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Veru Inc

Veru Inc., a late clinical stage biopharmaceutical company, focuses on developing medicines for treatment of metabolic diseases, oncology, and viral-induced acute respiratory distress syndrome (ARDS) in Florida and internationally. It provides FC2 female condom for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. The company develops enobosarm, a selective androgen receptor modulator for treatment of augment fat loss and to prevent muscle loss in sarcopenic obese and overweight elderly patients; Enobosarm, an oral selective androgen receptor modulator for the treatment of AR+ ER+ HER2- metastatic breast cancer; and sabizabulin, a microtubule disruptor for the treatment of hospitalized patients with viral lung infection at high risk for viral induced ARDS and death. The company was formerly known as The Female Health Company and changed its name to Veru Inc. in July 2017. Veru Inc. was incorporated in 1971 and is headquartered in Miami, Florida.

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Biotech & Genomic Medicine2

Veru targets Q1 2027 PLATEAU interim analysis after enrolling 239 patients

Veru Inc. has fully enrolled its Phase IIb PLATEAU clinical trial with 239 patients and expects 32-week interim results in the first quarter of calendar year 2027, with final data by the fourth quarter of 2027. The trial is evaluating enobosarm combined with a GLP-1 receptor agonist to preserve lean mass and physical function in older patients with obesity. Veru also disclosed a supply agreement under which Novo Nordisk will provide Wegovy at no charge, while Veru retains full global rights to enobosarm and granted Novo Nordisk a right of first negotiation for combinations. The company received a USPTO notice of allowance for a methods-of-use patent covering enobosarm with weight loss drugs, with an expiry of at least October 3, 2044. For the fiscal third quarter, Veru reported a net loss of $7 million, or $0.30 per diluted share, with cash and equivalents of $23.9 million as of June 30, 2026, which management expects to fund operations beyond the interim analysis.
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Biotech & Genomic Medicine2

Veru Completes Enrollment for Phase 2b PLATEAU Trial of Enobosarm and Semaglutide Combination

Veru Inc. announced the completion of enrollment in its Phase 2b PLATEAU clinical study, exceeding the targeted 200 patients. The trial is evaluating oral enobosarm 3 mg versus placebo on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety in older patients with obesity who are initiating semaglutide treatment. Interim analysis results are expected in the first quarter of calendar year 2027, with final topline data anticipated in the fourth quarter of calendar year 2027. The study is designed to assess whether enobosarm can break through the weight loss plateau observed with GLP-1 receptor agonists by preserving muscle mass and physical function. Veru is developing enobosarm as a potential next-generation combination therapy with GLP-1 receptor agonists for higher quality weight reduction in older patients with obesity.
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Biotech & Genomic Medicine

Veru to Present Enobosarm Data at 2026 Obesity & Weight Loss Drug Development Summit

Veru Inc. announced it will present at the 2026 4th Annual Obesity & Weight Loss Drug Development Summit and its pre-conference workshop day, taking place July 14-16 in Boston. Chairman, President and CEO Mitchell Steiner will deliver a presentation on July 15 titled 'Combating Sarcopenic Obesity in Geriatrics by Combining GLP-1s with Selective Androgen Receptor Modulators (SARMs) to Prevent Muscle Loss,' focusing on the company's lead candidate enobosarm. Chief Scientific Officer Gary Barnette will participate in a July 14 workshop session on moving beyond BMI and weight-loss endpoints to advance the regulatory frontier with the FDA. Veru is currently enrolling a Phase 2b PLATEAU study evaluating enobosarm in combination with semaglutide in approximately 200 older patients with obesity, with an interim analysis expected in the first quarter of 2027 and topline data in the fourth quarter of 2027.
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