At one point this morning, Veru Inc. (VERU) was up more than 70% with a trading volume of more than 82 million. That’s a big jump from its average daily trading volume of 1.7 million. This biopharmaceutical company only has a market cap of $652 million, but investors seem quite pleased with the positive data the company presented at the San Antonio Breast Cancer Symposium. 

VERU is a biopharmaceutical company focused on urology and oncology. It develops prescription products for benign prostatic hyperplasia hot flashes associated with cancer treatment, male infertility, and novel chemotherapies for various cancers. The company currently operates in two reporting segments: Commercial and Research and Development.

While not a big name in the market, investors may know the company from commercials for its online men’s healthcare business, Roman. Roman provides prescription and treatment options for various men’s health issues, including hair loss, testosterone, and erectile dysfunction. But the company recently sold off this business to Roman Health Ventures for $20 million and has transformed into a late clinical-stage oncology biopharmaceutical company focused on two of the most prevalent cancers: prostate cancer and breast cancer. The positive developments in its drug candidates are what is driving its stock higher today.

The big news was that the company reported positive data from the second Phase 2 trial evaluating enobosarm for the treatment of endocrine and chemotherapy-resistant ER+/HER2- metastatic breast cancer. The study demonstrated a clinical benefit rate of 32% and 29% in the 9mg and 18mg daily enobosarm AR+ cohorts. The trial’s patients also reported significant improvements in quality of life measurements, including anxiety/depression, mobility, and pain discomfort.

In the first enobosarm Phase 2 study, enobosarm 9mg dosing was evaluated in 22 heavily pretreated women. Enobosarm demonstrated a clinically meaningful six-month clinical benefit rate of 35.3% with a favorable safety profile.

The company also reported that its preclinical data demonstrated the efficacy of oral VERU-111 in the treatment of human derived animal models of triple-negative breast cancer. VERU-111 is an oral cytoskeleton disruptor that is being evaluated in both Phase 1b and Phase 2 clinical trials in men with metastatic castration-resistant prostate cancer. In these trials, VERU-111 showed significant antitumor efficacy and was well tolerated by patients.

VERU-111 is also being considered for Metastatic triple-negative breast cancer, which is an aggressive form of breast cancer present in approximately 15% of all breast cancers. This form of breast cancer is resistant to endocrine therapies. VERU said VERU-111 demonstrated efficacy in preclinical models of human triple-negative breast cancer. The company plans to meet with FDA and advance VERU-111 into a Phase 2b trial in women with paclitaxel-resistant triple-negative breast cancer in 2021.

Last week, H.C. Wainright raised its price target for the company based on its drug candidate, enobosarm. The firm raised its price target from $6 to $8 and maintained its ‘Buy’ rating. In addition, Brookline Capital raised its price target to $17. The company also reported its latest earnings results last week, wherein earnings per share rose 160% year over year and beat the consensus estimate. Revenue came in at $11.75 million, up 34.61% year over year.

The stock is rated a “Buy” in our POWR Ratings system. It holds a grade of “A” for Trade Grade and Industry Rank and a “B” for Peer Grade. Those are three of the four components that make up the POWR Ratings. VERU is also ranked #49 out of 240 stocks in the Medical – Pharmaceuticals industry.

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VERU shares were trading at $9.32 per share on Monday afternoon, up $2.97 (+46.77%). Year-to-date, VERU has gained 178.21%, versus a 15.61% rise in the benchmark S&P 500 index during the same period.

About the Author: David Cohne

David Cohne has 20 years of experience as an investment analyst and writer. Prior to StockNews, David spent eleven years as a consultant providing outsourced investment research and content to financial services companies, hedge funds, and online publications. David enjoys researching and writing about stocks and the markets. He takes a fundamental quantitative approach in evaluating stocks for readers. More...

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