.

What core therapeutic areas does Veru Inc. focus on?

Veru Inc. focuses on cardiometabolic diseases, oncology, acute respiratory distress syndrome (ARDS), and sexual health. Their innovative approach addresses crucial medical needs in these areas with advanced drug development programs.

What is enobosarm and how is it used?

Enobosarm is a novel, selective androgen receptor modulator (SARM) developed by Veru Inc. It is designed to help preserve muscle mass while selectively reducing fat, especially in older patients undergoing weight loss therapies with GLP-1 receptor agonists.

How does Veru ensure the safety of its clinical programs?

Veru follows rigorous clinical trial protocols including multicenter, double-blind, placebo-controlled studies. Their safety evaluations span several clinical trials, and they incorporate comprehensive data analysis to ensure that their therapeutic candidates meet high safety and efficacy standards.

What distinguishes Veru’s approach to weight management therapies?

Veru’s approach is unique because it focuses on improving the quality of weight loss by preserving lean muscle mass while enhancing fat loss. This tissue-selective strategy aims to mitigate the adverse effects associated with conventional weight loss treatments.

Does Veru have a global market presence?

Yes, Veru generates revenue from multiple international regions including the USA and Brazil among others. Their market reach is supported by a diversified portfolio that includes both innovative therapeutics and established consumer health products.

What role does sabizabulin play in Veru’s portfolio?

Sabizabulin is a microtubule disruptor developed as an anti-inflammatory agent targeting atherosclerotic cardiovascular disease. It offers potential advantages over traditional therapies by reducing inflammation with stable pharmacokinetics and a low risk of drug-drug interactions.

How does Veru communicate its clinical progress to investors?

Veru maintains transparency through detailed disclosures in press releases and investor communications. They provide comprehensive updates on clinical trial progress, study design, and safety data to ensure investors are well-informed about the Company’s developmental milestones.

How does Veru embody the principles of E-E-A-T?

Veru exemplifies Expertise, Experience, Authoritativeness, and Trustworthiness through its rigorous clinical research, expert-driven drug development processes, and transparent communication practices. The Company collaborates with leading professionals and adheres to high regulatory standards to build reliability in its therapeutic offerings.
Veru

Nasdaq:VERU

VERU Rankings

VERU Stock Data

81.86M
119.10M
14.21%
40.08%
9.36%
Biotechnology
Pharmaceutical Preparations
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United States
MIAMI