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MIAMI - Veru Inc. (NASDAQ:VERU), a clinical-stage biopharmaceutical company whose stock has declined over 22% in the past week according to InvestingPro data, has selected a novel modified release oral formulation for enobosarm, its selective androgen receptor modulator being developed for chronic weight loss management, the company announced Monday.
The selection follows a single dose, open label pilot study that confirmed the formulation achieved its intended pharmacokinetic profile. The modified release version demonstrated reduced maximum plasma concentration, delayed time to maximum concentration, a distinct secondary peak plasma concentration, and similar absorption compared to immediate release capsules.
The company stated the formulation’s manufacturing process is protected by global patents with protection through 2037. New patent applications have been filed for the formulation which, if issued, could extend protection until 2046.
"This novel modified release oral enobosarm formulation is planned to be available for the Phase 3 clinical studies and for commercialization," said Mitchell Steiner, Chairman, President, and Chief Executive Officer of Veru.
The formulation was developed in collaboration with Laxxon Medical using the latter’s proprietary SPID-Technology to create unique oral delivery release profiles.
Veru previously reported positive results from its Phase 2b QUALITY clinical study evaluating enobosarm in older patients receiving semaglutide (Wegovy) for weight management. According to a June announcement, the study showed enobosarm significantly reduced body weight regain and prevented fat regain after semaglutide discontinuation.
The company has been granted an FDA meeting to discuss its Phase 3 program for enobosarm.
Veru is a late clinical stage biopharmaceutical company developing medicines for cardiometabolic and inflammatory diseases. The information in this article is based on a company press release statement.
In other recent news, Veru Inc. announced a 1-for-10 reverse stock split to regain compliance with Nasdaq listing requirements. This change will consolidate every ten shares of outstanding common stock into one share, with trading on a split-adjusted basis set to begin on August 11, 2025. Additionally, Veru reported positive results from its Phase 2b Maintenance Extension clinical trial, where the drug enobosarm 3mg significantly reduced weight regain by 46% compared to a placebo after discontinuation of semaglutide. The study highlighted that enobosarm completely prevented fat regain relative to the placebo group.
Following these promising results, Veru has chosen the 3mg dose of enobosarm for its upcoming Phase 3 trials, citing a favorable safety profile and fewer gastrointestinal side effects when combined with semaglutide. The company plans to meet with the FDA to discuss the next steps for this clinical program. These developments reflect Veru’s ongoing efforts to advance its clinical programs and maintain its market position.
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