Back to top

Analyst Blog

Repros Therapeutics Inc.’s (RPRX - Snapshot Report) share price increased 1.2% last week on the announcement that the company has initiated two studies on its secondary hypogonadism candidate, Androxal. Since then, the company has gained approximately 5.4%.

The two identical, 17-week, double-blinded, placebo controlled studies will compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) in restoring and maintaining testicular function. Both studies will enroll 120 men each. Top-line data from the studies are expected by Oct 2014. Repros plans to submit the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2014.

Repros has already obtained the Investigational Review Board approval for several of the study sites. Meanwhile, several sites have started pre-screening patients with the drug shipment for the trial expected shortly.

We remind investors that the company had received guidance from the FDA related to the Androxal development program in Oct 2013. In view of the guidance, Repros delayed the regulatory submission from the previously expected timeline of mid-2014.

Last year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301) and the second pivotal efficacy study (ZA-302), which evaluated Androxal for secondary hypogonadism. Both ZA-301 and ZA-302 – conducted under the FDA’s Special Protocol Assessment (SPA) program – had met their respective primary endpoints.

We believe that Repros stands to benefit from the additional trials as data, if positive, can be added to the label. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc.’s (ABBV - Analyst Report) AndroGel.

Repros currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on Androxal updates. Some better-ranked stocks in the biopharma space include Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals (JAZZ - Analyst Report). Both carry a Zacks Rank #1 (Strong Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
QIHOO 360 T… QIHU 95.04 +4.95%
PILGRIM'S P… PPC 31.52 +3.72%
CLAYTON WIL… CWEI 138.97 +3.55%
CALLON PETE… CPE 11.50 +3.14%
ACTELION LT… ALIOF 124.80 +2.97%