Veru Enrolls First Patient in Phase 2b PLATEAU Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
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Should l Buy VERU?
Veru announced that it has enrolled the first patient in its Phase 2b PLATEAU clinical trial of enobosarm, an oral selective androgen receptor modulator, SARM, to preserve muscle and physical function and to augment fat and weight loss when combined with semaglutide, a Glucagon-like peptide-1 receptor agonist drug, for potentially higher quality and quantity of weight loss in older patients with obesity.
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Analyst Views on VERU
Wall Street analysts forecast VERU stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.460
Low
25.00
Averages
25.00
High
25.00
Current: 2.460
Low
25.00
Averages
25.00
High
25.00
About VERU
Veru Inc. is a late clinical-stage biopharmaceutical company focused on developing medicines for the treatment of metabolic diseases, oncology, and acute respiratory distress syndrome (ARDS). Its drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator, is being developed for two indications: Phase 2b clinical QUALITY study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness, and Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive, estrogen receptor positive and human epidermal growth factor receptor 2 negative metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed for treatment of hospitalized patients with viral-induced ARDS.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Veru Initiates Phase 2b Clinical Trial for Enobosarm in Obesity Treatment
- Trial Launch: Veru has successfully enrolled the first patient in its Phase 2b PLATEAU clinical trial, aimed at assessing the effects of enobosarm combined with semaglutide on older obese patients, marking a significant advancement in obesity treatment.
- Study Design: The trial will recruit approximately 200 patients aged 65 and older with a BMI of 35 or higher, primarily evaluating the impact of enobosarm on total body weight, fat mass, and lean mass, with preliminary results expected at 68 weeks, which holds substantial clinical significance.
- Interim Analysis Plan: An interim analysis is anticipated in the first quarter of 2027 to assess changes in lean body mass and fat mass, providing critical data for the design of future Phase 3 clinical trials and advancing the development of next-generation obesity drugs.
- Market Demand: With increasing demand from obese patients for effective weight loss therapies, Veru's research aims to address this market gap by leveraging a combination therapy strategy with enobosarm to help patients break through weight loss plateaus and achieve higher quality weight loss outcomes.
See More
Veru Inc. to Present at Oppenheimer Healthcare Conference
- Executive Presentation: Veru's CEO, Mitchell Steiner, will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, which is expected to draw investor interest in the company's innovative drug development for cardiometabolic and inflammatory diseases.
- Clinical Trial Progress: The enobosarm drug showed positive results in the Phase 2b QUALITY trial, where 168 older patients demonstrated effective fat loss while preserving muscle mass when combined with GLP-1 RA therapy, likely boosting future market demand.
- New Study Plans: The company plans to initiate the Phase 2b PLATEAU clinical trial in Q1 2026, aimed at assessing the effects of enobosarm on weight, fat, and lean mass in older obese patients, which could provide a breakthrough in obesity treatment.
- Market Outlook: With the advancement of enobosarm's clinical studies, Veru is poised to capture significant market share in obesity treatment, particularly among patients receiving GLP-1 RA therapy, potentially achieving more pronounced weight reduction effects.
See More
Veru Inc. Q1 2026 Earnings Call Insights
- Clinical Pipeline Advancement: Veru is advancing its late-stage clinical pipeline, focusing on two oral small molecule drugs, enobosarm in combination with GLP-1 receptor agonists, aimed at improving weight loss outcomes in obese patients, particularly older individuals, demonstrating potential in preserving lean mass and physical function.
- Regulatory Clarity from FDA: Steiner noted two potential approval pathways for the enobosarm/GLP-1 combination during a recent FDA meeting, either achieving at least a 5% placebo-corrected weight loss at 52 weeks or demonstrating clinically meaningful benefits in physical function with less than 5% weight loss, indicating the company's regulatory clarity.
- Improved Financial Position: CFO Greco reported net proceeds of approximately $23.4 million, with R&D costs decreasing from $5.7 million to $1.3 million primarily due to the wind-down of the QUALITY study, showcasing effective cost control and enhanced cash flow.
- Future Outlook: Management expects the PLATEAU study to commence this quarter, targeting interim results in Q1 2027, emphasizing confidence in clinical trial design and regulatory strategy, despite ongoing challenges with profitability.
