BofA warns Fed risks policy mistake with early rate cuts
MIAMI - Veru Inc. (NASDAQ:VERU), a pharmaceutical company with a market capitalization of $91 million, announced Tuesday that its Phase 2b Maintenance Extension clinical trial showed enobosarm 3mg significantly reduced weight regain by 46% compared to placebo after discontinuation of semaglutide, a GLP-1 receptor agonist. The company’s stock has shown strong momentum, gaining nearly 7% in the past week despite broader market volatility. InvestingPro analysis indicates the stock is currently trading below its Fair Value.
The 12-week study evaluated patients who had completed the company’s Phase 2b QUALITY weight loss trial. After discontinuing semaglutide, the placebo group regained 43% of previously lost body weight, while the enobosarm 3mg group showed significantly less weight regain. The company reported that enobosarm completely prevented fat regain compared to placebo. While Veru’s revenue has grown 134% over the last twelve months, InvestingPro data shows the company is actively managing its financial position with a healthy current ratio of 3.8 and minimal debt-to-equity of 0.16.
According to the trial results, enobosarm treatment led to up to 93% greater loss of fat mass and 100% preservation of lean mass compared to placebo by the end of the study. The drug demonstrated a positive safety profile with minimal gastrointestinal side effects during the maintenance period.
The study included 148 participants who were randomized to receive either placebo, enobosarm 3mg, or enobosarm 6mg as monotherapy after discontinuing semaglutide treatment.
"Enobosarm provides a compelling option for patients that would like to maintain their weight loss and fat loss after discontinuing semaglutide," said Mitchell Steiner, Chairman, President, and CEO of Veru.
Based on these results, Veru has selected the 3mg dose of enobosarm to advance to Phase 3 clinical trials. The company has been granted a meeting with the FDA to discuss the Phase 3 program.
Donna Ryan, Professor Emerita at Pennington Biomedical of Louisiana State University, noted the importance of muscle preservation with enobosarm, especially for older patients at risk of lean mass loss during weight reduction.
The information in this article is based on a company press release statement.
In other recent news, Veru Inc. reported its Q2 2025 earnings, surpassing analyst expectations with an earnings per share (EPS) of -$0.05, compared to the forecasted -$0.06. This performance reflects the company’s efforts to manage costs, with a notable reduction in selling, general, and administrative expenses. Veru is strategically shifting its focus towards drug development, having sold its FC2 Female Condom business for $18 million. The company is advancing its clinical trials for enobosarm, selecting a 3mg dose for upcoming Phase 3 trials after positive results in a Phase 2b study. The trial demonstrated significant fat loss and lean mass preservation in older patients when enobosarm was combined with semaglutide. Veru plans to meet with the FDA to discuss the Phase 3 trial design and is exploring non-dilutive funding opportunities through pharmaceutical partnerships. Additionally, the company is developing a novel, patentable, modified release oral formulation of enobosarm, with a patent expiry anticipated in 2045. These developments indicate Veru’s continued focus on its drug pipeline amidst ongoing financial challenges.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.