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GTx: Promising Data At SUFU And Catalysts Suggest Additional Upside


  • The stock has been on a tear.
  • Results today confirmed that enobosarm has substantial potential in treating SUI.
  • Downside appears to be somewhat diminished at this point due to the strength of the data.
  • The potential of the drug to treat urge incontinence indicates broader potential and additional upside as well. A second trial should release results in the second half of the year.
  • The stock could be due for a breather after an enormous run since last June. While not currently an ROTY Contender, additional upside is still likely and I will be keeping an eye on it.

Shares of GTx (GTXI) have practically doubled over the past six months.

The stock crossed my scans today after they announced additional data from a mid-stage study evaluating enobosarm in postmenopausal women with stress urinary incontinence (SUI). Results were presented in a podium presentation at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting a couple days ago.

In the single-arm, open-label study, 19 postmenopausal women were enrolled to receive the study drug (should be noted was the first study to evaluate an orally administered selective androgen receptor modulator for SUI). 18 patients finished treatment while one dropped out after her first clinical visit.

As had previously been shown, every patient who was treated demonstrated a clinically meaningful decrease in the primary endpoint (stress urinary incontinence episodes per day). Mean stress leaks declined by 81% and from a mean of 5.17 leaks per day to 1 leak per day after 12 weeks of treatment. The durability of effect was also impressive, with no patient to date (including 9 who have passed seven months post treatment) returning to baseline level of SUI episodes. It's very important that several quality of life measurements also showed significant improvement (Patient Global Impression of Improvement, Urogenital Distress Inventory and Incontinence Impact Questionnaire). The safety profile continues to appear solid, with an absence of serious adverse events and other side effects being mild in nature for the most part.

New MRI data measured muscle in the pelvic floor of 17 women after 12 weeks of treatment as compared to baseline with a substantial increase in several measurements observed. These included mean levator ani muscle thickness increase of 1.15 mm (p=0.006), mean inner urethral muscle diameter increase of 0.7 mm (p=0.002), and mean outer urethral muscle diameter increase of 0.7mm (p=0.0003).

Another encouraging development

This article was written by

Jonathan Faison profile picture
Community of Biotech Investors Focused on Value & Clinical Momentum

Founder of 500+ member ROTY Biotech Community (try the 2-week free trial to see if it adds value for you). Quality over quantity- enjoy connecting with readers.

Analyst’s Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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