See More
Veru Reports Q1 2025 Earnings with Significant Cash Increase
- Earnings Beat: Veru's Q1 2025 GAAP EPS of -$0.26 surpassed expectations by $0.21, indicating an improvement in financial performance that may bolster investor confidence moving forward.
- Cash Position Strengthened: As of December 31, 2025, the company reported cash, cash equivalents, and restricted cash totaling $33.0 million, a significant increase from $15.8 million as of September 30, 2025, enhancing liquidity for future R&D and operations.
- Positive Stock Reaction: Following the earnings release, Veru's shares rose by 5%, reflecting market recognition of the company's financial health and potentially attracting more investor interest in its future developments.
- R&D Advancements: Veru is conducting a 72-week Phase IIb PLATEAU study targeting the obesity plateau population, adhering to FDA guidance, which demonstrates the company's ongoing commitment to innovative drug development and may lay the groundwork for future revenue growth.
See More
Veru Initiates Phase 2b Clinical Trial for Obesity Drug Enobosarm
- Trial Launch: Veru plans to initiate the Phase 2b PLATEAU clinical trial in Q1 2026 to evaluate the effects of enobosarm in combination with semaglutide on older patients with obesity, potentially offering a new solution for obesity treatment.
- Improved Financials: In Q1 FY2026, Veru's R&D expenses decreased to $1.3 million from $5.7 million year-over-year, demonstrating effective cost control, while operating losses were reduced from $10.2 million to $5.4 million, indicating an improvement in the company's financial health.
- Positive FDA Feedback: The company received clear regulatory guidance from the FDA in September 2025 regarding the development pathways for enobosarm in combination with GLP-1 RA, confirming that a 3mg dosage of enobosarm is suitable for future clinical development, paving the way for potential drug approval.
- Research Presentation: Veru showcased positive results from the Phase 2b QUALITY trial at the ObesityWeek conference in November 2025, indicating that enobosarm can promote fat loss while preserving muscle mass, providing a higher quality weight loss solution for patients with obesity.
See More
Veru Scheduled to Announce Q1 Earnings on February 11
- Earnings Announcement: Veru is set to announce its Q1 2023 earnings on February 11 before market open, with a consensus EPS estimate of -$0.47, indicating challenges in profitability.
- Earnings Estimate Changes: Over the last three months, Veru's EPS estimates have seen no upward revisions and one downward revision, reflecting analysts' diminishing confidence in the company's future earnings potential, which may impact investor sentiment.
- Clinical Study Progress: Veru is conducting a 72-week Phase IIb PLATEAU study targeting the obesity plateau population, following FDA guidance, which could support the company's future product pipeline and market positioning.
- Historical Financial Data: Veru's historical financial data and analyst ratings indicate volatility in the company's market performance, prompting investors to closely monitor the upcoming earnings report to assess future growth potential.
See More
Veru Initiates Phase 2b Clinical Trial for Enobosarm in Obesity Treatment
- Trial Launch: Veru has successfully enrolled the first patient in its Phase 2b PLATEAU clinical trial, aimed at assessing the effects of enobosarm combined with semaglutide on older obese patients, marking a significant advancement in obesity treatment.
- Study Design: The trial will recruit approximately 200 patients aged 65 and older with a BMI of 35 or higher, primarily evaluating the impact of enobosarm on total body weight, fat mass, and lean mass, with preliminary results expected at 68 weeks, which holds substantial clinical significance.
- Interim Analysis Plan: An interim analysis is anticipated in the first quarter of 2027 to assess changes in lean body mass and fat mass, providing critical data for the design of future Phase 3 clinical trials and advancing the development of next-generation obesity drugs.
- Market Demand: With increasing demand from obese patients for effective weight loss therapies, Veru's research aims to address this market gap by leveraging a combination therapy strategy with enobosarm to help patients break through weight loss plateaus and achieve higher quality weight loss outcomes.
See More
Veru Inc. to Present at Oppenheimer Healthcare Conference
- Executive Presentation: Veru's CEO, Mitchell Steiner, will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, which is expected to draw investor interest in the company's innovative drug development for cardiometabolic and inflammatory diseases.
- Clinical Trial Progress: The enobosarm drug showed positive results in the Phase 2b QUALITY trial, where 168 older patients demonstrated effective fat loss while preserving muscle mass when combined with GLP-1 RA therapy, likely boosting future market demand.
