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GTx's (GTXI) Enobosarm Positive In Phase II Study; Shares Up

Published 06/12/2017, 10:14 PM
Updated 07/09/2023, 06:31 AM

GTx, Inc.’s (NASDAQ:GTXI) shares have climbed almost 99% after the company announced positive preliminary data from a phase II study, evaluating the lead pipeline candidate enobosarm 3 mg (GTx-024) for treating postmenopausal women with stress urinary incontinence (SUI). Additional data will be presented later in 2017.

Shares of GTx have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has gained 16.5% compared with the broader industry’s increase of 2.2%.



The proof-of-concept phase II study was initiated in the first quarter of 2016. In this study, enobosarm is administered to post-menopausal women who have showed SUI symptoms for more than six months.

The study revealed that women treated with enobosarm lead to a significant reduction in incontinence episodes per day with decrease in mean stress leaks by over 80% from baseline across 12 weeks. Adverse events reported in the study are minimal.

Notably, enobosarm has already been evaluated in 24 completed or ongoing clinical trials enrolling over 1,700 subjects, of which approximately 1,200 subjects were treated with enobosarm at doses, ranging from 0.1 mg to 100 mg.

Investors are reminded that presently the company is conducting another phase II study, evaluating enobosarm in patients whose advanced breast cancer is both estrogen receptor (ER) positive and androgen receptor (AR) positive.

Top-line data from the trial is expected in the third quarter of 2017. Additionally, enobosarm is also studied in another phase II study for treatment of patients with advanced AR triple-negative breast cancer (TNBC).

Per company’s press release, SUI affects up to 50% of adult women in the U.S. SUI is the most common type of urinary problem suffered by women. Hence, approval of the candidate as a drug would provide the company with access to a huge population base of patients suffering from the disease in the U.S.

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Key Picks

Some favorably placed stocks in healthcare sector include VIVUS, Inc. (NASDAQ:VVUS) , Bayer (DE:BAYGN) AG (OTC:BAYRY) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) . While VIVUS and Bayer sports a Zacks Rank #1 (Strong Buy), Regeneron carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 in last 60 days. The company posted positive earnings surprises in all four trailing quarters with an average beat of 233.69%.

Bayer’s earnings per share estimates increased from $8.75 to $8.89 for 2017 and from $9.41 to $9.57 for 2018, over last 30 days. The company posted positive earnings surprises in three of four trailing quarters with average beat of 10.25%.

Regeneron’s earnings per share estimates increased from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over last 60 days. The company posted positive earnings surprises in two of four trailing quarters with average beat of 0.45%.

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Bayer AG (BAYRY): Free Stock Analysis Report

Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report

VIVUS, Inc. (VVUS): Free Stock Analysis Report

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