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MIAMI - Veru Inc. (NASDAQ:VERU), a $52.3 million market cap biopharmaceutical company that has seen remarkable revenue growth of 337% over the last twelve months, announced Tuesday that the FDA has provided regulatory clarity for its drug candidate enobosarm, a selective androgen receptor modulator being developed to preserve muscle mass in combination with GLP-1 receptor agonists for obesity treatment. According to InvestingPro data, the company’s stock currently trades at $3.57, with analyst price targets ranging from $4 to $30.
According to the company’s press release statement, the FDA now accepts incremental weight loss as a primary endpoint for approval when enobosarm is added to GLP-1 receptor agonist treatment. The agency also confirmed that the 3mg dosage of enobosarm is acceptable for future clinical development and encouraged Veru to include younger patients with obesity in its studies. InvestingPro analysis shows that while the company maintains a strong balance sheet with more cash than debt, it’s currently experiencing rapid cash burn - a critical factor for investors to monitor as clinical trials progress.
Veru plans to initiate a Phase 2b clinical trial called PLATEAU in the first quarter of 2026, pending sufficient capital. The study will evaluate enobosarm 3mg in approximately 180 older and younger patients with obesity who are starting tirzepatide treatment for weight reduction.
The primary endpoint of the planned study will measure percent change in total body weight at 72 weeks. Secondary endpoints include changes in fat mass, lean mass, physical function, bone mineral density, and patient-reported outcomes.
The company’s previous Phase 2b QUALITY study showed that enobosarm treatment preserved lean mass, reduced fat mass, and improved physical function in older patients with obesity who were receiving semaglutide for weight reduction over a 16-week period.
Mitchell Steiner, Veru’s Chairman, President and CEO, stated that the FDA’s current regulatory position provides "a more certain regulatory pathway" for enobosarm’s development in obesity treatment.
Veru is a late clinical stage biopharmaceutical company focused on developing medicines for cardiometabolic and inflammatory diseases. The company is also developing sabizabulin, a microtubule disruptor, for treating inflammation in atherosclerotic cardiovascular disease. While the company reported an EBITDA of -$38.17M in the last twelve months, InvestingPro analysis suggests the stock is slightly undervalued at current levels. For deeper insights into Veru’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, along with 8 additional ProTips and extensive financial metrics.
In other recent news, Veru Inc. reported its third-quarter financial results for fiscal year 2025, revealing a significant earnings per share (EPS) miss. The company posted an EPS of -$0.50, which was substantially below the forecasted -$0.05, missing expectations by 900%. Despite effective expense management, this earnings miss has drawn attention as the company prepares for an End-of-Phase 2 meeting with the FDA regarding its Enobosarm obesity program. Oppenheimer has responded to Veru’s progress with its GLP-1 muscle loss drug by raising its price target from $4.00 to $25.00, maintaining an Outperform rating. Meanwhile, Raymond James has adjusted its price target for Veru to $20.00 from $30.00, also maintaining an Outperform rating. These developments highlight the varying analyst perspectives on Veru’s potential in the pharmaceutical sector. The company’s strategic moves and financial performance continue to be closely monitored by investors.
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