- New Study Plans: The company plans to initiate the Phase 2b PLATEAU clinical trial in Q1 2026, aimed at assessing the effects of enobosarm on weight, fat, and lean mass in older obese patients, which could provide a breakthrough in obesity treatment.
- Market Outlook: With the advancement of enobosarm's clinical studies, Veru is poised to capture significant market share in obesity treatment, particularly among patients receiving GLP-1 RA therapy, potentially achieving more pronounced weight reduction effects.
See More
Veru Inc. Q1 2026 Earnings Call Insights
- Clinical Pipeline Advancement: Veru is advancing its late-stage clinical pipeline, focusing on two oral small molecule drugs, enobosarm in combination with GLP-1 receptor agonists, aimed at improving weight loss outcomes in obese patients, particularly older individuals, demonstrating potential in preserving lean mass and physical function.
- Regulatory Clarity from FDA: Steiner noted two potential approval pathways for the enobosarm/GLP-1 combination during a recent FDA meeting, either achieving at least a 5% placebo-corrected weight loss at 52 weeks or demonstrating clinically meaningful benefits in physical function with less than 5% weight loss, indicating the company's regulatory clarity.
- Improved Financial Position: CFO Greco reported net proceeds of approximately $23.4 million, with R&D costs decreasing from $5.7 million to $1.3 million primarily due to the wind-down of the QUALITY study, showcasing effective cost control and enhanced cash flow.
- Future Outlook: Management expects the PLATEAU study to commence this quarter, targeting interim results in Q1 2027, emphasizing confidence in clinical trial design and regulatory strategy, despite ongoing challenges with profitability.
See More
Veru Reports Q1 2025 Earnings with Significant Cash Increase
- Earnings Beat: Veru's Q1 2025 GAAP EPS of -$0.26 surpassed expectations by $0.21, indicating an improvement in financial performance that may bolster investor confidence moving forward.
- Cash Position Strengthened: As of December 31, 2025, the company reported cash, cash equivalents, and restricted cash totaling $33.0 million, a significant increase from $15.8 million as of September 30, 2025, enhancing liquidity for future R&D and operations.
- Positive Stock Reaction: Following the earnings release, Veru's shares rose by 5%, reflecting market recognition of the company's financial health and potentially attracting more investor interest in its future developments.
- R&D Advancements: Veru is conducting a 72-week Phase IIb PLATEAU study targeting the obesity plateau population, adhering to FDA guidance, which demonstrates the company's ongoing commitment to innovative drug development and may lay the groundwork for future revenue growth.
See More
Veru Initiates Phase 2b Clinical Trial for Obesity Drug Enobosarm
- Trial Launch: Veru plans to initiate the Phase 2b PLATEAU clinical trial in Q1 2026 to evaluate the effects of enobosarm in combination with semaglutide on older patients with obesity, potentially offering a new solution for obesity treatment.
- Improved Financials: In Q1 FY2026, Veru's R&D expenses decreased to $1.3 million from $5.7 million year-over-year, demonstrating effective cost control, while operating losses were reduced from $10.2 million to $5.4 million, indicating an improvement in the company's financial health.
- Positive FDA Feedback: The company received clear regulatory guidance from the FDA in September 2025 regarding the development pathways for enobosarm in combination with GLP-1 RA, confirming that a 3mg dosage of enobosarm is suitable for future clinical development, paving the way for potential drug approval.
- Research Presentation: Veru showcased positive results from the Phase 2b QUALITY trial at the ObesityWeek conference in November 2025, indicating that enobosarm can promote fat loss while preserving muscle mass, providing a higher quality weight loss solution for patients with obesity.
See More
Veru Scheduled to Announce Q1 Earnings on February 11
- Earnings Announcement: Veru is set to announce its Q1 2023 earnings on February 11 before market open, with a consensus EPS estimate of -$0.47, indicating challenges in profitability.
- Earnings Estimate Changes: Over the last three months, Veru's EPS estimates have seen no upward revisions and one downward revision, reflecting analysts' diminishing confidence in the company's future earnings potential, which may impact investor sentiment.
- Clinical Study Progress: Veru is conducting a 72-week Phase IIb PLATEAU study targeting the obesity plateau population, following FDA guidance, which could support the company's future product pipeline and market positioning.
- Historical Financial Data: Veru's historical financial data and analyst ratings indicate volatility in the company's market performance, prompting investors to closely monitor the upcoming earnings report to assess future growth potential.
See More
